The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of participants with any adverse event was categorized by race. The category "Other" captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet

The number of participants with adverse events by gender is recorded.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet

The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

BMI = (Weight in kilograms)/(height in centimeters/100)^2

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

A sitting heart rate was measured once for each participant at each visit.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.

Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.

Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.

ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.

ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.

ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment

The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet

The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.

The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from "very satisfied" (1) to "very dissatisfied" (7).

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.

The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from "very satisfied" (1) to "very dissatisfied" (7).

Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.