{"id":"W3036624594","doi":"10.1186/s13023-020-01419-3","title":"Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)","year":2020,"lang":"en","type":"article","venue":"Orphanet Journal of Rare Diseases","topic":"Skin and Cellular Biology Research","field":"Biochemistry, Genetics and Molecular Biology","cited_by":22,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Galderma; Amryt Pharma; Mylan; Regeneron Pharmaceuticals; Amicus Therapeutics; Sanofi; Valeant Pharmaceuticals International; Celgene","keywords":"Medicine; Tolerability; Allantoin; Epidermolysis bullosa; Randomized controlled trial; Epidermolysis bullosa simplex; Confidence interval; Hazard ratio; Body surface area; Surgery; Dermatology; Internal medicine; Adverse effect","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0004321013,0.0001467833,0.0006482307,0.00004338495,0.00005636468,0.00002071582,0.0002547105,0.00007650151,0.00004325102],"category_scores_gemma":[0.001315471,0.00008303122,0.0001916702,0.000134772,0.0003450491,0.000009291805,0.00009417751,0.0001581252,3.516166e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000008198742,"about_ca_system_score_gemma":0.0002404201,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000009545399,"about_ca_topic_score_gemma":0.000005070258,"domain_scores_codex":[0.9979875,0.0006862936,0.0005923766,0.0002345062,0.0003467129,0.0001526238],"domain_scores_gemma":[0.9988148,0.0002437504,0.0003461296,0.0001794113,0.0002220835,0.0001938686],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9068492,0.002414238,0.08807144,0.00001854449,0.0003277893,0.00006409142,0.0000793803,0.00003474902,0.001845961,0.000008852867,0.00003875273,0.0002470137],"study_design_scores_gemma":[0.978099,0.003414691,0.01614165,0.00002951359,0.0002404888,0.00002589855,0.00006525349,0.00004364584,0.001788902,0.00003063567,0.00001721246,0.0001030847],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9969561,0.0007339495,0.0000258369,0.0005261967,0.00004945007,0.001675137,0.00002169247,0.000001666091,0.000009982672],"genre_scores_gemma":[0.9996108,0.00003790114,0.00002553868,0.00007340765,0.0001565747,0.00003960663,0.00003867573,0.000007525666,0.000009956011],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.07192979,"threshold_uncertainty_score":0.3385915,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0195088770734803,"score_gpt":0.285683329555379,"score_spread":0.2661744524818987,"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."}}