{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2994-s1",
  "verdict_number": "2994",
  "title": "Xylitol × lower-frequency or infection-triggered use",
  "view_version": "1.0",
  "view_created_date": "2026-10-16",
  "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": "Core S03 Vernacchio 2014 concerns high-risk children; numerical n, exact ages, eligibility and baseline risk are unverified. Preserve the original 250 participants and bibliographic ages 1–5 in S04 Persaud 2024, without implying group-specific completion/analysis denominators or complete analysis of everyone. The early 306 participants and event denominators from 1996 are not transferred to later reports.",
    "intervention": "The selected claim is two- or three-times-daily or infection-triggered xylitol use. S03 concerns lower-frequency syrup, but exact report-specific target/actual frequency is unverified; S04 records a twice-daily target and approximately two actual uses daily. A specific report for infection-triggered use alone is unlinked and is not arbitrarily assigned to S03/S04.",
    "dose": "Preserve original frequency/formulation and the distinction between target and actual use only. Contents, per-use/daily doses, weight-specific ranges, individual adherence and exact frequency in 2014 are unverified. No new doses, conversions, schedules or pediatric prevention/treatment instructions are created.",
    "comparator": "The parent placebo classification is broad context. Actual comparator products, ingredients, frequency, contact, concomitant care and equivalent infection management in S03/S04 are unverified. Formulation, frequency, timing and population differ together, so individual contributions or superiority are not established.",
    "endpoint": "The selected outcome is prevention of acute otitis media. Preserve null HR 0.88 (95% CI 0.61–1.30) in S03 and 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50 and the original 9-event wording in S04. Event/child units, group-specific denominators, exact observation times, models and adjustment are unverified. HRs, ORs and risk differences are not mixed, and no new rates, effects, CIs or harm/equivalence verdicts are created.",
    "duration": "Approximately 2–3 months across trials is a broad parent classification. Exact use/event-observation windows, initiation criteria relative to infection and post-intervention persistence in each later report are unverified. Findings are not extended into long-term prevention, treatment of existing otitis media, antibiotic replacement or dental-caries prevention.",
    "excluded_extensions": [
      "Transferring early five-times-daily exposure, 306 participants or precise event/effect values from 1996 into lower-frequency/infection-triggered effects or denominators",
      "Inventing the unlinked infection-triggered-only report or automatically assigning it to S03/S04",
      "Mixing the 2014 HR with the 2024 OR, events or denominators to establish new rates, effects, CIs, harm or equivalence",
      "Copying 1996 values to other formulations in 1998 or establishing formulation/frequency/timing-only superiority",
      "Inheriting parent C54, null precision or historical checks as absent subclaim values or completed current review",
      "Generalizing to all ages, formulations, long-term outcomes, caries or treatment, or generating doses, conversions or pediatric prevention/treatment instructions"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What are the selected use conditions and original subclaim grade?",
      "needed": "Original wording, note, grade and parent context",
      "role": "Required",
      "role_reason": "This condition connects Original wording, note, grade and parent context with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Original wording, note, grade and parent 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: Separate subclaim score, status and assessment axes are absent from the source. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 original wording is two- or three-times-daily or infection-triggered use, graded D, with a note that later direct trials did not confirm benefit. The subclaim has no score, status or assessment axes; parent C54 is not substituted.",
      "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": "Separate subclaim score, status and assessment axes are absent from the source.",
      "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": "Separate subclaim score, status and assessment axes are absent from the source."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Did formulation, frequency and timing change together?",
      "needed": "Report-specific formulation, actual exposure and infection timing",
      "role": "Required",
      "role_reason": "This condition connects Report-specific formulation, actual exposure and infection timing with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Report-specific formulation, actual exposure and infection 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: Independent effects of frequency, formulation and timing, and direct comparisons under identical conditions are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 stored account separates five-times-daily prophylaxis from two- or three-times-daily/infection-triggered use and records that formulation and frequency changed together, preventing isolation of formulation-only effects.",
      "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 effects of frequency, formulation and timing, and direct comparisons under identical conditions 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": "Independent effects of frequency, formulation and timing, and direct comparisons under identical conditions are unverified."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What are the population and denominators for high-risk children in 2014?",
      "needed": "S03 eligibility, ages, risk and allocated/analyzed n",
      "role": "Required",
      "role_reason": "This condition connects S03 eligibility, ages, risk and allocated/analyzed n with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S03 eligibility, ages, risk and allocated/analyzed n 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 high-risk definition, exact ages, eligibility and group-specific allocated, completed and analyzed n are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03"
      ],
      "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": "S03 Vernacchio 2014 is described as a trial in high-risk children; numerical n and exact ages are unverified. The early 306 participants from 1996 are not used as this report's denominator.",
      "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 high-risk definition, exact ages, eligibility and group-specific allocated, completed and analyzed n 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": "The high-risk definition, exact ages, eligibility and group-specific allocated, completed and analyzed n are unverified."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What are the 2024 population, ages and analysis denominators?",
      "needed": "S04 original count, ages, eligibility and denominator flow",
      "role": "Required",
      "role_reason": "This condition connects S04 original count, ages, eligibility and denominator flow with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S04 original count, ages, eligibility and denominator flow 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: Group-specific allocated/completed/event-analysis denominators, detailed eligibility and baseline risk are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S04"
      ],
      "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": "S04 Persaud 2024 records the original 250 participants and bibliographic ages 1–5. These are not expanded into group-specific denominators, complete analysis of everyone or ages in early 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": "Group-specific allocated/completed/event-analysis denominators, detailed eligibility and baseline risk 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": "Group-specific allocated/completed/event-analysis denominators, detailed eligibility and baseline risk are unverified."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What was the actual lower-frequency syrup exposure in 2014?",
      "needed": "S03 formulation, target/actual frequency, timing and duration",
      "role": "Required",
      "role_reason": "This condition connects S03 formulation, target/actual frequency, timing and duration with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S03 formulation, target/actual frequency, timing and duration 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 contents, amounts, target/actual frequency, initiation relative to infection and duration are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03"
      ],
      "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": "S03 was a pragmatic lower-frequency syrup randomized trial. The parent's grouped wording of two- or three-times-daily later use is not established as this report's exact target or actual frequency.",
      "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 contents, amounts, target/actual frequency, initiation relative to infection and duration 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 contents, amounts, target/actual frequency, initiation relative to infection and duration are unverified."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are the 2024 target and actual use distinguished?",
      "needed": "S04 planned frequency, actual use and adherence distribution",
      "role": "Required",
      "role_reason": "This condition connects S04 planned frequency, actual use and adherence distribution with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S04 planned frequency, actual use and adherence distribution 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: Individual actual use, contents, duration, refusal, discontinuation and exposure-specific outcomes are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S04"
      ],
      "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": "S04 distinguishes twice-daily-target syrup from the original record of approximately two actual uses daily. This does not establish identical exposure or complete adherence for every child.",
      "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": "Individual actual use, contents, duration, refusal, discontinuation and exposure-specific outcomes 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": "Individual actual use, contents, duration, refusal, discontinuation and exposure-specific outcomes are unverified."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Is a direct report for use only after infection onset linked?",
      "needed": "Infection definition, timing, specific report and denominators",
      "role": "Required",
      "role_reason": "This condition connects Infection definition, timing, specific report and denominators with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Infection definition, timing, specific report and 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: Infection type, onset assessment, delay, specific direct report, effects and denominators are unlinked. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 wording and parent mention later infection-triggered trials, but the current bibliography does not explicitly link a specific report, denominator or quantitative result for use only after infection onset. It is not arbitrarily assigned to S03/S04.",
      "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": "Infection type, onset assessment, delay, specific direct report, effects and denominators 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": "Infection type, onset assessment, delay, specific direct report, effects and denominators are unlinked."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are prevention before infection and treatment of existing otitis the same outcome?",
      "needed": "Timing, prevention, infection course and treatment endpoints",
      "role": "Required",
      "role_reason": "This condition connects Timing, prevention, infection course and treatment endpoints with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Timing, prevention, infection course and treatment endpoints 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: Prospective definitions of prevention relative to infection timing and direct treatment-outcome evidence are unlinked. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 concerns use frequency/timing, while the parent endpoint is prevention of acute otitis media. Use after infection onset is not converted into treatment of existing otitis, symptom relief or antibiotic replacement.",
      "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": "Prospective definitions of prevention relative to infection timing and direct treatment-outcome evidence 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": "Prospective definitions of prevention relative to infection timing and direct treatment-outcome evidence are unlinked."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What were the actual comparators in lower-frequency reports?",
      "needed": "Report-specific comparator products, ingredients, frequency and contact",
      "role": "Required",
      "role_reason": "This condition connects Report-specific comparator products, ingredients, frequency and contact with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Report-specific comparator products, ingredients, frequency and contact 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: Correspondence of comparator formulations, ingredients, exposure, infection care, contact and concomitant care is unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 placebo label is a broad classification. It does not verify comparator ingredients, frequency, equivalent management or infection care in each of S03/S04.",
      "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": "Correspondence of comparator formulations, ingredients, exposure, infection care, contact and concomitant care is 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": "Correspondence of comparator formulations, ingredients, exposure, infection care, contact and concomitant care is unverified."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "How were acute-otitis-media events defined?",
      "needed": "Diagnosis, units, observation windows and ascertainment",
      "role": "Required",
      "role_reason": "This condition connects Diagnosis, units, observation windows and ascertainment with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Diagnosis, units, observation windows and ascertainment 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: Diagnostic criteria, assessors, first/repeated events, observation windows and event-specific denominators are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 S03 endpoint is acute otitis media occurrence; S04 concerns acute otitis media events. Dental-caries verdict 748 is a different question and its effects are not transferred.",
      "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": "Diagnostic criteria, assessors, first/repeated events, observation windows and event-specific denominators 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": "Diagnostic criteria, assessors, first/repeated events, observation windows and event-specific denominators are unverified."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What original values do the 2014 HR and confidence interval represent?",
      "needed": "S03 time-to-event estimate, comparison and model",
      "role": "Required",
      "role_reason": "This condition connects S03 time-to-event estimate, comparison and model with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S03 time-to-event estimate, comparison 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: Exact events, observation time, adjusted model and analysis denominators are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03"
      ],
      "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": "S03 HR 0.88 (95% CI 0.61–1.30) and null-result wording are preserved. They are not converted into OR, absolute differences or an exact effect of 0, or combined with another report's events.",
      "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 events, observation time, adjusted model and analysis denominators 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 events, observation time, adjusted model and analysis denominators are unverified."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the original 2024 events, OR, interval and P value?",
      "needed": "S04 group correspondence, event units, denominators and analysis",
      "role": "Required",
      "role_reason": "This condition connects S04 group correspondence, event units, denominators and analysis with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S04 group correspondence, event units, denominators 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: Exact group correspondence, event/person units, group-specific denominators, model and adjustment are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S04"
      ],
      "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": "S04 records 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50. The original 250 participants and events are preserved without calculating group denominators, new rates or effects.",
      "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 group correspondence, event/person units, group-specific denominators, model and adjustment 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 group correspondence, event/person units, group-specific denominators, model and adjustment are unverified."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What do sparse events and the null result mean?",
      "needed": "Precision, uncertainty, equivalence and noninferiority",
      "role": "Required",
      "role_reason": "This condition connects Precision, uncertainty, equivalence and noninferiority with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Precision, uncertainty, equivalence and noninferiority 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: Prospective equivalence/noninferiority plans, sufficient events and precise estimates are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S04"
      ],
      "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 stored account records only 9 events in 2024 and says the lower-frequency null result does not establish harm or complete equivalence. The wide OR interval is preserved without creating new harm/equivalence verdicts.",
      "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": "Prospective equivalence/noninferiority plans, sufficient events and precise estimates 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": "Prospective equivalence/noninferiority plans, sufficient events and precise estimates are unverified."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How far are randomization, concealment and masking known?",
      "needed": "S03/S04 allocation, product distinguishability, assessment and analysis",
      "role": "Required",
      "role_reason": "This condition connects S03/S04 allocation, product distinguishability, assessment and analysis with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S03/S04 allocation, product distinguishability, assessment 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: Allocation processes, concealment, product distinguishability and diagnostic-assessor/analyst masking are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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": "S03/S04 are described as randomized trials. This summary alone does not verify sequence generation, allocation concealment or participant, diagnostic-assessor or analyst masking.",
      "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 processes, concealment, product distinguishability and diagnostic-assessor/analyst masking 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": "Allocation processes, concealment, product distinguishability and diagnostic-assessor/analyst masking are unverified."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What were completion, missingness and analysis populations?",
      "needed": "Group completion, missing events, follow-up after discontinuation and ITT/PP",
      "role": "Required",
      "role_reason": "This condition connects Group completion, missing events, follow-up after discontinuation and ITT/PP with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Group completion, missing events, follow-up after discontinuation and ITT/PP 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: Group attrition, missing events, follow-up after discontinuation, ITT/PP and missing-data handling/reasons are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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": "S03 lacks numerical n; only the 250 participants in S04 are preserved. Planned frequency, actual use and refusal are not linked to each analysis population.",
      "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": "Group attrition, missing events, follow-up after discontinuation, ITT/PP and missing-data handling/reasons 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": "Group attrition, missing events, follow-up after discontinuation, ITT/PP and missing-data handling/reasons are unverified."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Were concurrent prevention, infection care and exposure equivalent?",
      "needed": "Group-specific care, risk, daycare and diagnostic access",
      "role": "Required",
      "role_reason": "This condition connects Group-specific care, risk, daycare and diagnostic access with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Group-specific care, risk, daycare and diagnostic access 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: Cointerventions, baseline infection risk, daycare exposure and differences in diagnostic access are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 stored account compares trials with different use conditions and populations. Equivalent concurrent prevention, infection care and population exposure are not linked in the stored summary.",
      "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": "Cointerventions, baseline infection risk, daycare exposure and differences in diagnostic access 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": "Cointerventions, baseline infection risk, daycare exposure and differences in diagnostic access are unverified."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are registration identifiers distinguished from actual reading?",
      "needed": "Historical registration wording, report-specific identities and access",
      "role": "Required",
      "role_reason": "This condition connects Historical registration wording, report-specific identities and access with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Historical registration wording, report-specific identities and access 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 originals, change history, exact endpoint plans and details supporting historical absence wording are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 early combined row records registration does not exist because it predates registration; 2014 records not confirmed, and 2024 NCT03055091. These original records are preserved; an identifier alone does not indicate registration reading or fulfillment of prospective plans.",
      "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 originals, change history, exact endpoint plans and details supporting historical absence wording 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": "Registration originals, change history, exact endpoint plans and details supporting historical absence wording are unverified."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are prospective hierarchy, SAP and multiple analyses known?",
      "needed": "Plans, primary endpoints, models, subgroups and changes",
      "role": "Required",
      "role_reason": "This condition connects Plans, primary endpoints, models, subgroups and changes with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Plans, primary endpoints, models, subgroups and changes 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: Prospective first endpoints, event analyses, frequency/formulation subgroups, multiplicity and change history are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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's acute-otitis-media primary-endpoint classification is context. S03/S04 registration, protocols, SAPs and prospective hierarchy were unread in this work; a classification label does not verify prospective status.",
      "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": "Prospective first endpoints, event analyses, frequency/formulation subgroups, multiplicity and change history 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": "Prospective first endpoints, event analyses, frequency/formulation subgroups, multiplicity and change history are unverified."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Where do the favorable high-frequency values from 1996 belong?",
      "needed": "S01 frequency, formulation, denominators and original-effect background",
      "role": "Required",
      "role_reason": "This condition connects S01 frequency, formulation, denominators and original-effect background with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S01 frequency, formulation, denominators and original-effect background 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: A direct comparison varying only frequency in the same population/formulation is unlinked. No new differences, ratios or totals are calculated. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S03",
        "S04"
      ],
      "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": "306 analyzed, 19/157 versus 31/149, a difference of 8.7 percentage points (95% CI 0.4–17.0), P=.04 in the 1996 five-times-daily gum trial are early high-frequency background. They do not supply effects or denominators for selected lower-frequency/infection-triggered use.",
      "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": "A direct comparison varying only frequency in the same population/formulation is unlinked. No new differences, ratios or totals are calculated.",
      "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": "A direct comparison varying only frequency in the same population/formulation is unlinked. No new differences, ratios or totals are calculated."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are 1998 formulation-specific directions distinguished from the combined evidence row?",
      "needed": "S02 bibliography/directions and precise 1996 values",
      "role": "Required",
      "role_reason": "This condition connects S02 bibliography/directions and precise 1996 values with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S02 bibliography/directions and precise 1996 values 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-specific 1998 denominators, exact effects/CIs and links to infection-triggered use are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "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's early row combines 1996/1998; precise values concern 1996 gum. The separate 1998 citation concerns favorable five-times-daily gum/syrup directions and uncertain lozenges, without inheriting 1996 events or denominators.",
      "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-specific 1998 denominators, exact effects/CIs and links to infection-triggered use 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-specific 1998 denominators, exact effects/CIs and links to infection-triggered use are unverified."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are research program, shared reports and independent replication distinguished?",
      "needed": "Reports, trial families, populations, use conditions and unique counts",
      "role": "Required",
      "role_reason": "This condition connects Reports, trial families, populations, use conditions and unique counts with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Reports, trial families, populations, use conditions and unique counts 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: Actual cohort overlap, independence, replication under the same conditions and unique trial/participant totals are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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": "1996/1998 are the same early research program; S03/S04 concern different lower-frequency conditions. Early and later reports are not combined as independent success under identical use conditions; reports, sheets, participants and repeated events are not summed into new unique totals.",
      "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": "Actual cohort overlap, independence, replication under the same conditions and unique trial/participant 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": "Actual cohort overlap, independence, replication under the same conditions and unique trial/participant totals are unverified."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Can this generalize across duration, long-term persistence and populations?",
      "needed": "Report-specific observation, ages, risk groups and effect persistence",
      "role": "Required",
      "role_reason": "This condition connects Report-specific observation, ages, risk groups and effect persistence with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Report-specific observation, ages, risk groups and effect persistence 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 follow-up, long-term events, population heterogeneity, persistence after stopping and generalization are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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 classification is approximately 2–3 months across trials. This does not verify exact duration, long-term persistence or effects in all ages/risk groups for each lower-frequency report.",
      "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 follow-up, long-term events, population heterogeneity, persistence after stopping and generalization 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 follow-up, long-term events, population heterogeneity, persistence after stopping and generalization are unverified."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are funding, support and COI in later reports distinguished?",
      "needed": "S03/S04 funding, products, employees, roles and interests",
      "role": "Required",
      "role_reason": "This condition connects S03/S04 funding, products, employees, roles and interests with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for S03/S04 funding, products, employees, roles and interests 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: Report-specific product/free support, employee authors, COI, funding roles and design/analysis involvement are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S03",
        "S04"
      ],
      "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": "S03 records NIH/non-US government support and S04 public research support. These statements alone do not verify product involvement, employee authors or all interests.",
      "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": "Report-specific product/free support, employee authors, COI, funding roles and design/analysis involvement 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": "Report-specific product/free support, employee authors, COI, funding roles and design/analysis involvement are unverified."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are early support statements inherited by later reports?",
      "needed": "Government/product-involvement scope of the early combined evidence",
      "role": "Required",
      "role_reason": "This condition connects Government/product-involvement scope of the early combined evidence with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Government/product-involvement scope of the early combined evidence 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 involvement, employee authors, COI and funding/research roles in each of 1996/1998 are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "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 early combined row records indexed non-US government support with complete product involvement incompletely verified. This does not fill support or independence gaps in S03/S04.",
      "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 involvement, employee authors, COI and funding/research roles in each of 1996/1998 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": "Product involvement, employee authors, COI and funding/research roles in each of 1996/1998 are unverified."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "How far are pediatric safety, refusal and discontinuation known?",
      "needed": "Report-specific harms, exposure, denominators, discontinuation and vulnerable ages",
      "role": "Supplementary",
      "role_reason": "This condition connects Report-specific harms, exposure, denominators, discontinuation and vulnerable ages with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Report-specific harms, exposure, denominators, discontinuation and vulnerable ages 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: Report-specific event definitions, collection, actual group exposure, denominators, discontinuation, vulnerable ages and long-term/rare harms are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 safety is Caution, recording syrup/lozenge diarrhea, abdominal discomfort/refusal and choking concern with gum in young children. This wording does not establish actual rates or verified lower-frequency harms.",
      "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": "Report-specific event definitions, collection, actual group exposure, denominators, discontinuation, vulnerable ages and long-term/rare harms 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": "Report-specific event definitions, collection, actual group exposure, denominators, discontinuation, vulnerable ages and long-term/rare harms are unverified."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are parent axes, subclaim D, original languages, dates and corrections distinguished?",
      "needed": "Original parent C54, axes, absent subclaim values and historical verdict",
      "role": "Required",
      "role_reason": "This condition connects Original parent C54, axes, absent subclaim values and historical verdict with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Original parent C54, axes, absent subclaim values and historical 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: Subclaim score, status and assessment axes are absent from the source; external details of historical checks and current content review are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 C54, B/H/R0/I1/E+/B2, null precision, four false flags, an empty override and separate subclaim D are preserved. Original Korean/English, 2026-09-07, an empty correction array, an empty deliberation string and historical cross-check wording do not become completed current content review or a subclaim score.",
      "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 assessment axes are absent from the source; external details of historical checks and current content review 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": "Subclaim score, status and assessment axes are absent from the source; external details of historical checks and current content review are unverified."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What was actually read, and what follow-up material is needed?",
      "needed": "Stored summary, original URLs, unread external material and updates",
      "role": "Required",
      "role_reason": "This condition connects Stored summary, original URLs, unread external material and updates with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, support and harms.",
      "application_exception": "Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.",
      "criterion": "Material for Stored summary, original URLs, unread external material and updates 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 acquisition, actual reading, content review and needed original materials remain outstanding. Updates must preserve complete prior texts, condition versions, separate application records and change history. This records needed materials; no new research was executed.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04"
      ],
      "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 complete stored summary and bibliography were used, retaining the four original PubMed URLs. Abstracts, full texts, registration, protocols, SAPs, support and COI are unread/access unattempted; a URL alone does not upgrade reading or verification.",
      "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 acquisition, actual reading, content review and needed original materials remain outstanding. Updates must preserve complete prior texts, condition versions, separate application records and change history.",
      "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 acquisition, actual reading, content review and needed original materials remain outstanding. Updates must preserve complete prior texts, condition versions, separate application records and change history."
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Uhari M, Kontiokari T, Koskela M, Niemelä M. Xylitol chewing gum in prevention of acute otitis media: double blind randomised trial. BMJ. 1996;313:1180-1184. PMID: 8916749. PMCID: PMC2352484. DOI: 10.1136/bmj.313.7066.1180.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/8916749/",
      "report_type": "1996 five-times-daily gum randomized 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": "Early Uhari research program; cohort relationships and independence unverified",
      "independent_replication": "Report from the early Uhari research program. Cohort overlap, independent replication and unique totals relative to 1998 are unverified.",
      "observed_result": "Gum 19/157 versus 31/149; original absolute difference 8.7 percentage points (95% CI 0.4–17.0), P=.04",
      "result_level": "Early high-frequency background for the selected lower-frequency question. Only the 306 analyzed and precise events/effects from 1996 gum are linked; they do not supply effects or denominators for lower-frequency or infection-triggered use.",
      "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/8916749/"
        }
      ]
    },
    {
      "report_id": "S02",
      "title": "Uhari M, Kontiokari T, Niemelä M. A novel use of xylitol sugar in preventing acute otitis media. Pediatrics. 1998;102:879-884. PMID: 9755259. DOI: 10.1542/peds.102.4.879.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/9755259/",
      "report_type": "1998 five-times-daily formulation-specific follow-up report",
      "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": "Early Uhari research program; cohort relationships and independence unverified",
      "independent_replication": "Separate bibliography from 1996 but the same early research program. Cohort/recruitment overlap and exact independence are unverified.",
      "observed_result": "1998 five-times-daily gum/syrup favorable directions; lozenges uncertain, individual effects/denominators/CIs unverified",
      "result_level": "Background from the separate 1998 citation and five-times-daily formulation-specific directions. Precise 1996 values are not inherited, and this is not used as the specific infection-triggered-only report.",
      "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        },
        {
          "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        },
        {
          "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        },
        {
          "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        },
        {
          "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        },
        {
          "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": "Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/9755259/"
        }
      ]
    },
    {
      "report_id": "S03",
      "title": "Vernacchio L, Corwin MJ, Vezina RM, et al. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014;133:289-295. PMID: 24394686. PMCID: PMC3904279. DOI: 10.1542/peds.2013-2373.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/24394686/",
      "report_type": "2014 pragmatic lower-frequency syrup randomized 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": "Later lower-frequency report; conditions differ from early high-frequency use",
      "independent_replication": "Contrary context in later lower-frequency use and high-risk children. This is not direct five-times-daily replication under identical conditions or a frequency-only effect.",
      "observed_result": "HR 0.88 (95% CI 0.61–1.30), null",
      "result_level": "Direct lower-frequency syrup report for the selected question. The original context is high-risk children; numerical n, exact ages, frequency, duration, comparator, model and adjustment are unverified. It is not automatically identified as the infection-triggered-only report.",
      "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        },
        {
          "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        },
        {
          "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        },
        {
          "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        },
        {
          "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        },
        {
          "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": "Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/24394686/"
        }
      ]
    },
    {
      "report_id": "S04",
      "title": "Persaud N, Azarpazhooh A, Keown-Stoneman C, et al. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024. PMID: 37890960. PMCID: PMC10850643. DOI: 10.1136/archdischild-2023-325565.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/37890960/",
      "report_type": "2024 twice-daily-target syrup randomized 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": "Later lower-frequency report; conditions differ from early high-frequency use",
      "independent_replication": "Recent lower-frequency null report. Population, target and actual exposure differ from the original five-times-daily regimen, so it is not used as independent high-frequency confirmation.",
      "observed_result": "6 versus 3 events; OR 2.04 (0.43–12.92), P=.50",
      "result_level": "Direct lower-frequency report for the selected question. Preserve the original 250 participants, bibliographic ages 1–5, twice-daily target/approximately two actual uses daily and original 9-event wording. Group-specific n, event units, model and loss to follow-up are unverified; the null result does not establish harm or equivalence.",
      "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        },
        {
          "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": "Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/37890960/"
        }
      ]
    }
  ],
  "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": "Parent 2994 and the two subclaim sheets share the same preserved report context. S01/S02 belong to the same early research program; S03/S04 concern different lower-frequency conditions. A separate infection-triggered-only identity is unlinked. Four citations, three evidence rows, sheets, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded."
  },
  "history": [
    {
      "date": "2026-10-16",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-16"
}