Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (NCT NCT02408523)

Last Updated: 2020-12-17

Results Overview

The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

242 participants

Primary outcome timeframe

During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

Results posted on

2020-12-17

Participant Flow

The study started to enroll patients in April 2015 and concluded in May 2019.

Completed study was defined as meeting any exit criteria or completing the 24-week Treatment Period with \< 2 PGTCS. After Treatment Period participants enrolled either in a 4-week Transition Period (entered EP0012) or up to a 4-week Taper Period and a 30-day Safety Follow-up Period (did not enter EP0012). Participant Flow refers to the Safety Set.

Participant milestones

Participant milestones
Measure	Placebo Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).	Lacosamide Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).
Overall Study STARTED	121	121
Overall Study Completed Treatment Period	110	103
Overall Study Enrolled Transition Period	108	101
Overall Study Enrolled Taper Period	7	9
Overall Study Enrolled Safety Folllow-up Period	10	11
Overall Study COMPLETED	110	103
Overall Study NOT COMPLETED	11	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).	Lacosamide Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).
Overall Study Adverse Event	4	10
Overall Study Lack of Efficacy	0	1
Overall Study Protocol Violation	1	2
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	3	1
Overall Study Sponsor request	1	0
Overall Study Did not satisfy extension conditions	0	1

Baseline Characteristics

A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=121 Participants Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).	Lacosamide n=121 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg).	Total Title n=242 Participants
Age, Categorical <=18 years	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	93 Participants n=5 Participants	92 Participants n=7 Participants	185 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	27.64 years STANDARD_DEVIATION 12.45 • n=5 Participants	27.82 years STANDARD_DEVIATION 13.13 • n=7 Participants	27.73 years STANDARD_DEVIATION 12.77 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	66 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	55 Participants n=7 Participants	100 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	89 Participants n=5 Participants	97 Participants n=7 Participants	186 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

Population: The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period. 1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=121 Participants Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Full Analysis Set (FAS).	Lacosamide (FAS) n=118 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the FAS.
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)	76 events	49 events

SECONDARY outcome

Timeframe: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=121 Participants Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Full Analysis Set (FAS).	Lacosamide (FAS) n=118 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the FAS.
Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)	17.3 percentage of participants Interval 10.3 to 24.3	31.0 percentage of participants Interval 22.4 to 39.6

SECONDARY outcome

Timeframe: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

The secondary efficacy variable was the time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of first PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to the number of events for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=121 Participants Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Full Analysis Set (FAS).	Lacosamide (FAS) n=118 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the FAS.
Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)	97 events	79 events

SECONDARY outcome

Timeframe: From Visit 1 (Week -4) to End of Study Period (up to Week 36)

Population: The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=121 Participants Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Full Analysis Set (FAS).	Lacosamide (FAS) n=121 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the FAS.
Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator	81.8 percentage of participants	82.6 percentage of participants

SECONDARY outcome

Timeframe: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

Population: The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo. Data not collected from participants in Placebo (SS) Arm/Group.

Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL). Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs.

Outcome measures

Outcome measures
Measure	Placebo (FAS) Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Full Analysis Set (FAS).	Lacosamide (FAS) n=121 Participants Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the FAS.
Plasma Concentrations of Lacosamide Visit 5, Week 6 (Titration)	—	8.610961 ug/mL Standard Deviation 3.705438
Plasma Concentrations of Lacosamide Visit 10, Week 24 (Maintenance)	—	8.074427 ug/mL Standard Deviation 3.948749
Plasma Concentrations of Lacosamide Early Termination Visit	—	8.138085 ug/mL Standard Deviation 4.913627

Adverse Events

Placebo (SS) Treatment Period

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Lacosamide (SS) Treatment Period

Serious events: 8 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo (SS) Transition Period

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Lacosamide (SS) Transition Period

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (SS) Taper Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Lacosamide (SS) Taper Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (SS) Safety Follow-up Period

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Lacosamide (SS) Safety Follow-up Period

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (SS) Treatment Period n=121 participants at risk Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Safety Set (SS).	Lacosamide (SS) Treatment Period n=121 participants at risk Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the SS.	Placebo (SS) Transition Period n=108 participants at risk At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Placebo in the Treatment Period transitioned to double-blind Lacosamide: Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 100 mg/day until final dose of 400 mg/day at Week 4 for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day at Week 1. Weekly increase in steps of 2 mg/kg/day until final dose of 8 mg/kg/day at Week 4 for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Lacosamide (SS) Transition Period n=101 participants at risk At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Lacosaminde in the Treatment Period continued to receive double-blind Lacosamide: Lacosamide 50 mg tablets: minim (min) 300 mg/day to maximum (max) 400 mg/day from Week 1 to Week 3 and final dose of 400 mg/day at Week 4 for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: min 8 mg/kg/day to max 12 mg/kg/day from Week 1 to Week 4 for pediatric participants \< 30 kg. Lacosamide oral solution 10 mg/ml: min 6 mg/kg/day to max 8 mg/kg/day from Week 1 to Week 3 and final dose of 8 mg/kg/day at Week 4 for pediatric participants 30 kg to \< 50 kg. Participants formed the SS.	Placebo (SS) Taper Period n=7 participants at risk Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Placebo in the Treatment Period continued to receive Placebo: Placebo 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Lacosamide (SS) Taper Period n=9 participants at risk Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Lacosamide in the Treatment Period continued to receive Lacosamide: Lacosamide 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Placebo (SS) Safety Follow-up Period n=10 participants at risk There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.	Lacosamide (SS) Safety Follow-up Period n=11 participants at risk There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.
Gastrointestinal disorders Abdominal pain	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Gastrointestinal disorders Nausea	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Gastrointestinal disorders Vomiting	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
General disorders Asthenia	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Infections and infestations Upper respiratory tract infection	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Injury, poisoning and procedural complications Contusion	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Injury, poisoning and procedural complications Femur fracture	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Injury, poisoning and procedural complications Road traffic accident	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Injury, poisoning and procedural complications Head injury	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Investigations Transaminases increased	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Investigations Liver function test abnormal	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Dizziness	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	1.7% 2/121 • Number of events 2 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Somnolence	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	1.7% 2/121 • Number of events 2 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Grand mal convulsion	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Headache	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Status epilepticus	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.83% 1/121 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Clonic convulsion	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	10.0% 1/10 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Surgical and medical procedures Abortion induced	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.

Other adverse events

Other adverse events
Measure	Placebo (SS) Treatment Period n=121 participants at risk Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants \< 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the Safety Set (SS).	Lacosamide (SS) Treatment Period n=121 participants at risk Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (\>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (\<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to \< 50 kg). Participants formed the SS.	Placebo (SS) Transition Period n=108 participants at risk At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Placebo in the Treatment Period transitioned to double-blind Lacosamide: Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 100 mg/day until final dose of 400 mg/day at Week 4 for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day at Week 1. Weekly increase in steps of 2 mg/kg/day until final dose of 8 mg/kg/day at Week 4 for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Lacosamide (SS) Transition Period n=101 participants at risk At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Lacosaminde in the Treatment Period continued to receive double-blind Lacosamide: Lacosamide 50 mg tablets: minim (min) 300 mg/day to maximum (max) 400 mg/day from Week 1 to Week 3 and final dose of 400 mg/day at Week 4 for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: min 8 mg/kg/day to max 12 mg/kg/day from Week 1 to Week 4 for pediatric participants \< 30 kg. Lacosamide oral solution 10 mg/ml: min 6 mg/kg/day to max 8 mg/kg/day from Week 1 to Week 3 and final dose of 8 mg/kg/day at Week 4 for pediatric participants 30 kg to \< 50 kg. Participants formed the SS.	Placebo (SS) Taper Period n=7 participants at risk Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Placebo in the Treatment Period continued to receive Placebo: Placebo 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants \>= 50 kg. Placebo oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Lacosamide (SS) Taper Period n=9 participants at risk Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Lacosamide in the Treatment Period continued to receive Lacosamide: Lacosamide 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants \>= 50 kg. Lacosamide oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants \< 30 kg and 0 kg to \< 50 kg. Participants formed the SS.	Placebo (SS) Safety Follow-up Period n=10 participants at risk There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.	Lacosamide (SS) Safety Follow-up Period n=11 participants at risk There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.
Ear and labyrinth disorders Vertigo	1.7% 2/121 • Number of events 2 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	6.6% 8/121 • Number of events 8 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	2.8% 3/108 • Number of events 4 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Gastrointestinal disorders Nausea	5.8% 7/121 • Number of events 7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	9.1% 11/121 • Number of events 12 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	1.9% 2/108 • Number of events 3 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Gastrointestinal disorders Vomiting	0.83% 1/121 • Number of events 3 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	5.8% 7/121 • Number of events 10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	2.8% 3/108 • Number of events 5 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Gastrointestinal disorders Dyspepsia	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	14.3% 1/7 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
General disorders Fatigue	5.0% 6/121 • Number of events 6 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	6.6% 8/121 • Number of events 8 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	1.9% 2/108 • Number of events 2 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Infections and infestations Nasopharyngitis	3.3% 4/121 • Number of events 4 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	6.6% 8/121 • Number of events 12 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	1.9% 2/108 • Number of events 2 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.99% 1/101 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Infections and infestations Upper respiratory tract infection	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	14.3% 1/7 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Injury, poisoning and procedural complications Laceration	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	11.1% 1/9 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Investigations Hepatic enzyme increased	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	14.3% 1/7 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Dizziness	5.8% 7/121 • Number of events 7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	21.5% 26/121 • Number of events 34 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	9.3% 10/108 • Number of events 10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	3.0% 3/101 • Number of events 3 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Somnolence	14.0% 17/121 • Number of events 17 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	14.9% 18/121 • Number of events 19 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	6.5% 7/108 • Number of events 7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Headache	9.9% 12/121 • Number of events 13 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	13.2% 16/121 • Number of events 18 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	4.6% 5/108 • Number of events 5 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/9 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Drooling	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	11.1% 1/9 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.
Nervous system disorders Grand mal convulsion	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/121 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/108 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/101 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/7 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	11.1% 1/9 • Number of events 1 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/10 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.	0.00% 0/11 • Adverse events were collected from Week 1 to End of Study Period (up to Week 36). TEAEs counts are for each study period: Treatment Period, Transition Period for participants who entered EP0012 (NCT02408549) and Taper Period followed by Safety Follow-up Period for participants not entering EP0012. AEs reported for PBO participants during the Transition Period occur when they have switched to LCM.

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