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Psoriasis was assessed by Physician Global Assessment PGAA) for psoriasis (a 7-point scale ranging from "clear" to "severe"), 8 target lesion assessment (total plaque score 0 15, not assessed at week 2) requiring a lesion of ⩾2 cm in the greatest diameter at baseline, 8 Nail Psoriasis Severity Index (NAPSI; 0 80, only of the hands), 9 and the Dermatology Life Quality Index (DLQI; score of 0 30).
The primary efficacy assessment was the mean change from baseline assessed at week 8 in total IDS-C30 score for adjunctive armodafinil 150 mg/day versus adjunctive placebo as analyzed by mixed-model repeated measures (MMRM).
Radiological response of the reference tumour lesion and overall radiological response were assessed at week 12. Serum pharmacokinetic and biomarker analyses were also performed.
Radiological response of the reference tumour lesion and overall radiological response were assessed at week 12 using Response Evaluation Criteria in Solid Tumors (RECIST) [21].
Patients: Of 157 patients recruited 24 ± 14 weeks after single-incident brain injury, 142 patients were assessed at week 12, and 128 patients at follow-up.
Primary and secondary endpoints were assessed at Week 12. Exploratory endpoints included: change from baseline in migraine-specific quality of life (QoL) measured by the Migraine-Specific QoL Questionnaire (MSQ), headache impact measured by the Headache Impact Test (HIT-6), and migraine-related disability measured by the Migraine Disability Assessment Test (MIDAS).
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Patients were assessed at weeks 0, 2, 4 and 8 with the Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS) and Clinical Global Impression of Severity (CGI-S).
Immune responses were assessed at weeks 0 (before injection), 2, 6, 14 and 24.
Anthropometric measures and aerobic fitness were assessed at week-1.
After randomization (week 0), patients were assessed at weeks 4, 8, 12, 16, 20, and 24.
Efficacy and safety were assessed at weeks 2, 4, 8, and 12.
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