{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3016-s0", "verdict_number": "3016", "title": "Medical-grade manuka honey × MGD dry-eye symptoms: added benefit over existing care unverified", "view_version": "1.0", "view_created_date": "2026-10-21", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Evaporative dry eye from meibomian gland dysfunction. Detailed diagnosis, severity, baseline status, eligibility and group composition remain unverified.", "intervention": "Medical-grade 16% manuka-honey drops or 98% gel were added to existing lid care. Formulations are distinguished from each other and from food-grade or nonsterile products.", "dose": "16% and 98% are concentrations of different formulations. Actual instilled amount, frequency, adherence and exposure remain unverified; concentration is not converted into administered dose.", "comparator": "Common warm compresses, lid massage and preservative-free lubricant in the 2017 trial are distinguished from comparison with regular lubricant in the 2021 trial. Details of matched group care and changes remain unverified.", "endpoint": "3-week SPEED symptoms are distinguished from selected staining and meibomian signs. Different within-group P values do not replace direct between-group symptom effects.", "duration": "The principal direct trial over 8 weeks is distinguished from the supporting symptom trial over 3 weeks. Long-term and post-stopping effects and harms remain unverified.", "excluded_extensions": [ "Selected C and absent individual score are distinguished from parent C46, selected-signs C and food-honey self-instillation F. Parent score or axes are not newly filled into the subquestion.", "16% drops and 98% gel are not combined, and medical-grade sterile products are not expanded into evidence for food-grade, nonsterile or homemade-dilution instillation.", "SPEED 2.53 points P=.006 and 1.087 points P=.183 are original within-group records. New differences, between-group superiority or CIs are not calculated.", "Selected staining P=.035, meibum quality P=.005 and gland expressibility P=.042 signals are not converted into patient symptom effects.", "114 participants and 59 randomized with 55 completed are distinguished without calculating new attrition counts, group, eye, patient or safety denominators, or incidence.", "Shared reports are not counted as new independent replication for each question. Short-term symptoms and signs are not expanded into long-term recovery, treatment replacement or overall safety." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which symptom question does this evidence check cover?", "needed": "Whether dry-eye symptoms improve more than with existing care and the scope of added benefit", "role": "Required", "role_reason": "Material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing subquestion is improved dry-eye symptoms over existing care. The original explanation that different within-group P values do not establish direct superiority is retained.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What is the hierarchy of SPEED and other symptom scales?", "needed": "The main symptom scale, version, time point, baseline and between-group results", "role": "Required", "role_reason": "Material on The main symptom scale, version, time point, baseline and between-group results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The main symptom scale, version, time point, baseline and between-group results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The supporting trial lists 3-week SPEED, tear film, inflammation and staining as outcomes. The principal trial covered multiple symptoms and signs.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was the SPEED change in the honey-drop group?", "needed": "The honey group's 3-week SPEED change, original analysis and denominator", "role": "Required", "role_reason": "Material on The honey group's 3-week SPEED change, original analysis and denominator is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The honey group's 3-week SPEED change, original analysis and denominator must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The supporting trial reported a within-group SPEED change of 2.53 points, P=.006, in the honey group. This is a before-and-after record in that group.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How is the regular-lubricant group's change distinguished?", "needed": "The regular-lubricant group's 3-week SPEED change and comparison conditions", "role": "Required", "role_reason": "Material on The regular-lubricant group's 3-week SPEED change and comparison conditions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The regular-lubricant group's 3-week SPEED change and comparison conditions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original control within-group change was 1.087 points, P=.183. Nonsignificance in control is not a test of honey-group superiority.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are P=.006 and P=.183 a between-group superiority test?", "needed": "Direct comparison of the changes, between-group P values and CIs", "role": "Required", "role_reason": "Material on Direct comparison of the changes, between-group P values and CIs is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Direct comparison of the changes, between-group P values and CIs must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original account explicitly states that the different within-group P values are not a superiority test.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the direct between-group symptom effect and 95% CI verified?", "needed": "The added symptom effect and its original uncertainty", "role": "Required", "role_reason": "Material on The added symptom effect and its original uncertainty is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The added symptom effect and its original uncertainty must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored summary records that the supporting trial's abstract did not present a direct between-group symptom effect.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Can overall improvement in 114 participants and 3 groups be assigned to the product?", "needed": "Added symptom benefit over common care and group-specific results", "role": "Required", "role_reason": "Material on Added symptom benefit over common care and group-specific results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Added symptom benefit over common care and group-specific results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "All groups in the principal trial improved and used common warm compresses, lid massage and preservative-free lubricant.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are 16% drops and 98% gel the same formulation?", "needed": "Formulation-specific symptom effects, administered amounts, frequency and control", "role": "Required", "role_reason": "Material on Formulation-specific symptom effects, administered amounts, frequency and control is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Formulation-specific symptom effects, administered amounts, frequency and control must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original record distinguishes 16% drops and 98% gel as different formulations.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are selected P values for clinical signs symptom effects?", "needed": "The direct relevance of staining and meibomian measures to symptom outcomes", "role": "Supplementary", "role_reason": "Material on The direct relevance of staining and meibomian measures to symptom outcomes is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The direct relevance of staining and meibomian measures to symptom outcomes must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "In the principal trial, staining with drops P=.035 and gel meibum quality P=.005 and gland expressibility P=.042 were signals in selected signs.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Does assessor masking also mean participant masking?", "needed": "The roles of assessor masking and symptom reporting and measurement", "role": "Required", "role_reason": "Material on The roles of assessor masking and symptom reporting and measurement is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The roles of assessor masking and symptom reporting and measurement must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The supporting trial's original design was an assessor-masked randomized trial.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the limitations of open treatment and multiple outcomes?", "needed": "The principal trial's open 3-group methods, prespecified symptom outcomes and all results", "role": "Required", "role_reason": "Material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The principal trial used an open 3-group randomized design and retained multiple symptoms and signs.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are 3 weeks and the principal 8 weeks the same duration?", "needed": "The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results", "role": "Required", "role_reason": "Material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The principal direct trial's 8 weeks and the supporting trial's 3-week SPEED measure are distinguished in the original account.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are symptom importance, responders and lubricant use verified?", "needed": "Direct material on SPEED importance, responders, lubricant and rescue-medication use", "role": "Supplementary", "role_reason": "Material on Direct material on SPEED importance, responders, lubricant and rescue-medication use is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Direct material on SPEED importance, responders, lubricant and rescue-medication use must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original outcome list includes symptoms and lubricant use, but prespecified importance, responders and exact between-group medication use are not detailed.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How are medical-grade sterile products distinguished from food honey?", "needed": "Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel", "role": "Required", "role_reason": "Material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original record concerns ophthalmic medical-grade products, not evidence for food-grade manuka honey or homemade dilution. Concentration differs from actual instilled amount and frequency.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What was added to common lid care?", "needed": "Warm compresses, massage, preservative-free lubricant and formulation-specific additional care", "role": "Required", "role_reason": "Material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "In 2017, all groups used common warm compresses, lid massage and preservative-free lubricant. The comparison added medical-grade honey products to that care.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are MGD diagnosis and sample size the same information?", "needed": "Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye", "role": "Required", "role_reason": "Material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The parent question concerns evaporative dry eye from meibomian gland dysfunction. 114 participants is the original sample-size label.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What are the symptom denominators in 114 participants and 3 groups?", "needed": "Group allocation, completion, analysis and endpoint-specific eye and patient denominators", "role": "Required", "role_reason": "Material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The principal trial's sample was 114 participants and its design was an open 3-group randomized trial.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What denominators are 59 randomized and 55 completed?", "needed": "Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators", "role": "Required", "role_reason": "Material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The supporting trial originally recorded 59 randomized and 55 completed. These values describe separate stages.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What is the impact of missingness, attrition and measurement exclusions?", "needed": "Group flow, missing symptom outcomes, analysis populations and sensitivity analyses", "role": "Required", "role_reason": "Material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Overall sample and completion records exist, but endpoint-specific missingness, attrition reasons and analysis conditions are not detailed.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What were the baseline adjustment, change and testing conditions?", "needed": "The effect of interest, baseline adjustment, change and final values, and variance", "role": "Required", "role_reason": "Material on The effect of interest, baseline adjustment, change and final values, and variance is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The effect of interest, baseline adjustment, change and final values, and variance must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Original P values and selected changes are retained, but detailed adjustment, variance, time points, denominators and effects of interest remain unread in external originals.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does a registration number also verify prespecified plans?", "needed": "Registration, history, primary outcomes, changes and original plans for both trials", "role": "Required", "role_reason": "Material on Registration, history, primary outcomes, changes and original plans for both trials is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Registration, history, primary outcomes, changes and original plans for both trials must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Registration was unverified for the principal trial, while NCT04457648 was recorded for the supporting trial.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Do parent and subquestions share the same reports?", "needed": "Report, trial and participant links between the symptom question and other questions", "role": "Required", "role_reason": "Material on Report, trial and participant links between the symptom question and other questions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Report, trial and participant links between the symptom question and other questions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The parent and subquestions share the same Albietz 2017 and Wong 2021 reports.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is independent replication across teams, products and formulations verified?", "needed": "Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point", "role": "Supplementary", "role_reason": "Material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The bibliographies of both reports retain an Albietz author and the specific Optimel product context.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How much is known about product provision and company involvement?", "needed": "Trial-specific funding, product support, employee authors and conflicts", "role": "Required", "role_reason": "Material on Trial-specific funding, product support, employee authors and conflicts is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Trial-specific funding, product support, employee authors and conflicts must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The principal trial records Optimel product provision and related involvement; the supporting trial records a specific Optimel product, provision and author conflict disclosure.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What is the scope of reported stinging and redness?", "needed": "Medical-grade product adverse reactions, collection methods, stopping and controls", "role": "Supplementary", "role_reason": "Material on Medical-grade product adverse reactions, collection methods, stopping and controls is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Medical-grade product adverse reactions, collection methods, stopping and controls must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original record reports temporary stinging and redness and cautions that initial symptoms are possible even with medical-grade formulations.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What are the eye and patient harm denominators and exposures?", "needed": "Safety populations, eyes, patients, formulations, durations and actual instillation exposure", "role": "Supplementary", "role_reason": "Material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "114 participants, 59 randomized and 55 completed do not verify safety denominators. Concentrations, formulations, 3 and 8 weeks and common care are not combined as the same harm exposure.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are food or nonsterile risks distinguished from medical-grade product reactions?", "needed": "Manufacture, sterility, baseline eye conditions, other causes and clinical course", "role": "Supplementary", "role_reason": "Material on Manufacture, sterility, baseline eye conditions, other causes and clinical course is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Manufacture, sterility, baseline eye conditions, other causes and clinical course must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original caution distinguishes infection and corneal-injury risks with food-grade, nonsterile and homemade dilutions from initial stinging and redness with medical-grade products.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are long-term, rare and vulnerable-population harms verified?", "needed": "Long exposure, independent harm reports, vulnerable populations and follow-up", "role": "Supplementary", "role_reason": "Material on Long exposure, independent harm reports, vulnerable populations and follow-up is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on Long exposure, independent harm reports, vulnerable populations and follow-up must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Small short-term trials of specific products and descriptions of temporary reactions do not verify long-term, rare or vulnerable-population safety.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How does stored-summary reading differ from reading external originals?", "needed": "The complete stored summary and the reading scope for external abstracts, full texts, registration and plans", "role": "Required", "role_reason": "Material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The complete parent Korean and English summary, reports and citations were read. PubMed URLs and registration numbers are existing records; external abstracts, full texts, registration, protocols and analysis plans were unread in this work.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What do selected C, parent C46, dates and empty values record?", "needed": "The selected grade, absent individual score, parent axes, evidence date and corrections", "role": "Required", "role_reason": "Material on The selected grade, absent individual score, parent axes, evidence date and corrections is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.", "application_exception": "Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.", "criterion": "Original material on The selected grade, absent individual score, parent axes, evidence date and corrections must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These are evidence conditions for the existing subquestion of improved dry-eye symptoms over existing care. They do not establish preregistration, execution of an official assessment tool or completed clinical content review.", "proposed_research": "Material needed: The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected grade is C, with no individual score, status or axes fields. Parent C46, caution, axes, Korean and English records, 2026-09-07 and empty correction and deliberation records are preserved separately.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events.", "uncertainty": "Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events." } ], "reports": [ { "report_id": "R01", "title": "Albietz JM·Lenton LM. 2017", "url": "https://pubmed.ncbi.nlm.nih.gov/28585260/", "report_type": "Open 3-group randomized trial", "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "The complete stored parent Korean and English summary, original reports and citations were read. External abstracts, full texts, registration, protocols and analysis plans were unread in this work.", "study_family": "Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.", "independent_replication": "Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.", "observed_result": "The original comparison in 114 participants added 16% drops or 98% gel to common care. All groups improved; selected sign signals included staining with drops P=.035 and gel meibum quality P=.005 and gland expressibility P=.042.", "result_level": "Selected formulation-specific signs are not converted into direct symptom superiority. The original principal duration is 8 weeks; group-specific symptom effects, precision, eye and patient denominators and prespecified hierarchy remain unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T13:02:14.255886+09:00", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28585260/" } ] }, { "report_id": "R02", "title": "Wong D et al. 2021", "url": "https://pubmed.ncbi.nlm.nih.gov/33419788/", "report_type": "Assessor-masked randomized trial", "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "The complete stored parent Korean and English summary, original reports and citations were read. External abstracts, full texts, registration, protocols and analysis plans were unread in this work.", "study_family": "Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.", "independent_replication": "Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.", "observed_result": "59 randomized and 55 completed were recorded, with 3-week within-group SPEED changes of 2.53 points P=.006 for honey drops and 1.087 points P=.183 for regular lubricant. The stored summary states that the abstract did not present a direct between-group symptom effect.", "result_level": "Different within-group P values are not a superiority test. Assessor masking is not promoted into participant or treatment-provider masking. New differences in changes, CIs, attrition counts or safety denominators are not calculated.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T13:02:14.255886+09:00", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33419788/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified." }, "history": [ { "date": "2026-10-21", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-21" }