{"id":"ca3c0db9-68c0-57a6-b024-64a9395b1412","stable_key":"cfa4bd86-d88d-555a-975c-68877bf00e0f:lutein-areds-primary-null","predicate":"does_not_significantly_reduce_in_primary_analysis","statement":"Primary L+Z versus placebo comparison gave HR 0.90 (98.7% CI 0.76–1.07; P=0.12).","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"d971e6f8-1a73-5521-a028-8e005dab4955","mechanism_event_label":"Adding the pair did not meet the primary statistical threshold.","subject":{"id":"23b4e9a5-0e3d-578b-aff7-100c6a8ac3e7","slug":"areds2-lz-addition","display_name":"AREDS2 lutein/zeaxanthin addition to background AREDS formulation","entity_type_key":"chemical_species"},"object":{"id":"39040b3b-1179-517e-8047-d32ae991ad03","slug":"human-late-amd-progression","display_name":"Progression to late age-related macular degeneration","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"d971e6f8-1a73-5521-a028-8e005dab4955","stable_key":"cfa4bd86-d88d-555a-975c-68877bf00e0f:lutein-areds-primary-null-event","event_type":"observed_intervention","label":"Adding the pair did not meet the primary statistical threshold.","description":"Primary L+Z versus placebo comparison gave HR 0.90 (98.7% CI 0.76–1.07; P=0.12).","status":"provisional","compartment":null,"participants":[{"entity":{"id":"5dd84367-3f8e-5a3f-b952-a96174ea51fa","slug":"lutein","display_name":"Lutein","entity_type_key":"small_molecule"},"role":"combination_component","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"0a60c685-7502-5ece-9da2-2c1a2e3bcdf1","slug":"zeaxanthin","display_name":"Dietary (3R,3-prime-R)-zeaxanthin","entity_type_key":"small_molecule"},"role":"combination_component","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"da1a7137-08f2-5a36-8bb6-377fbd32e327","slug":"vitamin-c","display_name":"Vitamin C","entity_type_key":"chemical_species"},"role":"background_formula","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""},{"entity":{"id":"e67a0437-6900-5f53-8b03-c0a7ad6d92b6","slug":"vitamin-e","display_name":"Vitamin E","entity_type_key":"chemical_species"},"role":"background_formula","stoichiometry":null,"state_label":"","sequence_order":3,"notes":""},{"entity":{"id":"0429f0ff-c033-514b-9a4f-6f0f83268095","slug":"zinc","display_name":"Zinc","entity_type_key":"nutrient_element"},"role":"background_formula","stoichiometry":null,"state_label":"","sequence_order":4,"notes":""},{"entity":{"id":"23b4e9a5-0e3d-578b-aff7-100c6a8ac3e7","slug":"areds2-lz-addition","display_name":"AREDS2 lutein/zeaxanthin addition to background AREDS formulation","entity_type_key":"chemical_species"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":5,"notes":""},{"entity":{"id":"39040b3b-1179-517e-8047-d32ae991ad03","slug":"human-late-amd-progression","display_name":"Progression to late age-related macular degeneration","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":6,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/lutein-research/23644932.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1bd379926e56d7243222c2ef69d6367b74aede2b02faabfb77fadcbadf95008f\", \"start_char\": 0, \"end_char\": 3037, \"text_sha256\": \"1bd379926e56d7243222c2ef69d6367b74aede2b02faabfb77fadcbadf95008f\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"AREDS2 phase 3 factorial randomized trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Lutein 10 mg + zeaxanthin 2 mg daily; background AREDS formula; median five years","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Combination and background treatment prevent attribution to lutein alone; primary contrast differs from replacement and main-effects analyses. 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Published correction 10.1001/jama.2013.6403 changes the Table 3 lung-neoplasm row label and Table 4 lung-neoplasm entries. These records use the indexed abstract and do not reproduce the uncorrected Table 4. Correction: https://jamanetwork.com/journals/jama/fullarticle/1710434 .\nexposure: Lutein 10 mg + zeaxanthin 2 mg daily; background AREDS formula; median five years\nevidence_span: {\"source_cache\": \"artifacts/lutein-research/23644932.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1bd379926e56d7243222c2ef69d6367b74aede2b02faabfb77fadcbadf95008f\", \"start_char\": 0, \"end_char\": 3037, \"text_sha256\": \"1bd379926e56d7243222c2ef69d6367b74aede2b02faabfb77fadcbadf95008f\"}\n[lutein-p23644932] Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. 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