{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3003-s1", "verdict_number": "3003", "title": "Green-tea gargling × prevention of clinically defined influenza", "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 parent trial records 757 randomized Japanese high-school students and 747 in FAS. This is trial context; arm denominators, events/observation time, eligibility and baseline risk for clinical HR are unlinked. Do not automatically transfer laboratory-confirmed denominators to the clinical outcome.", "intervention": "Preserve the parent green-tea versus tap-water gargling trial context. Products, constituents, concentration, volume, actual delivery and adherence linked to the clinical outcome are unverified. Do not combine drinking, capsules, observational material or other gargles as the same exposure or independent replication, or create new instructions.", "dose": "Parent exposure is green-tea/water gargling 3 times daily for 90 days. Do not newly establish quantitative exposure, adherence or an observation window for clinical HR from this context. Calculate no total exposure and create no personal gargling, infection-prevention or treatment instructions.", "comparator": "The parent Ide trial compares green tea with tap water; water controls also gargled 3 times daily. Preserve the selected clinically defined question, while original arm mapping and comparator details for clinical HR remain unlinked. Do not turn this into a no-gargling control trial.", "endpoint": "The selected subclaim note records clinically defined influenza HR 0.77 (0.53 to 1.11), P=.16 as null. Clinical definitions, events, denominators, interval type/level, adjustment, model, censoring, hierarchy and original table attribution are unlinked. Distinguish parent laboratory-confirmed OR/FAS/PP and the 95% CI label.", "duration": "The parent 90 days is trial context. Exact time origin, risk sets, censoring and observation window for clinical HR are unlinked. Do not extend this into verified long-term, other-age, severe-disease/hospitalization, reinfection or treatment effects.", "excluded_extensions": [ "Transferring laboratory-confirmed events, denominators, OR/FAS/PP, interval level or adjustment to clinical HR", "Newly verifying clinical definitions, time origin, censoring, hierarchy or table attribution, or promoting the endpoint to primary", "Turning clinical null findings into exact effect 0, equivalence, certain prevention or a new grade F", "Counting the two questions or populations from the same Ide report as new independent trials or participant totals", "Combining drinking, capsules, observations, other gargles or verdict 720 as replication of the same clinical HR", "Inheriting public funding, parent D with 34 points, Good safety or historical verification as subclaim scores or new independence/safety certification", "Creating new events, rates, effects, intervals, totals or gargling, infection-prevention or treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which clinically defined influenza claim is selected?", "needed": "Selected question, grade, note and parent laboratory-confirmed context", "role": "Required", "role_reason": "This condition connects Selected question, grade, note and parent laboratory-confirmed context with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Selected question, grade, note and parent laboratory-confirmed context 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: Subclaim score, status and axes fields are absent. Do not fill them from parent values or replace this with the laboratory-confirmed endpoint. 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 prevention of clinically defined influenza; preserve subclaim D and the null note HR 0.77 (0.53 to 1.11), P=.16. Parent D with 34 points is separate laboratory-confirmed 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": "Subclaim score, status and axes fields are absent. Do not fill them from parent values or replace this with the laboratory-confirmed endpoint.", "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": "Subclaim score, status and axes fields are absent. Do not fill them from parent values or replace this with the laboratory-confirmed endpoint." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How was clinically defined influenza defined?", "needed": "Symptoms, fever/care, case definition and evaluation/adjudication procedures", "role": "Required", "role_reason": "This condition connects Symptoms, fever/care, case definition and evaluation/adjudication procedures with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Symptoms, fever/care, case definition and evaluation/adjudication procedures 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 clinical case criteria, reporting/care, assessors and distinction from other respiratory diseases are unlinked. 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 selected note records clinical HR, distinguished from the parent evidence's laboratory-confirmed endpoint.", "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": "Exact clinical case criteria, reporting/care, assessors and distinction from other respiratory diseases are unlinked.", "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 clinical case criteria, reporting/care, assessors and distinction from other respiratory diseases are unlinked." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the water-control trial context?", "needed": "Comparator, arms and added-effect scope linked to the clinical question", "role": "Required", "role_reason": "This condition connects Comparator, arms and added-effect scope linked to the clinical question with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Comparator, arms and added-effect scope linked to the clinical question 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 mapping, comparator conditions and definitions in the original clinical HR table are unlinked. A shared bibliographic link does not become new table verification. 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 parent Ide trial compares green tea with tap water; water controls also gargled 3 times daily. Preserve the selected wording and do not create a no-gargling 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": "Arm mapping, comparator conditions and definitions in the original clinical HR table are unlinked. A shared bibliographic link does not become new table verification.", "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 mapping, comparator conditions and definitions in the original clinical HR table are unlinked. A shared bibliographic link does not become new table verification." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are parent trial participants and clinical denominators the same?", "needed": "Eligibility, baseline risk and clinical-outcome denominators", "role": "Required", "role_reason": "This condition connects Eligibility, baseline risk and clinical-outcome denominators with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Eligibility, baseline risk and clinical-outcome 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: Analysis populations, arm denominators, age/eligibility and baseline clinical risk for HR are unlinked. Do not automatically transfer laboratory-confirmed denominators 384/363. 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 parent 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": "Analysis populations, arm denominators, age/eligibility and baseline clinical risk for HR are unlinked. Do not automatically transfer laboratory-confirmed denominators 384/363.", "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": "Analysis populations, arm denominators, age/eligibility and baseline clinical risk for HR are unlinked. Do not automatically transfer laboratory-confirmed denominators 384/363." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which gargle formulation and exposure were recorded?", "needed": "Products, constituents, concentration, volume, delivery and arm-specific adherence", "role": "Required", "role_reason": "This condition connects Products, constituents, concentration, volume, delivery and arm-specific adherence with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Products, constituents, concentration, volume, delivery and arm-specific 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: Formulation, concentration, actual exposure, delivery adherence and cross-exposure linked to the clinical outcome 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": "Parent exposure is green-tea/water gargling 3 times daily for 90 days. Preserve the research record without creating new gargling or prevention 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": "Formulation, concentration, actual exposure, delivery adherence and cross-exposure linked to the clinical outcome 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": "Formulation, concentration, actual exposure, delivery adherence and cross-exposure linked to the clinical outcome are unverified." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Were open allocation and clinical-assessment biases verified?", "needed": "Allocation, concealment, reporting/adjudication and analysis blinding", "role": "Required", "role_reason": "This condition connects Allocation, concealment, reporting/adjudication and analysis blinding with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Allocation, concealment, reporting/adjudication and analysis 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: Details of blinding in clinical symptom reporting, care selection, event adjudication and analysis are unlinked. Laboratory-endpoint structures do not replace clinical assessment. 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 parent trial is recorded as an 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": "Details of blinding in clinical symptom reporting, care selection, event adjudication and analysis are unlinked. Laboratory-endpoint structures do not replace clinical assessment.", "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": "Details of blinding in clinical symptom reporting, care selection, event adjudication and analysis are unlinked. Laboratory-endpoint structures do not replace clinical assessment." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Where are HR, interval and P recorded?", "needed": "Selected note, estimator, arm direction, interval level and analysis", "role": "Required", "role_reason": "This condition connects Selected note, estimator, arm direction, interval level and analysis with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Selected note, estimator, arm direction, interval level and analysis 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 mapping, adjustment, model and interval type/level are absent from the note. Do not automatically attach the parent laboratory OR's 95% CI label or adjustment. 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": "HR 0.77 (0.53 to 1.11), P=.16 comes from the selected clinically defined subclaim note.", "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 mapping, adjustment, model and interval type/level are absent from the note. Do not automatically attach the parent laboratory OR's 95% CI label or adjustment.", "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 mapping, adjustment, model and interval type/level are absent from the note. Do not automatically attach the parent laboratory OR's 95% CI label or adjustment." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Were HR time origin, risk sets and censoring verified?", "needed": "Follow-up window, events/person-time, time origin, censoring and model assumptions", "role": "Required", "role_reason": "This condition connects Follow-up window, events/person-time, time origin, censoring and model assumptions with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Follow-up window, events/person-time, time origin, censoring and model assumptions 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 HR time origin, censoring/risk sets, recurrent/first events and model assumptions are unlinked. Do not convert HR into cumulative risk or OR. 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 parent trial's 90 days as research context, distinguished from the clinical HR observation window.", "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": "Clinical HR time origin, censoring/risk sets, recurrent/first events and model assumptions are unlinked. Do not convert HR into cumulative risk or OR.", "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 HR time origin, censoring/risk sets, recurrent/first events and model assumptions are unlinked. Do not convert HR into cumulative risk or OR." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What are clinical event counts and arm denominators?", "needed": "Clinically defined patients/events, recurrence and assessment denominators", "role": "Required", "role_reason": "This condition connects Clinically defined patients/events, recurrence and assessment denominators with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Clinically defined patients/events, recurrence and assessment 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: Clinical events, patients, arm denominators and observation time cannot be replaced by laboratory-confirmed 19/25 or 384/363. Calculate no new events, rates or 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 selected note contains only HR, interval and P; it provides no clinical event counts.", "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": "Clinical events, patients, arm denominators and observation time cannot be replaced by laboratory-confirmed 19/25 or 384/363. Calculate no new events, rates or 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": "Clinical events, patients, arm denominators and observation time cannot be replaced by laboratory-confirmed 19/25 or 384/363. Calculate no new events, rates or effects." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Were the clinical analysis population and missingness verified?", "needed": "FAS/PP/ITT, symptom/care missingness, exclusions and sensitivity", "role": "Required", "role_reason": "This condition connects FAS/PP/ITT, symptom/care missingness, exclusions and sensitivity with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for FAS/PP/ITT, symptom/care missingness, exclusions and sensitivity 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 HR analysis populations, missingness/exclusions, adherence/PP and sensitivity are unlinked. Do not transfer laboratory-confirmed PP to clinical PP. 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": "Parent FAS of 747 and PP OR 0.86 (0.44 to 1.69), P=.66 remain laboratory-confirmed analysis context.", "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": "Clinical HR analysis populations, missingness/exclusions, adherence/PP and sensitivity are unlinked. Do not transfer laboratory-confirmed PP to clinical PP.", "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 HR analysis populations, missingness/exclusions, adherence/PP and sensitivity are unlinked. Do not transfer laboratory-confirmed PP to clinical PP." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were clinical endpoint hierarchy, multiplicity and registration verified?", "needed": "Prespecified primary/secondary designation, changes and testing plan", "role": "Required", "role_reason": "This condition connects Prespecified primary/secondary designation, changes and testing plan with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Prespecified primary/secondary designation, changes and testing plan 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 hierarchy, multiplicity, changes and original registration/protocol/SAP are unread. Do not promote clinical HR to a new primary endpoint. 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 registration wording is NCT01225770; the parent's primary comparison is laboratory-confirmed context.", "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": "Clinical hierarchy, multiplicity, changes and original registration/protocol/SAP are unread. Do not promote clinical HR to a new primary endpoint.", "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 hierarchy, multiplicity, changes and original registration/protocol/SAP are unread. Do not promote clinical HR to a new primary endpoint." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Does clinical null mean exact no effect or equivalence?", "needed": "Effect direction, interval, prespecified testing and clinical-importance criteria", "role": "Required", "role_reason": "This condition connects Effect direction, interval, prespecified testing and clinical-importance criteria with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Effect direction, interval, prespecified testing and clinical-importance criteria 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 turn this into exact effect 0, equivalence, certain prevention or a new grade F. Clinical-importance criteria and sample-size plans are unlinked. 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 clinical note records HR 0.77, interval 0.53 to 1.11 and P=.16 as null.", "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 turn this into exact effect 0, equivalence, certain prevention or a new grade F. Clinical-importance criteria and sample-size plans are unlinked.", "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 turn this into exact effect 0, equivalence, certain prevention or a new grade F. Clinical-importance criteria and sample-size plans are unlinked." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are laboratory-confirmed OR/FAS/PP and clinical HR the same result?", "needed": "Definitions, units, denominators, times and estimators", "role": "Required", "role_reason": "This condition connects Definitions, units, denominators, times and estimators with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Definitions, units, denominators, times 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 transfer numbers, denominators or analyses between endpoints or count the two results as independent confirmation. 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 laboratory-confirmed 19/384 versus 25/363, adjusted OR 0.69, 95% CI, P=.24 and PP OR/P separately from clinical HR.", "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, denominators or analyses between endpoints or count the two results as independent confirmation.", "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, denominators or analyses between endpoints or count the two results as independent confirmation." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Can the clinical definition extend to other infections, severity or treatment?", "needed": "Relationships among clinical cases, laboratory confirmation and other diseases/severity", "role": "Required", "role_reason": "This condition connects Relationships among clinical cases, laboratory confirmation and other diseases/severity with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Relationships among clinical cases, laboratory confirmation and other diseases/severity 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 replace the clinical definition with laboratory-confirmed infection, all respiratory diseases, severe disease or treatment effects. Diagnostic correspondence and severe outcomes are unlinked. 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 selected question is prevention of clinically defined influenza.", "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": "Do not replace the clinical definition with laboratory-confirmed infection, all respiratory diseases, severe disease or treatment effects. Diagnostic correspondence and severe outcomes are unlinked.", "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 replace the clinical definition with laboratory-confirmed infection, all respiratory diseases, severe disease or treatment effects. Diagnostic correspondence and severe outcomes are unlinked." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Were concurrent exposure, adherence and prevention comparable?", "needed": "Existing prevention/vaccination, school exposure, arm-specific delivery and environment", "role": "Supplementary", "role_reason": "This condition connects Existing prevention/vaccination, school exposure, arm-specific delivery and environment with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Existing prevention/vaccination, school exposure, arm-specific delivery and environment 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: Concurrent prevention, exposure, adherence, environment and arm mapping for the selected clinical outcome are unlinked. Create no new infection-prevention or treatment 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 parent 90-day trial and high-school population 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": "Concurrent prevention, exposure, adherence, environment and arm mapping for the selected clinical outcome are unlinked. Create no new infection-prevention or treatment 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": "Concurrent prevention, exposure, adherence, environment and arm mapping for the selected clinical outcome are unlinked. Create no new infection-prevention or treatment guidance." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Can other routes, observations or gargles be combined?", "needed": "Selected gargling/water controls versus drinking, capsules and other gargles", "role": "Required", "role_reason": "This condition connects Selected gargling/water controls versus drinking, capsules and other gargles with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Selected gargling/water controls versus drinking, capsules and other gargles 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: These materials were not read now and are not combined as independent replication of the selected clinical 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 did not count drinking, capsules or nursing-home observations as replication and describes povidone-iodine/water in verdict 720 as a different intervention.", "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": "These materials were not read now and are not combined as independent replication of the selected clinical 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": "These materials were not read now and are not combined as independent replication of the selected clinical HR." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Do effects persist long term or in other populations?", "needed": "Parent duration context versus selected clinical follow-up and long-term/other populations", "role": "Required", "role_reason": "This condition connects Parent duration context versus selected clinical follow-up and long-term/other populations with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Parent duration context versus selected clinical follow-up and long-term/other populations 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 exact clinical HR window, long-term/other-age effects, severe disease/hospitalization and reinfection effects are unlinked. Create no new dosing or prevention instructions. 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 parent 90-day high-school trial period.", "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": "The exact clinical HR window, long-term/other-age effects, severe disease/hospitalization and reinfection effects are unlinked. Create no new dosing or prevention instructions.", "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 exact clinical HR window, long-term/other-age effects, severe disease/hospitalization and reinfection effects are unlinked. Create no new dosing or prevention instructions." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Can the same Ide report be counted as two trials?", "needed": "Single bibliography, two subclaim results and report/trial relationships", "role": "Required", "role_reason": "This condition connects Single bibliography, two subclaim results and report/trial relationships with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Single bibliography, two subclaim results and report/trial 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: Detailed clinical HR table/report attribution, cohorts and unique/independent totals 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": "Both questions share the single parent Ide 2014 bibliography; clinical values link to a subclaim note. Do not turn the same report/population into two trials.", "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": "Detailed clinical HR table/report attribution, cohorts and unique/independent totals 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": "Detailed clinical HR table/report attribution, cohorts and unique/independent totals are unverified." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What are public funding, product support and COI?", "needed": "Distinguishing public funding from products, employees, COI and research roles", "role": "Required", "role_reason": "This condition connects Distinguishing public funding from products, employees, COI and research roles with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Distinguishing public funding from products, employees, COI and research 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: Support, employee authors, COI and analysis/publication roles are unlinked. Public funding alone does not establish independent confirmation or complete support verification. 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 same parent evidence's Public KAKENHI funding wording.", "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": "Support, employee authors, COI and analysis/publication roles are unlinked. Public funding alone does not establish independent confirmation or complete support verification.", "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": "Support, employee authors, COI and analysis/publication roles are unlinked. Public funding alone does not establish independent confirmation or complete support verification." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Does no adverse-event reporting establish harm verification?", "needed": "Harms collection, arm events/denominators, timing, stopping and missingness", "role": "Supplementary", "role_reason": "This condition connects Harms collection, arm events/denominators, timing, stopping and missingness with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Harms collection, arm events/denominators, timing, stopping 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: Original collection, arm denominators, missingness/stopping and verification of exactly 0 events are absent. Do not turn clinical null or parent Good into new safety certification. 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 parent trial's no-adverse-events-reported statement and Good safety label.", "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": "Original collection, arm denominators, missingness/stopping and verification of exactly 0 events are absent. Do not turn clinical null or parent Good into new safety certification.", "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": "Original collection, arm denominators, missingness/stopping and verification of exactly 0 events are absent. Do not turn clinical null or parent Good into new safety certification." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Were long-term and vulnerable-population harms verified?", "needed": "Population, exposure, concurrent factors and long-term harm scope", "role": "Supplementary", "role_reason": "This condition connects Population, exposure, concurrent factors and long-term harm scope with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Population, exposure, concurrent factors and long-term harm scope 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: Harms by other populations, long-term exposure and alternative causes are unlinked. Nonreporting does not establish no harm. 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 parent's original cautions as historical context without creating 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": "Harms by other populations, long-term exposure and alternative causes are unlinked. Nonreporting does not establish no harm.", "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": "Harms by other populations, long-term exposure and alternative causes are unlinked. Nonreporting does not establish no harm." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "How are original verdicts, both languages, dates and empty histories preserved?", "needed": "Parent/subclaim, notes, absent score and date distinctions", "role": "Required", "role_reason": "This condition connects Parent/subclaim, notes, absent score and date distinctions with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Parent/subclaim, notes, absent score and date distinctions 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 fill absent subclaim score/status/axes from parent values or inherit historical cross-checks as current review/certification. 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, both languages, axes, 2026-09-07, empty correction/deliberation records and subclaim D with the clinical HR note.", "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 fill absent subclaim score/status/axes from parent values or inherit historical cross-checks as current review/certification.", "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 fill absent subclaim score/status/axes from parent values or inherit historical cross-checks as current review/certification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Report/material links and original registration, plan and support access scope", "role": "Required", "role_reason": "This condition connects Report/material links and original registration, plan and support access scope with the definitions, events, denominators, time origin, censoring, analysis, hierarchy and harms of clinically defined influenza HR, distinguishing parent laboratory-confirmed OR/FAS/PP.", "application_exception": "Preserve selected D and the clinical HR null note. Distinguish absent subclaim score/status/axes from parent D with 34 points and laboratory-confirmed context. Do not transfer laboratory events, denominators, OR, PP, the 95% CI label or adjustment to clinical HR. Create no new events, rates, effects, intervals, totals, grades, independence/safety certification or gargling, infection-prevention or treatment instructions.", "criterion": "Material for Report/material links and original registration, plan and support access scope 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, bibliography and the selected note, distinguishing summary reading from unread external materials.", "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": "Both questions share the same parent Ide bibliography and population; clinical HR is linked to a separate subclaim note. Clinical table/report attribution, cohort details and unique/independent totals are unverified. Do not count endpoints, analyses or sheets as new independent trials or participant totals.", "observed_result": "HR 0.77 (0.53 to 1.11), P=.16 was null.", "result_level": "Values from the selected clinically defined subclaim note. Links to original clinical tables, definitions, events, denominators, time origin, interval type/level, adjustment, model, censoring and hierarchy are unverified. Do not substitute the parent bibliography’s laboratory-confirmed results or denominators.", "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": "Both questions share the same parent Ide bibliography and population; clinical HR is linked to a separate subclaim note. Clinical table/report attribution, cohort details and unique/independent totals are unverified. Do not count endpoints, analyses or sheets as new independent trials or participant totals." }, "history": [ { "date": "2026-10-19", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Reader pages and materials were prepared from the existing 23 items. No new clinical search, change in verification status or scoring was performed." } ], "language": "en", "translation_date": "2026-10-19" }