Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

Safety population included all subjects who received at least 1 dose of IP. Subjects were analyzed according to the IP received.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine attacks (an episode of any qualified migraine headache. To distinguish an attack of long duration from two attacks or to distinguish between attacks and relapses:

A migraine attack that is interrupted by sleep, or temporarily remits, and then recurs within 48 hours (i.e., <48 hours between the start of the migraine attack to the time of the recurrence) will be considered as one attack and not two.

-An attack treated successfully with medication but with relapse within 48 hours (i.e., <48 hours between the start of the migraine attack to the time of recurrence) will be considered as one attack.)

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 112 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included use of rescue (acute migraine specific) medications and dosing administration.

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on headache days (a non-migraine headache day)

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

The Migraine Disability Assessment (MIDAS) questionnaire was administered to study examine the relationship between the impact of migraine and quality of life where subjects scored 5 questions on a scale of 0 to 21+ (0-5=little or no disability, 6-10=mild disability, 11-20=moderate disability, 21+=severe disability). The total score ranges from 0 to 90.

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

The Headache Impact Test-6 (HIT-6) questionnaire was administered to examine the relationship between impact of migraine and quality of life. The total score ranges from 36 to 78 where a higher score indicates a greater impact on quality of life (Class I: 36-49, Class II: 50-55, Class III: 56-59, Class IV: 60+).

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

The Migraine Specific Quality of Life (MSQL) questionnaire was used to examine the impact of migraine on health-related quality of life across three domains: Role Function-Restrictive (7 questions) examines the degree to which performance of daily activities is limited by migraine; Role Function-Preventive (4 questions) examines the degree to which performance of daily activities is prevented by migraine; Emotional Function (3 questions) examines feelings of frustration and helplessness due to migraine. Total score for each domain ranges from 0 to 100, where a higher score indicates greater severity.

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine associated symptoms: nausea/vomiting, photophobia and sonophobia.

Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 112 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.