Patient-reported outcomes
migraine, fatigue pain, cloudiness, nausea, vomiting
MIGRAINE
All patient-reported outcomes were administered in the local language and validated in the language to which they were translated. The Patient Global Impression of Change (PGIC) instructs patients to rate their improvement due to treatment and uses a rating system with 7 categories of change (“very much improved”, “much improved”, “minimally improved”, “no change”, “minimally worse”, “much worse”, and “very much worse”). The lower the score, the greater the patient’s perceived improvement in their disease-related functioning [During the screening visit, investigators verbally asked patients for their patient-identified most bothersome symptom (PI-MBS) related to migraine, which was then categorized by the investigator into one of the following choices: nausea, vomiting, light sensitivity, sound sensitivity, mental cloudiness, fatigue pain with activity, mood changes, and “other/specify” (for alternative answers). Improvements were rated on a 7-point scale similar to that of PGIC, with lower scores indicating greater improvement in the most bothersome symptom [