{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3003-s0", "verdict_number": "3003", "title": "Green-tea gargling × added laboratory-confirmed influenza prevention over water", "view_version": "1.0", "view_created_date": "2026-10-19", "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": "The trial randomized 757 Japanese high-school students and analyzed 747 in FAS. Original laboratory-confirmed denominators are 384 for green tea and 363 for water. Age range, schools/recruitment, baseline risk, eligibility/exclusions, arm allocation and analysis exclusions are unverified. Do not directly extend this to other ages or institutional populations.", "intervention": "An open randomized comparison of green-tea versus tap-water gargling. Products, catechin/constituents, concentration, volume, solution quality and actual delivery are unverified. Do not combine drinking, capsules, observational studies or other gargles as the same intervention or independent replication.", "dose": "Original study exposure is 3 times daily for 90 days; water controls also gargled. Constituent amounts, solutions, volume, actual exposure, adherence and stopping are unverified. Calculate no total exposure and create no personal gargling, infection-prevention or treatment instructions.", "comparator": "Tap-water gargling is the control; the question concerns added green-tea-constituent effects on top of gargling in both arms. The original text records control gargling 3 times daily. This is not a no-gargling comparator; matching procedures, volume, contact, delivery and adherence are unverified.", "endpoint": "The selection is added prevention of laboratory-confirmed influenza. Preserve green tea 19/384 versus water 25/363, adjusted OR 0.69 (95% CI 0.37 to 1.28), P=.24. PP OR 0.86 (0.44 to 1.69), P=.66 is a separate analysis with unverified denominators, interval level and criteria. Clinically defined HR is a separate subclaim record.", "duration": "The original trial spans 90 days; exact start/end, season, exposure, concurrent prevention, testing times and long-term follow-up are unverified. Do not extend this window into other seasons/populations, lasting effects, severe disease/hospitalization or treatment effects.", "excluded_extensions": [ "Turning added effects over water gargling into green-tea gargling versus no gargling", "Interchanging FAS/PP OR with clinically defined HR, intervals, denominators or hierarchy", "Turning wide intervals or null results into exact effect 0, equivalence, a new grade F or certain prevention", "Counting drinking, capsules, nursing-home observations, other gargles or verdict 720 as the same intervention or independent replication", "Transferring laboratory-confirmed results into clinically defined, severe-disease, treatment or other-population/period effects", "Using public funding, parent D with 34 points, Good safety or historical verification as subclaim scores or new independence/safety certification", "Creating new event rates, effects, CIs, totals, gargling procedures, infection-prevention or treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which added laboratory-confirmed prevention claim is selected?", "needed": "Selected claim, grade and note versus the parent verdict", "role": "Required", "role_reason": "This condition connects Selected claim, grade and note versus the parent verdict with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Selected claim, grade and note versus the parent verdict must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: The subclaim has no score, status or axes fields. Do not fill them with parent values. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The selection is added prevention of laboratory-confirmed influenza over water gargling. Preserve original grade D and the note that the OR 0.69 interval included 1. Parent D with 34 points is separate context.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The subclaim has no score, status or axes fields. Do not fill them with parent values.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The subclaim has no score, status or axes fields. Do not fill them with parent values." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which Japanese high-school students participated?", "needed": "Age, recruitment, schools, exposure, baseline risk and eligibility/exclusions", "role": "Required", "role_reason": "This condition connects Age, recruitment, schools, exposure, baseline risk and eligibility/exclusions with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Age, recruitment, schools, exposure, baseline risk and eligibility/exclusions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact age range, school/recruitment conditions, baseline infection risk, eligibility/exclusions and baseline characteristics are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original trial records 757 randomized Japanese high-school students and 747 in FAS.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact age range, school/recruitment conditions, baseline infection risk, eligibility/exclusions and baseline characteristics are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact age range, school/recruitment conditions, baseline infection risk, eligibility/exclusions and baseline characteristics are unverified." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What green-tea gargle was studied?", "needed": "Product, constituents, concentration, volume, quality and actual delivery", "role": "Required", "role_reason": "This condition connects Product, constituents, concentration, volume, quality and actual delivery with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Product, constituents, concentration, volume, quality and actual delivery must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Products, catechin/constituents, concentration, volume, actual delivery and solution-quality details are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Green-tea gargling 3 times daily for 90 days is original study exposure. Create no new gargling, infection-prevention or treatment instructions.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Products, catechin/constituents, concentration, volume, actual delivery and solution-quality details are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Products, catechin/constituents, concentration, volume, actual delivery and solution-quality details are unverified." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What are the water control and added effect?", "needed": "Gargling in both arms, control composition, procedures, contact and adherence", "role": "Required", "role_reason": "This condition connects Gargling in both arms, control composition, procedures, contact and adherence with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Gargling in both arms, control composition, procedures, contact and adherence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Matching solution procedures, volumes, delivery/contact and adherence records are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve the original green-tea/tap-water comparison and control water gargling 3 times daily. This was not a comparison against no gargling.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Matching solution procedures, volumes, delivery/contact and adherence records are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Matching solution procedures, volumes, delivery/contact and adherence records are unverified." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Were allocation and evaluation roles in the open trial verified?", "needed": "Random sequences, allocation concealment and tester/adjudicator/analyst blinding", "role": "Required", "role_reason": "This condition connects Random sequences, allocation concealment and tester/adjudicator/analyst blinding with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Random sequences, allocation concealment and tester/adjudicator/analyst blinding must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Allocation concealment, school/arm structures and tester/event-adjudicator/analyst blinding are unverified. An open design alone does not establish absent blinding for every role. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve Ide's original open randomized design.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Allocation concealment, school/arm structures and tester/event-adjudicator/analyst blinding are unverified. An open design alone does not establish absent blinding for every role.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation concealment, school/arm structures and tester/event-adjudicator/analyst blinding are unverified. An open design alone does not establish absent blinding for every role." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are randomization, FAS and testing denominators the same?", "needed": "Arm allocation, FAS definitions, exclusions, event assessment and missingness", "role": "Required", "role_reason": "This condition connects Arm allocation, FAS definitions, exclusions, event assessment and missingness with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Arm allocation, FAS definitions, exclusions, event assessment and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm randomization counts, exclusion reasons, FAS definitions and missing test data are unverified. Calculate no new attrition counts, rates or denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve 757 randomized, 747 FAS and laboratory-confirmed results of 19/384 versus 25/363.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Arm randomization counts, exclusion reasons, FAS definitions and missing test data are unverified. Calculate no new attrition counts, rates or denominators.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm randomization counts, exclusion reasons, FAS definitions and missing test data are unverified. Calculate no new attrition counts, rates or denominators." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How was laboratory-confirmed influenza defined?", "needed": "Tests, diagnostic thresholds, symptoms and collection/confirmation timing", "role": "Required", "role_reason": "This condition connects Tests, diagnostic thresholds, symptoms and collection/confirmation timing with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Tests, diagnostic thresholds, symptoms and collection/confirmation timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact test methods, thresholds, timing, collection/confirmation, symptom criteria and handling of untested cases are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The key endpoint is laboratory-confirmed influenza over 90 days.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact test methods, thresholds, timing, collection/confirmation, symptom criteria and handling of untested cases are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact test methods, thresholds, timing, collection/confirmation, symptom criteria and handling of untested cases are unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How are events and arm denominators assigned?", "needed": "Arm labels, event/person units, repeated/first events and test denominators", "role": "Required", "role_reason": "This condition connects Arm labels, event/person units, repeated/first events and test denominators with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Arm labels, event/person units, repeated/first events and test denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Repeated infections, first events and test-denominator definitions are unverified. Calculate no new risks, event rates, risk ratios or risk differences. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original record assigns laboratory-confirmed results to green tea 19/384 and water 25/363.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Repeated infections, first events and test-denominator definitions are unverified. Calculate no new risks, event rates, risk ratios or risk differences.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Repeated infections, first events and test-denominator definitions are unverified. Calculate no new risks, event rates, risk ratios or risk differences." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What are the adjusted OR, interval and P?", "needed": "Estimator, adjustment variables, model, denominators and interval/test relationships", "role": "Required", "role_reason": "This condition connects Estimator, adjustment variables, model, denominators and interval/test relationships with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Estimator, adjustment variables, model, denominators and interval/test relationships must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Adjustment variables, models, standard errors and original analysis outputs are unverified. Do not turn OR into a risk ratio or HR or create new estimates. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve adjusted OR 0.69 (95% CI 0.37 to 1.28), P=.24.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Adjustment variables, models, standard errors and original analysis outputs are unverified. Do not turn OR into a risk ratio or HR or create new estimates.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjustment variables, models, standard errors and original analysis outputs are unverified. Do not turn OR into a risk ratio or HR or create new estimates." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How are PP and FAS results distinguished?", "needed": "PP definitions, denominators, adherence, missingness, interval level and model", "role": "Required", "role_reason": "This condition connects PP definitions, denominators, adherence, missingness, interval level and model with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for PP definitions, denominators, adherence, missingness, interval level and model must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: PP arm denominators, adherence criteria, missing-data handling, interval level and models are unverified. Do not turn PP values into FAS or clinically defined HR. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original text records PP OR 0.86 (0.44 to 1.69), P=.66 and null FAS/PP results.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "PP arm denominators, adherence criteria, missing-data handling, interval level and models are unverified. Do not turn PP values into FAS or clinically defined HR.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PP arm denominators, adherence criteria, missing-data handling, interval level and models are unverified. Do not turn PP values into FAS or clinically defined HR." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Does a registration identifier verify prospective endpoints?", "needed": "Registration timing, endpoint hierarchy/changes, protocol and SAP", "role": "Required", "role_reason": "This condition connects Registration timing, endpoint hierarchy/changes, protocol and SAP with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Registration timing, endpoint hierarchy/changes, protocol and SAP must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registration timing, endpoint changes, protocols/SAPs and planned models are unread. Identifiers and historical descriptions do not establish a completed current prospective-status review. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original text describes failure of the central direct comparison, and original evidence records NCT01225770.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Registration timing, endpoint changes, protocols/SAPs and planned models are unread. Identifiers and historical descriptions do not establish a completed current prospective-status review.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration timing, endpoint changes, protocols/SAPs and planned models are unread. Identifiers and historical descriptions do not establish a completed current prospective-status review." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Were missingness, adherence and testing completeness verified?", "needed": "Suspected/untested infections, missed delivery and ITT/FAS/PP policies", "role": "Required", "role_reason": "This condition connects Suspected/untested infections, missed delivery and ITT/FAS/PP policies with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Suspected/untested infections, missed delivery and ITT/FAS/PP policies must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Missing tests, exclusions, adherence, observation completeness and sensitivity analyses are unverified. Do not fill in FAS as analysis of all randomized participants. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original text distinguishes FAS and PP results but provides no detailed policies.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Missing tests, exclusions, adherence, observation completeness and sensitivity analyses are unverified. Do not fill in FAS as analysis of all randomized participants.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Missing tests, exclusions, adherence, observation completeness and sensitivity analyses are unverified. Do not fill in FAS as analysis of all randomized participants." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were observation windows, exposure and concurrent prevention matched?", "needed": "Start/end, season, school environment, vaccination and shared exposure", "role": "Supplementary", "role_reason": "This condition connects Start/end, season, school environment, vaccination and shared exposure with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Start/end, season, school environment, vaccination and shared exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Season, exposure, school environment and arm matching of concurrent prevention/vaccination or other interventions are unverified. Provide no new prevention guidance. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve the original 90-day window and water-controlled scope.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Season, exposure, school environment and arm matching of concurrent prevention/vaccination or other interventions are unverified. Provide no new prevention guidance.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Season, exposure, school environment and arm matching of concurrent prevention/vaccination or other interventions are unverified. Provide no new prevention guidance." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are clinically defined HR and laboratory-confirmed OR the same?", "needed": "Diagnostic definitions, events/denominators, timing, models, hierarchy and estimators", "role": "Required", "role_reason": "This condition connects Diagnostic definitions, events/denominators, timing, models, hierarchy and estimators with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Diagnostic definitions, events/denominators, timing, models, hierarchy and estimators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Do not substitute HR values/intervals for laboratory-confirmed OR or identical denominators. Original links for definitions, analyses, hierarchy, time origins and interval types are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Distinguish the separate subclaim note's clinically defined HR 0.77 (0.53 to 1.11), P=.16 from laboratory-confirmed OR/PP.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Do not substitute HR values/intervals for laboratory-confirmed OR or identical denominators. Original links for definitions, analyses, hierarchy, time origins and interval types are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Do not substitute HR values/intervals for laboratory-confirmed OR or identical denominators. Original links for definitions, analyses, hierarchy, time origins and interval types are unverified." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How are wide intervals and null results interpreted?", "needed": "Planned comparisons, possible effect ranges and clinical importance", "role": "Required", "role_reason": "This condition connects Planned comparisons, possible effect ranges and clinical importance with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Planned comparisons, possible effect ranges and clinical importance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Clinical importance thresholds and sample planning are unverified. Create no new effects, CIs, absolute effects, equivalence, grade F or certain prevention. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The interval includes 1; the original text records possible benefit and some harm alongside no proof of complete null effects or equivalence.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Clinical importance thresholds and sample planning are unverified. Create no new effects, CIs, absolute effects, equivalence, grade F or certain prevention.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical importance thresholds and sample planning are unverified. Create no new effects, CIs, absolute effects, equivalence, grade F or certain prevention." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Can drinking, capsules or observations support this effect?", "needed": "Exposure routes, formulations, populations, designs and separate questions", "role": "Required", "role_reason": "This condition connects Exposure routes, formulations, populations, designs and separate questions with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Exposure routes, formulations, populations, designs and separate questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Do not transfer numbers from other routes, populations or designs into the selected added effect. Those materials were not newly read this run. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original text did not count green-tea drinking, capsules or nursing-home observations as replication of the gargling randomized trial.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Do not transfer numbers from other routes, populations or designs into the selected added effect. Those materials were not newly read this run.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Do not transfer numbers from other routes, populations or designs into the selected added effect. Those materials were not newly read this run." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is another gargling verdict the same intervention?", "needed": "Povidone-iodine/water versus the selected green-tea/water comparison", "role": "Required", "role_reason": "This condition connects Povidone-iodine/water versus the selected green-tea/water comparison with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Povidone-iodine/water versus the selected green-tea/water comparison must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Do not newly read 720 or combine it as replication in this sheet. Do not use other-gargle effects to strengthen this result. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original text records a different intervention in povidone-iodine/water gargling verdict 720.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Do not newly read 720 or combine it as replication in this sheet. Do not use other-gargle effects to strengthen this result.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Do not newly read 720 or combine it as replication in this sheet. Do not use other-gargle effects to strengthen this result." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Does this answer other populations, long-term, severe-disease or treatment effects?", "needed": "Age, season, duration, severe disease/hospitalization and treatment boundaries", "role": "Required", "role_reason": "This condition connects Age, season, duration, severe disease/hospitalization and treatment boundaries with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Age, season, duration, severe disease/hospitalization and treatment boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Other ages, seasons, lasting effects, severe disease/hospitalization and treatment effects are unverified. Do not transfer laboratory-confirmed prevention results into treatment effects. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The selection is a 90-day water-controlled added effect in high-school students.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Other ages, seasons, lasting effects, severe disease/hospitalization and treatment effects are unverified. Do not transfer laboratory-confirmed prevention results into treatment effects.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Other ages, seasons, lasting effects, severe disease/hospitalization and treatment effects are unverified. Do not transfer laboratory-confirmed prevention results into treatment effects." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can one report and two questions count as independent trials?", "needed": "Report, population, endpoint and sheet relationships and unique totals", "role": "Required", "role_reason": "This condition connects Report, population, endpoint and sheet relationships and unique totals with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Report, population, endpoint and sheet relationships and unique totals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Independent confirmation under the same conditions is unverified. Do not establish unique-trial, participant or independent-replication totals. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Laboratory-confirmed and clinically defined questions share the same Ide report. Do not count two endpoints or sheets as new trials or populations.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Independent confirmation under the same conditions is unverified. Do not establish unique-trial, participant or independent-replication totals.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent confirmation under the same conditions is unverified. Do not establish unique-trial, participant or independent-replication totals." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What were public funding, support and author roles?", "needed": "Financial/product/material support, employee authors, COI and analysis/publication roles", "role": "Required", "role_reason": "This condition connects Financial/product/material support, employee authors, COI and analysis/publication roles with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Financial/product/material support, employee authors, COI and analysis/publication roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Product/material support, employee authors, COI and design/analysis/publication roles are unverified. Funding information alone does not verify overall independence. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original evidence records public KAKENHI funding, described as a strength in the parent text.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Product/material support, employee authors, COI and design/analysis/publication roles are unverified. Funding information alone does not verify overall independence.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/material support, employee authors, COI and design/analysis/publication roles are unverified. Funding information alone does not verify overall independence." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does no reported adverse event establish safety?", "needed": "Original harm collection, arm events, denominators, missingness and stopping", "role": "Supplementary", "role_reason": "This condition connects Original harm collection, arm events, denominators, missingness and stopping with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Original harm collection, arm events, denominators, missingness and stopping must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Collection procedures, arm denominators, missingness/stopping and exact event counts are unverified. No reports do not become new safety certification or verified event counts. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve the wording that no adverse events were reported in the trial and parent Good safety status.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Collection procedures, arm denominators, missingness/stopping and exact event counts are unverified. No reports do not become new safety certification or verified event counts.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Collection procedures, arm denominators, missingness/stopping and exact event counts are unverified. No reports do not become new safety certification or verified event counts." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is this safe across ages, abilities and long-term exposures?", "needed": "Vulnerable populations, exposures, concurrent factors, alternative causes and follow-up", "role": "Supplementary", "role_reason": "This condition connects Vulnerable populations, exposures, concurrent factors, alternative causes and follow-up with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Vulnerable populations, exposures, concurrent factors, alternative causes and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Other ages, gargling abilities, exposures, long-term harms and alternative-cause data are unverified. Do not extend parent Good status into safety for everyone. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve original parent safety text and create no new gargling, infection-prevention or treatment instructions.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Other ages, gargling abilities, exposures, long-term harms and alternative-cause data are unverified. Do not extend parent Good status into safety for everyone.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Other ages, gargling abilities, exposures, long-term harms and alternative-cause data are unverified. Do not extend parent Good status into safety for everyone." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How are verdicts, both languages and dates preserved?", "needed": "Parent/subclaim original values, axes, empty histories and evidence date", "role": "Required", "role_reason": "This condition connects Parent/subclaim original values, axes, empty histories and evidence date with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Parent/subclaim original values, axes, empty histories and evidence date must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Historical cross-checks and strengths of direct trials do not become current review, satisfied conditions or subclaim scores. Distinguish production from evidence dates. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve parent D with 34 points, original bilingual texts, axes, 2026-09-07, empty correction/deliberation records and subclaim D/note with absent score/status/axes.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Historical cross-checks and strengths of direct trials do not become current review, satisfied conditions or subclaim scores. Distinguish production from evidence dates.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical cross-checks and strengths of direct trials do not become current review, satisfied conditions or subclaim scores. Distinguish production from evidence dates." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Stored summaries, bibliography, external papers, registration, plans and support", "role": "Required", "role_reason": "This condition connects Stored summaries, bibliography, external papers, registration, plans and support with added green-tea effects over water gargling, laboratory-confirmed versus clinically defined outcomes, events, denominators, FAS/PP, OR/HR, precision and harm boundaries.", "application_exception": "Preserve selected D and its null OR-interval note. Distinguish absent subclaim score/status/axes from parent D with 34 points. Water controls do not become no-gargling controls; OR, PP and clinical HR do not become the same analysis. Create no new effects, rates, CIs, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Stored summaries, bibliography, external papers, registration, plans and support must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: External papers, registration, protocols/SAPs and support originals are unread and access was not attempted. URLs/historical verification do not become current reading or link checks. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Production used complete stored summaries and bibliography. Distinguish summary reading, unread external materials and source links.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "External papers, registration, protocols/SAPs and support originals are unread and access was not attempted. URLs/historical verification do not become current reading or link checks.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External papers, registration, protocols/SAPs and support originals are unread and access was not attempted. URLs/historical verification do not become current reading or link checks." } ], "reports": [ { "report_id": "S01", "title": "Ide K, Yamada H, Matsushita K, et al. Effects of Green Tea Gargling on the Prevention of Influenza Infection in High School Students: A Randomized Controlled Study. PLoS One. 2014;9:e96373. PMID: 24836780. PMCID: PMC4023996. DOI: 10.1371/journal.pone.0096373.", "url": "https://pubmed.ncbi.nlm.nih.gov/24836780/", "report_type": "Open randomized green-tea versus tap-water trial", "existence": "Report linked in the original parent stored summary evidence/citation lists. External public availability, access and current acquisition of the original are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "study_family": "Same Ide report; unique counts and independent replication unverified", "independent_replication": "Laboratory-confirmed and clinically defined questions share the same Ide report and population. Do not count different endpoints, analysis populations or sheets as new independent trials or participant totals. Independent confirmation under the same conditions and unique-trial/participant totals are unverified.", "observed_result": "19/384 vs 25/363; OR 0.69 (0.37 to 1.28), P=.24", "result_level": "Laboratory-confirmed results from 757 randomized, 747 FAS participants over 90 days of green-tea versus water gargling. Preserve green tea 19/384, water 25/363 and adjusted OR 0.69 (95% CI 0.37 to 1.28), P=.24. Denominators and interval level for PP OR 0.86 (0.44 to 1.69), P=.66 are unverified. Distinguish clinically defined HR and no-gargling comparisons; calculate no new event rates or effects.", "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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." }, { "material_type": "External paper", "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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." }, { "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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." }, { "material_type": "Protocol", "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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." }, { "material_type": "Statistical 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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." }, { "material_type": "Funding, product-support and COI 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": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 24836780, PMCID PMC4023996 and DOI 10.1371/journal.pone.0096373. Original evidence registration wording is NCT01225770; a separate registration annotation is unrecorded for this case. Identifiers/PMCID do not establish registration/full-text reading or prospective verification; infer no new URLs." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/24836780/" } ] } ], "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": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Laboratory-confirmed and clinically defined questions share the same Ide report and population. Do not count different endpoints, analysis populations or sheets as new independent trials or participant totals. Independent confirmation under the same conditions and unique-trial/participant totals are unverified." }, "history": [ { "date": "2026-10-19", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 24 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-19" }