{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001244855,0.0007900414,0.001792251,0.0002251639,0.0002518196,0.0007228329,0.0005751408,0.000896331,0.003466904],"category_scores_gemma":[0.0009264016,0.0004011826,0.001565903,0.0002651284,0.0005958442,0.0006703588,0.0002321134,0.001589683,0.0004904397],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004705891,"about_ca_system_score_gemma":0.0009137452,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0005570353,"about_ca_topic_score_gemma":0.00130155,"domain_scores_codex":[0.9996716,0.0001575233,0.00002892908,0.00005494133,0.00003554451,0.00005152275],"domain_scores_gemma":[0.9993993,0.0001611847,0.0001765348,0.00004202436,0.00004979971,0.0001711399],"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":[0.9303468,0.01652149,0.002887775,0.001428769,0.001254341,0.00009743471,0.0001155298,0.0004493528,0.0102943,0.0001023411,0.0009621684,0.03553975],"study_design_scores_gemma":[0.8340302,0.1563057,0.007131283,0.00004488668,0.000488256,0.00008635211,0.00003863548,0.0004315251,0.0007124974,0.00005951166,0.0006553351,0.00001576795],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9937535,0.003507765,0.0002656762,0.000183197,0.0001145105,0.0009950929,0.0003670937,0.00003941494,0.0007737783],"genre_scores_gemma":[0.994504,0.002091795,0.0005490849,0.0004207295,0.0001426214,0.001005507,0.0004805643,0.000008727483,0.0007970124],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.003466904,"threshold_uncertainty_score":0.01159793,"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."}}