{"id":"W3157811570","doi":"10.1016/s2213-2600(21)00069-2","title":"Long-term safety of lumacaftor–ivacaftor in children aged 2–5 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a multicentre, phase 3, open-label, extension study","year":2021,"lang":"en","type":"letter","venue":"The Lancet Respiratory Medicine","topic":"Cystic Fibrosis Research Advances","field":"Medicine","cited_by":42,"is_retracted":false,"has_abstract":false,"ca_institutions":"Hospital for Sick Children; BC Children's Hospital; University of British Columbia","funders":"Cystic Fibrosis Foundation","keywords":"Ivacaftor; Cystic fibrosis; Medicine; Mutation; Open label; Term (time); Cystic fibrosis transmembrane conductance regulator; Internal medicine; Pediatrics; Adverse effect; Genetics; Biology; Gene","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002343233,0.0004015685,0.001239049,0.0001504321,0.0003689642,0.0007620971,0.0005847669,0.005690257,0.001823017],"category_scores_gemma":[0.007301323,0.0001973987,0.0010221,0.0002593288,0.0005237225,0.0005835137,0.0001789727,0.003274048,0.0006638542],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001130942,"about_ca_system_score_gemma":0.001041918,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001888778,"about_ca_topic_score_gemma":0.004637211,"domain_scores_codex":[0.998657,0.0006802164,0.000128086,0.0001488775,0.0002360956,0.0001497121],"domain_scores_gemma":[0.9945706,0.003445026,0.0007742292,0.0001213484,0.0005056069,0.000583291],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.1821005,0.002951463,0.07877736,0.002878592,0.00251237,0.01520801,0.0008625206,0.0009375006,0.01513856,0.001719486,0.2915104,0.4054034],"study_design_scores_gemma":[0.2440524,0.1173542,0.2654489,0.003400075,0.006968725,0.02208635,0.00147515,0.004052713,0.009748586,0.005350469,0.319724,0.0003384435],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.5160857,0.06597181,0.0009618115,0.3847476,0.01475317,0.0003694566,0.003779643,0.0001518542,0.013179],"genre_scores_gemma":[0.7352494,0.01106919,0.001092779,0.2333989,0.01091906,0.0003323593,0.0008929204,0.00003176371,0.007013636],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.005690257,"threshold_uncertainty_score":0.0123924,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0755477995268444,"score_gpt":0.3882117730929972,"score_spread":0.3126639735661528,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}