PMC:7507645 / 4396-5699 JSONTXT

{"project":"TEST0","denotations":[{"id":"32958075-237-243-1506671","span":{"begin":309,"end":311},"obj":"[\"29171818\"]"},{"id":"32958075-229-235-1506672","span":{"begin":765,"end":767},"obj":"[\"29171818\"]"},{"id":"32958075-228-234-1506673","span":{"begin":1299,"end":1301},"obj":"[\"29171818\"]"}],"text":"Study design, patients, and treatments\nA description of the randomized, double-blind, placebo-controlled, parallel-group phase 3 HALO CM study (NCT02621931), which included a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation (week 12), has been published previously [16].\nBriefly, adults aged 18 to 70 with a history of migraine (according to the International Classification of Headache Disorders, third edition [ICHD-3] beta criteria [17]) for ≥12 months prior to screening and prospectively confirmed CM (headache on ≥15 days and ≥8 days fulfilling ICHD-3 beta criteria for migraine, probable migraine, or use of triptan or ergot medications) during the 28-day pretreatment baseline period were eligible to participate [16]. Patients who used opioids (including codeine) or barbiturates on \u003e4 days per month were excluded from the trial. Additional inclusion and exclusion criteria are provided in a Table in Additional file 1.\nEligible patients were randomized 1:1:1 to receive subcutaneous injections of either fremanezumab quarterly (675 mg of fremanezumab at baseline and placebo at weeks 4 and 8), fremanezumab monthly (675 mg of fremanezumab at baseline and 225 mg at weeks 4 and 8), or placebo (matching placebo at baseline and at weeks 4 and 8) [16]."}

{"project":"2_test","denotations":[{"id":"32958075-29171818-60560878","span":{"begin":309,"end":311},"obj":"29171818"},{"id":"32958075-29171818-60560879","span":{"begin":765,"end":767},"obj":"29171818"},{"id":"32958075-29171818-60560880","span":{"begin":1299,"end":1301},"obj":"29171818"}],"text":"Study design, patients, and treatments\nA description of the randomized, double-blind, placebo-controlled, parallel-group phase 3 HALO CM study (NCT02621931), which included a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation (week 12), has been published previously [16].\nBriefly, adults aged 18 to 70 with a history of migraine (according to the International Classification of Headache Disorders, third edition [ICHD-3] beta criteria [17]) for ≥12 months prior to screening and prospectively confirmed CM (headache on ≥15 days and ≥8 days fulfilling ICHD-3 beta criteria for migraine, probable migraine, or use of triptan or ergot medications) during the 28-day pretreatment baseline period were eligible to participate [16]. Patients who used opioids (including codeine) or barbiturates on \u003e4 days per month were excluded from the trial. Additional inclusion and exclusion criteria are provided in a Table in Additional file 1.\nEligible patients were randomized 1:1:1 to receive subcutaneous injections of either fremanezumab quarterly (675 mg of fremanezumab at baseline and placebo at weeks 4 and 8), fremanezumab monthly (675 mg of fremanezumab at baseline and 225 mg at weeks 4 and 8), or placebo (matching placebo at baseline and at weeks 4 and 8) [16]."}