***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Calcitonin gene-related peptide ( CGRP ) is a vali date d target for the treatment of episodic migraine . Here we assess the safety , tolerability , and efficacy of TEV-48125 , a monoclonal anti-CGRP antibody , in the preventive treatment of high-frequency episodic migraine . METHODS In this multicentre , r and omised , double-blind , placebo-controlled , phase 2b study , we enrolled men and women ( aged 18 - 65 years ) from 62 sites in the USA who had migraine headaches 8 - 14 days per month . Using a r and omisation list generated by a central computerised system and an interactive web response system , we r and omly assigned patients ( 1:1:1 ; stratified by sex and use of concomitant preventive drugs ) after a 28 day run-in period to three 28 day treatment cycles of subcutaneous 225 mg TEV-48125 , 675 mg TEV-48125 , or placebo . Investigators , patients , and the funder were blinded to treatment allocation . Patients reported headache information daily using an electronic diary . Primary endpoints were change from baseline in migraine days during the third treatment cycle ( weeks 9 - 12 ) and safety and tolerability . The secondary endpoint was change relative to baseline in headache-days during weeks 9 - 12 . Efficacy endpoints were analysed for the intention-to-treat population . Safety and tolerability were analysed using descriptive statistics . This trial is registered at Clinical Trials.gov , number NCT02025556 . FINDINGS Between Jan 8 , 2014 , and Oct 15 , 2014 , we enrolled 297 participants : 104 were r and omly assigned to receive placebo  , 95 to receive 225 mg TEV-48125 , and 96 to receive 675 mg TEV-48125 . The least square mean ( LSM ) change in number of migraine-days from baseline to weeks 9 - 12 was -3.46 days ( SD 5.40 ) in the placebo group , -6.27 days ( 5.38 ) in the 225 mg dose group , and -6.09 days ( 5.22 ) in the 675 mg dose group . The LSM difference in the reduction of migraine-days between the placebo and 225 mg dose groups was -2.81 days ( 95 % CI -4.07 to -1.55 ; p<0.0001 ) , whereas the difference between the placebo and 675 mg dose group was -2.64 days ( -3.90 to -1.38 ; p<0.0001 ) . LSM differences in the reduction of headache-days were -2.63 days ( -3.91 to -1.34 ; p<0.0001 ) between the placebo group and 225 mg dose group and -2.58 days ( -3.87 to 1.30 ; p < 0.0001 ) between the placebo group and the 675 mg dose group . Adverse events occurred in 58 ( 56 % ) patients in the placebo group , 44 ( 46 % ) patients in the 225 mg dose group , and 57 ( 59 % ) patients in the 675 mg dose group ; moderate or severe adverse events were reported for 29 ( 27 % ) patients , 24 ( 25 % ) patients , and 26 ( 27 % ) patients , respectively . INTERPRETATION TEV-48125 , at doses of 225 mg and 675 mg given once every 28 days for 12 weeks , was safe , well tolerated , and effective as a preventive treatment of high-frequency episodic migraine , thus supporting advancement of the clinical development programme to phase 3 clinical trials . FUNDING Teva Pharmaceuticals BACKGROUND Benefits of calcitonin-gene related peptide ( CGRP ) inhibition have not been established in chronic migraine . Here we assess the safety , tolerability , and efficacy of two doses of TEV-48125 , a monoclonal anti-CGRP antibody , in the preventive treatment of chronic migraine . METHODS In this multicentre , r and omised , double-blind , double-dummy , placebo-controlled , parallel-group phase 2b study , we enrolled men and women ( aged 18 - 65 years ) from 62 sites in the USA who had chronic migraine . Using a r and omisation list generated by a central computerised system and an interactive web response system , we r and omly assigned patients ( 1:1:1 , stratified by sex and use of concomitant preventive drugs ) to three 28-day treatment cycles of subcutaneous TEV-48125 675/225 mg ( 675 mg in the first treatment cycle and 225 mg in the second and third treatment cycles ) , TEV-48125 900 mg ( 900 mg in all three treatment cycles ) , or placebo . Investigators , patients , and the funder were blinded to treatment allocation . Daily headache information was captured using an electronic diary . Primary endpoints were change from baseline in the number of headache-hours during the third treatment cycle ( weeks 9 - 12 ) and safety and tolerability during the study . Secondary endpoint was change in the number of moderate or severe headache-days in weeks 9 - 12 relative to baseline . Efficacy endpoints were analysed for the intention-to-treat population . Safety and tolerability were analysed using descriptive statistics . This trial is registered with Clinical Trials.gov , number , NCT02021773 . FINDINGS Between Jan 8 , 2014 , and Aug 27 , 2014 , we enrolled 264 participants : 89 were r and omly assigned to receive placebo , 88 to receive 675/225 mg TEV-48125 , and 87 to receive 900 mg TEV-48125 . The mean change from baseline in number of headache-hours during weeks 9 - 12 was -59.84 h ( SD 80.38 ) in the 675/225 mg group and -67.51 h ( 79.37 ) in the 900 mg group , compared with -37.10 h ( 79.44 ) in the placebo group . The least square mean difference in the reduction of headache-hours between the placebo and 675/225 mg dose groups was -22.74 h ( 95 % CI -44.28 to -1.21 ; p=0.0386 ) , whereas the difference between placebo and 900 mg dose groups was -30.41 h ( -51.88 to -8.95 ; p=0.0057 ) . Adverse events were reported by 36 ( 40 % ) patients in the placebo group , 47 ( 53 % ) patients in the 675/225 mg dose group , and 41 ( 47 % ) patients in the 900 mg dose group , whereas treatment-related adverse events were recorded in 15 ( 17 % ) patients , 25 ( 29 % ) patients , and 28 ( 32 % ) patients , respectively . The most common adverse events were mild injection-site pain and pruritus . Four ( 1 % ) patients had serious non-treatment-related adverse events ( one patient in the placebo group , one patient in the 675/225 mg group , and two patients in the 900 mg group ) ; no treatment-related adverse events were serious and there were no relevant changes in blood pressure or other vital signs . INTERPRETATION TEV-48125 given by subcutaneous injection every 28 days seems to be tolerable and effective , thus supporting the further development of TEV-48125 for the preventive treatment of chronic migraine in a phase 3 trial . FUNDING Teva Pharmaceuticals Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology . Erenumab , a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor , is being evaluated for migraine prevention . Methods In this r and omized , double-blind , placebo-controlled , phase 3 study , 577 adults with episodic migraine were r and omized to placebo or 70 mg erenumab ; 570 patients were included in efficacy analyses . Primary endpoint was change in monthly migraine days . Secondary endpoints were ≥50 % reduction in monthly migraine days , change in acute migraine-specific medication treatment days , and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary . All endpoints assessed change from baseline at month 3 . Results Patients receiving erenumab experienced −2.9 days change in monthly migraine days , compared with −1.8 days for placebo , least-squares mean ( 95 % CI ) treatment difference of −1.0 ( −1.6 , −0.5 ) ( p < 0.001 ) . A ≥ 50 % reduction in monthly migraine days was achieved by 39.7 % ( erenumab ) and 29.5 % ( placebo ) of patients ( OR:1.59 ( 95 % CI : 1.12 , 2.27 ) ( p = 0.010 ) . Migraine-specific medication treatment days were reduced by −1.2 ( erenumab ) and −0.6 ( placebo ) days , a treatment difference of −0.6 ( −1.0 , −0.2 ) ( p = 0.002 ) . The ≥5-point reduction rates in Migraine Physical Function Impact Diary – Physical Impairment were 33.0 % and 27.1 % ( OR:1.33 ( 0.92 , 1.90 ) ( p = 0.13 ) and in Migraine Physical Function Impact Diary – Everyday Activities were 40.4 % and 35.8 % ( OR:1.22 ( 0.87 , 1.71 ) ( p = 0.26 ) . Safety and adverse event profiles of erenumab were similar to placebo . Most frequent adverse events were upper respiratory tract infection , injection site pain , and nasopharyngitis . Conclusions As a preventive treatment of episodic migraine , erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use . ( Funded by Amgen ) . Trial registration Clinical Trials.gov , NCT02483585 Importance Galcanezumab ( LY2951742 ) , a monoclonal antibody against calcitonin gene-related peptide ( CGRP ) , is one of a novel class of new medicines for migraine prevention . Objective To assess whether at least 1 dose of galcanezumab was superior to placebo for episodic migraine prevention . Design , Setting , and Participants A r and omized clinical trial was conducted in the United States ( July 7 , 2014 , to August 19 , 2015 ) in clinics of 37 licensed physicians with a specialty including , but not limited to , psychiatry , neurology , internal medicine , and primary care . Subcutaneous injections of galcanezumab , 5 , 50 , 120 , or 300 mg , or placebo were given monthly during the 3-month treatment period . A total of 936 patients were assessed ; 526 did not meet study entry or baseline criteria and 410 patients were r and omly assigned to receive placebo or galcanezumab .  Analyses were conducted on an intent-to-treat population , which included all patients who were r and omized and received at least 1 dose of study drug . Interventions Short-term migraine treatments were allowed as needed except for opioids or barbiturates . Main Outcomes and Measures To determine if at least 1 of the 4 doses of galcanezumab tested was superior to placebo for migraine prevention measured by the mean change from baseline in the number of migraine headache days 9 weeks to 12 weeks after r and omization . Results Of the 936 patients assessed , 410 met entry criteria ( aged 18 - 65 years with 4 - 14 migraine headache days per month and migraine onset prior to age 50 years ) and were r and omized to receive placebo or galcanezumab . For the primary end point , galcanezumab , 120 mg , significantly reduced migraine headache days compared with placebo ( 99.6 % posterior probability −4.8 days ; 90 % BCI , −5.4 to −4.2 days vs 95 % superiority threshold [ Bayesian analysis ] −3.7 days ; 90 % BCI , −4.1 to −3.2 days ) . Adverse events reported by 5 % or more of patients in at least 1 galcanezumab dose group and more frequently than placebo  included injection-site pain , upper respiratory tract infection , nasopharyngitis , dysmenorrhea , and nausea . Conclusions and Relevance Monthly subcutaneous injections of galcanezumab , both 120 mg and 300 mg , demonstrated efficacy ( repeated- measures analysis ) for the preventive treatment of migraine and support further development in larger phase 3 studies . All dosages were safe and well tolerated for the preventive treatment of episodic 
    Output:
    
The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine