{"id":"W3119449695","doi":"10.1136/bmjopen-2020-041479","title":"Study protocol of RESCUE-ALS: A Phase 2, randomised, double-blind, placebo-controlled study in early symptomatic amyotrophic lateral sclerosis patients to assess bioenergetic catalysis with CNM-Au8 as a mechanism to slow disease progression","year":2021,"lang":"en","type":"article","venue":"BMJ Open","topic":"Amyotrophic Lateral Sclerosis Research","field":"Medicine","cited_by":51,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"FightMND; National Health and Medical Research Council; ALS Association; Johns Hopkins University; Emory University; Montreal Neurological Institute and Hospital; Massachusetts General Hospital; Western Sydney Local Health District; Thomas Jefferson University","keywords":"Medicine; Amyotrophic lateral sclerosis; Riluzole; Placebo; Teriflunomide; Clinical endpoint; Pharmacokinetics; Clinical trial; Pharmacology; Internal medicine; Multiple sclerosis; Disease; Fingolimod; Pathology; Immunology","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.002560504,0.0006368305,0.002352749,0.0007706936,0.0002026188,0.0004837252,0.0009882145,0.0001225235,0.0002385229],"category_scores_gemma":[0.0009408108,0.0004262694,0.0002460454,0.002265697,0.00006124494,0.0004881185,0.001552238,0.0003924014,0.00008621481],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0003884481,"about_ca_system_score_gemma":0.001209033,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0014682,"about_ca_topic_score_gemma":0.000730923,"domain_scores_codex":[0.9915053,0.001689176,0.001787263,0.001391919,0.002726388,0.0008999267],"domain_scores_gemma":[0.9953482,0.0001873424,0.000428429,0.001783778,0.001022097,0.001230156],"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":[0.8333553,0.03137877,0.1235486,0.000388386,0.0009555781,0.001171808,0.0033602,0.000166456,0.004534917,0.000004806524,0.00006527011,0.00106993],"study_design_scores_gemma":[0.795768,0.01882017,0.17746,0.003324943,0.0007720541,0.000006200212,0.0007702598,0.0003862882,0.002105893,0.0000170878,0.000004304114,0.0005647654],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.580885,0.000002032711,0.00001525646,0.0004263245,0.00002754924,0.4185459,0.0000110822,0.00003241282,0.0000544924],"genre_scores_gemma":[0.55517,4.605841e-7,0.0003882469,0.0001028959,0.00003278943,0.4437788,0.00002708164,0.00006848034,0.0004312192],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.05391144,"threshold_uncertainty_score":0.9998189,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1321636561468989,"score_gpt":0.4573727062569956,"score_spread":0.3252090501100967,"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."}}