Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

Full Analysis Set (FAS) consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter. Participants received either ethanol or placebo on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

Cmax is maximum observed plasma concentration at steady state of padsevonil.

Analysis of this outcome measure was not performed because the study was terminated. At that time, Part A had been completed, and 16 study participants had been treated with CBD in Treatment Period 1 of Part B.

Cmax is maximum observed plasma concentration at steady state of CBD.

Pharmacokinetic Set (PKS) included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

AUCtau is the area under the curve over a dosing interval of padsevonil.

Analysis of this outcome measure was not performed because the study was terminated. At that time, Part A had been completed, and 16 study participants had been treated with CBD in Treatment Period 1 of Part B.

AUCtau is the area under the curve over a dosing interval of CBD.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Continuous infusion of ethanol began with a 30 minute loading phase (prior to 0 hours) and was continued for 5 hours with adjustments during the infusion. Participants received either ethanol on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Continuous infusion of ethanol began with a 30 minute loading phase (prior to 0 hours) and was continued for 5 hours with adjustments during the infusion. Participants received either ethanol on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Cmax,ss is the maximum observed plasma concentration at steady state of padsevonil.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

AUC0-tau is the area under the curve over a dosing interval of padsevonil.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

t1/2 is the apparent terminal half-life of padsevonil.

Analysis of this outcome measure was not performed because the study was terminated. At that time, Part A had been completed, and 16 study participants had been treated with CBD in Treatment Period 1 of Part B.

t1/2 is the apparent terminal half-life of CBD.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

CLss/F is the apparent total body clearance at steady state following extravascular administration of padsevonil.

Analysis of this outcome measure was not performed because the study was terminated. At that time, Part A had been completed, and 16 study participants had been treated with CBD in Treatment Period 1 of Part B.

CLss/F is the apparent total body clearance at steady state following extravascular administration of CBD.

PKS included all study participants that received at least one dose of active study drug and have at least one observable pharmacokinetic measurement.

Smooth pursuit to assess eye movement coordination and attention to evaluate the ethanol effect. The average percentage of smooth pursuit for all stimulus frequencies was used as a parameter.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Sixteen saccades were recorded with interstimulus intervals varying randomly. Average values of latency (reaction time), saccadic peak velocity of all correct saccades, and inaccuracy of all saccades were used as parameters. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Sixteen saccades were recorded with interstimulus intervals varying randomly. Average values of latency (reaction time), saccadic peak velocity of all correct saccades, and inaccuracy of all saccades were used as parameters. Participants received either ethanol or placebo on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Sixteen saccades were recorded with interstimulus intervals varying randomly. Average values of latency (reaction time), saccadic peak velocity of all correct saccades, and inaccuracy of all saccades were used as parameters.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance. The average performance scores were used in the analysis. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance. The average performance scores were used in the analysis. Participants received either ethanol or placebo on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, Number of participants analyzed signifies participants who were evaluable for the assessment.

The adaptive tracking test was performed as originally described by Borland and Nicholson (Borland and Nicholson, 1984). Performance was scored after a fixed period of 3.5 minutes and reflected visuo-motor control and vigilance.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute. Participants received either ethanol or placebo on Day 1 of Period 1 or on Day 3 of Period 2. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, n (number analyzed) signifies participants evaluable at specified time points only.

Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute. Participants received either ethanol or placebo on Day 5 of Period 4 or Day 7 of Period 5. Therefore, the results were summarized by treatment.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation. Here, Number of participants analyzed signifies participants who were evaluable for the assessment and n (number analyzed) signifies participants evaluable at specified time points only.

Body Sway test measured the study participant's body movements in a single direction. Body sway was measured by CHCR NeuroCart. Study participants were asked to stand erect and motionless with their eyes closed. The amplitude and direction of any Body Sway was recorded for 1 minute.

FAS consisted of all study participants that were randomized, received study medication, and had at least one valid post-baseline primary pharmacodynamic assessment observation.

An adverse event (AE) was any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

An AE was any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

A SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

Treatment-related adverse event was an adverse event for which a causal relationship between the product and the occurrence is suspected.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Safety Set consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.