{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2994-s0",
  "verdict_number": "2994",
  "title": "Xylitol five-times-daily prophylaxis × acute otitis media",
  "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": "Early Finnish daycare children; exact ages, formulation-specific eligibility and baseline risk are unverified. The 306 analyzed in the 1996 gum trial are not transferred to 1998 or later reports. R03 concerns high-risk children; ages 1–5 and 250 participants in R04 belong only to the 2024 lower-frequency report.",
    "intervention": "The selected exposure is early regular five-times-daily prophylaxis with xylitol gum/syrup. Uncertain lozenges in 1998, two- or three-times-daily use and use after infection onset are separate contexts. Formulation, frequency and timing changed together, so formulation/frequency-only contributions or superiority are not established.",
    "dose": "Five times daily identifies the original research frequency. Formulation contents, per-use/daily doses, weight/age-specific actual exposure and dose equivalence are unverified. No new doses, conversions, administration schedules or pediatric prevention/treatment instructions are created.",
    "comparator": "The original classification is placebo. Report/formulation-specific placebo composition, sweetness, calories, contact, healthcare use, antibiotics, concomitant care and equivalent management are unverified. Different formulations, frequencies and populations are not converted into direct comparisons under identical conditions.",
    "endpoint": "The selected outcome is prevention of acute otitis media. Preserve 19/157 versus 31/149 in the 1996 gum trial, the original wording of an absolute 8.7-percentage-point reduction, 95% CI 0.4–17.0 and P=.04. Exact child/repeated-event units, denominator flow, models and adjustment are unverified. Positive gum/syrup directions and uncertain lozenges in 1998, null HR 0.88 (0.61–1.30) in 2014, and 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50 and the original 9-event wording in 2024 are separate report contexts.",
    "duration": "The original classification is approximately 2–3 months across trials, with early evidence described as short-term. Exact exposure, event-observation windows and persistence after stopping per report are unverified. Short-term preventive findings are not extended into long-term prevention, treatment of existing otitis media or dental-caries prevention.",
    "excluded_extensions": [
      "Copying 306 participants, 19/157, 31/149 or 8.7 percentage points from 1996 to other formulations in 1998",
      "Combining five-times-daily, two- or three-times-daily and infection-triggered use into a single effect",
      "Transferring ages 1–5, 250 participants or sparse events in 2024 to early populations or proven harm/equivalence",
      "Certifying risk differences, HRs, ORs, children, repeated events and multiple reports as new totals, identical estimands or independent replication",
      "Establishing formulation/frequency-only superiority from evidence differing jointly in formulation, frequency, timing and population",
      "Inheriting parent C54, axes or historical checks as absent subclaim values/completed current review, or generating doses, conversions or pediatric prevention/treatment instructions"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What is the selected original prevention question?",
      "needed": "Original subclaim, exposure, parent and other question",
      "role": "Required",
      "role_reason": "This condition connects Original subclaim, exposure, parent and other question with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 subclaim, exposure, parent and other question must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "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 five-times-daily prophylaxis. The parent's acute-otitis-media prevention claim is distinguished from the other subclaim of two- or three-times-daily or infection-triggered use. Original research exposure is identified without generating administration instructions.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Exact plans, event definitions, denominators and the separate report identity for 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": "Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are subclaim C and parent C54 distinguished?",
      "needed": "Original subclaim grade/note and absent score/status",
      "role": "Required",
      "role_reason": "This condition connects Original subclaim grade/note and absent score/status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 subclaim grade/note and absent score/status 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": [],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original subclaim is C, with a note of positive directions in early gum/syrup trials. It has no separate score or status; parent C54, Caution and historical regimen-specific discussion do not supply a new 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": "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": "N03",
      "question_type": "Evidence condition",
      "question": "Are early children's ages the same as recent ages 1–5?",
      "needed": "Report-specific ages, eligibility and formulation-use conditions",
      "role": "Required",
      "role_reason": "This condition connects Report-specific ages, eligibility and formulation-use conditions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 ages, eligibility and formulation-use conditions 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 early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R04"
      ],
      "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": "Early evidence concerns Finnish daycare children; exact ages and formulation-specific eligibility are unverified. Ages 1–5 in the R04 Persaud 2024 bibliography describe the recent lower-frequency population and do not fill early ages.",
      "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 early/formulation-specific ages, eligibility, exclusions, development and use 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": "Exact early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How do daycare, high-risk and later populations differ?",
      "needed": "Recruitment, country, baseline risk and infection status",
      "role": "Required",
      "role_reason": "This condition connects Recruitment, country, baseline risk and infection status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Recruitment, country, baseline risk and infection status 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 recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 distinguishes early Finnish daycare from later US/Canadian contexts and records R03 Vernacchio 2014 as high-risk children. Baseline risk, recruitment and infection status are not established as identical across populations.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Report-specific recruitment, exclusions, baseline otitis/respiratory infection and environmental risks 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 recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are gum, syrup and lozenges the same exposure?",
      "needed": "Formulation, product, composition, contents and comparator",
      "role": "Required",
      "role_reason": "This condition connects Formulation, product, composition, contents and comparator with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Formulation, product, composition, contents and comparator 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 products, composition, contents, actual exposure, eligibility and comparator specifications are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original interventions were gum, syrup and lozenges. Favorable gum/syrup directions in 1998 are distinguished from uncertain lozenges; composition, contents, products, actual exposure and dose equivalence are unverified.",
      "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 products, composition, contents, actual exposure, eligibility and comparator specifications 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 products, composition, contents, actual exposure, eligibility and comparator specifications are unverified."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are original five-times-daily frequency and actual adherence distinguished?",
      "needed": "Planned frequency, provision, consumption, missed uses and burden",
      "role": "Required",
      "role_reason": "This condition connects Planned frequency, provision, consumption, missed uses and burden with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Planned frequency, provision, consumption, missed uses and burden 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 provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original frequency in 1996 gum and the same early research program in 1998 was five times daily. Planned frequency is not converted into actual provision, consumption or complete adherence; missed uses, refusal and burden remain separately unverified.",
      "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 provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period 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 provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are regular prophylaxis and use after infection onset the same?",
      "needed": "Timing, baseline infection and report identity",
      "role": "Required",
      "role_reason": "This condition connects Timing, baseline infection and report identity with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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, baseline infection and report identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed. This records needed materials; no new research was executed.",
      "current_reports": [],
      "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 distinguishes five-times-daily prevention from use after respiratory-infection onset. The separate report identity, start criteria, formulation, duration and exact effect of infection-triggered use are unlinked; no new report is created.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What does approximately 2–3 months across trials describe?",
      "needed": "Original duration, prevention/follow-up and post-intervention outcomes",
      "role": "Required",
      "role_reason": "This condition connects Original duration, prevention/follow-up and post-intervention outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 duration, prevention/follow-up and post-intervention outcomes 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 exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original classification is approximately 2–3 months across trials, with early evidence described as short-term. Exact report-specific start/end dates, event-observation windows and persistence after stopping are unverified.",
      "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 exposure periods, observation windows, discontinuation and post-intervention 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 exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "How much is known about placebo, contact and concomitant care?",
      "needed": "Formulation-specific placebo, equivalent management and healthcare use",
      "role": "Required",
      "role_reason": "This condition connects Formulation-specific placebo, equivalent management and healthcare use with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Formulation-specific placebo, equivalent management and healthcare use 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: Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original comparator classification is placebo. Report/formulation-specific composition, sweetness, calories, contact, antibiotics, concomitant care, clinical care and equivalent management are unverified.",
      "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": "Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed.",
      "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": "Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "How, and in what units, was acute otitis media identified?",
      "needed": "Diagnosis, assessors, children, repeated events and collection",
      "role": "Required",
      "role_reason": "This condition connects Diagnosis, assessors, children, repeated events and collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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, assessors, children, repeated events and collection 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: Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original endpoints concern acute-otitis-media events/occurrence. Exact diagnoses, adjudicators, children with at least one event versus repeated events, observation windows and collection are unverified. The original English word episodes is not converted into established child-level units.",
      "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": "Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows 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": "Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Which report provides 19/157 versus 31/149?",
      "needed": "1996 gum comparison values, group correspondence and denominators",
      "role": "Required",
      "role_reason": "This condition connects 1996 gum comparison values, group correspondence and denominators with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 1996 gum comparison values, group correspondence 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: Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "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": "19/157 versus 31/149 are original values from 1996 gum. They are not copied into 1998 gum, syrup, lozenges or later reports; exact event units, group correspondence and denominator flow remain separately unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are 306 analyzed the same as allocated/completed denominators?",
      "needed": "Original analysis n, allocation, completion, exclusions and missingness",
      "role": "Required",
      "role_reason": "This condition connects Original analysis n, allocation, completion, exclusions and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 analysis n, allocation, completion, exclusions and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Allocation, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "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 applies only to the 1996 gum trial. It is not the population count for 1998 or later reports; group-specific allocation, completion, follow-up, exclusions and endpoint denominators are unverified.",
      "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, completion, observation, analysis populations and group-specific attrition/exclusion flow 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, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What estimand do 8.7 percentage points, CI and P describe?",
      "needed": "Original absolute difference, direction, interval and model",
      "role": "Required",
      "role_reason": "This condition connects Original absolute difference, direction, interval and model with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 absolute difference, direction, interval 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: Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original difference 8.7 percentage points (95% CI 0.4–17.0), P=.04 and original wording of an absolute 8.7-percentage-point reduction are preserved. Exact model, adjustment, estimand and event units are unverified; no new differences, ratios or NNTs are calculated.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is the level of formulation-specific favorable directions in 1998?",
      "needed": "Separate bibliography, five times daily and formulation-specific outcomes",
      "role": "Required",
      "role_reason": "This condition connects Separate bibliography, five times daily and formulation-specific outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Separate bibliography, five times daily and formulation-specific outcomes 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 n, events, effects, CIs, groups, duration and analyses in 1998 are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R02"
      ],
      "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": "R02 is a separate 1998 citation; the stored account records favorable five-times-daily gum/syrup directions. The combined evidence row's 306 participants and precise events/effects from 1996 are not read as individual 1998 values.",
      "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 n, events, effects, CIs, groups, duration and analyses in 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": "Formulation-specific n, events, effects, CIs, groups, duration and analyses in 1998 are unverified."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are uncertain lozenges combined with favorable gum/syrup?",
      "needed": "1998 lozenges, effects, denominators and actual exposure",
      "role": "Required",
      "role_reason": "This condition connects 1998 lozenges, effects, denominators and actual exposure with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 1998 lozenges, effects, denominators and actual exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R02"
      ],
      "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 uncertain lozenges in 1998, unlike favorable gum/syrup directions. Formulation names alone do not establish equal effects, contents, adherence or eligibility.",
      "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 lozenge effects, CIs, n, product specifications, actual exposure and adherence 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 lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "How are the two reports from the same research program linked?",
      "needed": "1996/1998 bibliography, cohorts, recruitment and independence",
      "role": "Required",
      "role_reason": "This condition connects 1996/1998 bibliography, cohorts, recruitment and independence with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 1996/1998 bibliography, cohorts, recruitment and independence 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: Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "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 and 1998 are separate citations, originally described as the same early research program. Cohort overlap, recruitment, report/registration relationships, exact independence and unique totals are unverified.",
      "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": "Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed.",
      "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": "Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are the later conditions for HR 0.88 the same as original five-times-daily use?",
      "needed": "2014 lower-frequency syrup, high-risk children and original HR",
      "role": "Required",
      "role_reason": "This condition connects 2014 lower-frequency syrup, high-risk children and original HR with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 2014 lower-frequency syrup, high-risk children and original HR 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 frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R03"
      ],
      "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": "R03 Vernacchio 2014 is preserved as a pragmatic lower-frequency syrup trial in high-risk children, HR 0.88 (95% CI 0.61–1.30), null. Exact report-specific frequency, contents, numerical n, observation and model are unverified; a frequency-only effect is not isolated.",
      "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 frequency, contents, n, timing, denominators, model, adjustment and comparison 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": "Individual frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which report provides 6 versus 3 events and OR 2.04?",
      "needed": "2024, 250 participants, target frequency, events, OR and interval",
      "role": "Required",
      "role_reason": "This condition connects 2024, 250 participants, target frequency, events, OR and interval with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 2024, 250 participants, target frequency, events, OR and interval 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 n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R04"
      ],
      "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": "R04 Persaud 2024 records 250 participants, twice-daily-target syrup, 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50. Group-specific allocated/analyzed n, event units and model are unverified; these are not early five-times-daily results.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Group-specific n, event units, model, adjustment, loss to follow-up and actual analysis populations 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 n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What precision boundary does the original 9-event wording describe?",
      "needed": "Sparse 2024 events, wide interval and null interpretation",
      "role": "Required",
      "role_reason": "This condition connects Sparse 2024 events, wide interval and null interpretation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Sparse 2024 events, wide interval and null interpretation 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 denominators, model, loss to follow-up and additional original material for precision assessment are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original 2024 wording of 9 events and the wide interval are retained. A lower-frequency null result is not established as harm, an effect of 0 or complete equivalence; no new event totals, effects or CIs are calculated.",
      "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 denominators, model, loss to follow-up and additional original material for precision assessment are needed.",
      "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 denominators, model, loss to follow-up and additional original material for precision assessment are needed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are a twice-daily target and approximately two actual daily uses the same record?",
      "needed": "2024 target, actual exposure, adherence and discontinuation",
      "role": "Required",
      "role_reason": "This condition connects 2024 target, actual exposure, adherence and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 2024 target, actual exposure, adherence and discontinuation 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 exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R04"
      ],
      "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": "R04 distinguishes a twice-daily target from the original record of approximately two actual uses daily. This is not converted into complete individual adherence or absence of discontinuation.",
      "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 exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period 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 exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Can frequency alone establish administration amounts or doses?",
      "needed": "Formulation contents, per-use/daily doses, weight and age",
      "role": "Required",
      "role_reason": "This condition connects Formulation contents, per-use/daily doses, weight and age with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Formulation contents, per-use/daily doses, weight and age 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: Contents, per-use/daily doses and actual weight/age-specific exposures are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original summary describes five-times-daily or lower-frequency use and formulations but lacks formulation contents, per-use/daily doses and weight-specific ranges. No new amounts, dose conversions, administration schedules or pediatric prevention/treatment instructions are created.",
      "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": "Contents, per-use/daily doses and actual weight/age-specific exposures 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": "Contents, per-use/daily doses and actual weight/age-specific exposures are unverified."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are randomized labels distinguished from actual allocation?",
      "needed": "Design, sequence generation, concealment, formulation and cluster allocation",
      "role": "Required",
      "role_reason": "This condition connects Design, sequence generation, concealment, formulation and cluster allocation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Design, sequence generation, concealment, formulation and cluster allocation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 describes early/later randomized trials, and the 1996 citation includes double-blind randomized wording. Actual generation, concealment, formulation allocation, recruitment order and cluster units are unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are event assessment and parent/assessor awareness known?",
      "needed": "Masking, diagnosis, reporting, healthcare use and recurrent-event collection",
      "role": "Required",
      "role_reason": "This condition connects Masking, diagnosis, reporting, healthcare use and recurrent-event collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Masking, diagnosis, reporting, healthcare use and recurrent-event collection 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 masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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": "Double-blind wording in the 1996 citation is preserved. It is not expanded into verified masking of parents, children, clinicians or adjudicators, or equivalent event collection across every report.",
      "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 masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection 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 masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What were baseline infection, clinical care and concurrent management?",
      "needed": "Baseline risk, prevention, diet, antibiotics and group changes",
      "role": "Required",
      "role_reason": "This condition connects Baseline risk, prevention, diet, antibiotics and group changes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Baseline risk, prevention, diet, antibiotics and group 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: Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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": "Daycare, high-risk and regular-prevention contexts are recorded, but group-specific baseline infection, other prevention, diet, antibiotics, healthcare use, lifestyle changes and analytic handling are unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What estimand is defined by denominators, attrition, repeated events and adjustment?",
      "needed": "ITT/PP, loss to follow-up, clusters, models and missingness",
      "role": "Required",
      "role_reason": "This condition connects ITT/PP, loss to follow-up, clusters, models and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 ITT/PP, loss to follow-up, clusters, models and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 in 1996, 250 participants in 2024, events, HR and OR are preserved. Report-specific ITT/PP, discontinuation, loss to follow-up, cluster/repeated-event handling, adjustment and sensitivity analyses are unverified; individual 1998 n and numerical 2014 n are also unverified.",
      "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": "Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed.",
      "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": "Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are historical registration wording and later registration/plans distinguished?",
      "needed": "Early pre-registration-era wording, unverified 2014 registration and 2024 identifier",
      "role": "Required",
      "role_reason": "This condition connects Early pre-registration-era wording, unverified 2014 registration and 2024 identifier with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Early pre-registration-era wording, unverified 2014 registration and 2024 identifier 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 registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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's registration-does-not-exist-because-it-predates-registration wording is historical.2014 is recorded as not confirmed and 2024 as NCT03055091; registration contents, timing relative to recruitment, hierarchy and changes were not read in this work.",
      "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 registration identity/content, recruitment timing, prospective endpoints/analyses 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": "Report-specific registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Do otitis-prevention outcomes answer caries, treatment or long-term questions?",
      "needed": "Original acute events, separate caries, treatment and post-intervention prevention",
      "role": "Required",
      "role_reason": "This condition connects Original acute events, separate caries, treatment and post-intervention prevention with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 acute events, separate caries, treatment and post-intervention prevention 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: Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed. This records needed materials; no new research was executed.",
      "current_reports": [],
      "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 identifies dental-caries verdict 748 as a different question. This sheet concerns original acute-otitis-media preventive events; direct evidence for treatment of existing otitis, long-term/post-intervention prevention or other clinical effects is unverified.",
      "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": "Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed.",
      "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": "Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Can formulation/frequency-only effects be isolated from later differences?",
      "needed": "Joint changes in formulation, frequency, timing, population and duration",
      "role": "Required",
      "role_reason": "This condition connects Joint changes in formulation, frequency, timing, population and duration with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Joint changes in formulation, frequency, timing, population 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: Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 says formulation and frequency changed together, preventing isolation of formulation-only effects. No new direct superiority or universal prevention effect is established from high-/lower-frequency, infection-timing or population differences.",
      "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": "Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication 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": "Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "How are three evidence rows linked to four citations?",
      "needed": "Combined evidence, separate bibliography, reports, cohorts and outcome mapping",
      "role": "Required",
      "role_reason": "This condition connects Combined evidence, separate bibliography, reports, cohorts and outcome mapping with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Combined evidence, separate bibliography, reports, cohorts and outcome mapping 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, cohort and recruitment relationships, overlap, independence and unique totals are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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": "There are 3 evidence rows and 4 citations. Original n and precise results from 1996 in the early combined row link only to R01; the separate 1998 citation/directions link to R02. R03/R04 are lower-frequency contexts; unique trial, participant and event totals are unrecorded.",
      "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, cohort and recruitment relationships, overlap, independence and unique 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": "Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "How far are public support and product involvement known?",
      "needed": "Report-specific funding, product support, roles and COI",
      "role": "Required",
      "role_reason": "This condition connects Report-specific funding, product support, roles and COI with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 funding, product support, roles and COI 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 funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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;2014 records NIH/non-US government support and 2024 public research support. Individual 1998 support details, institutions, products, design/analysis involvement and COI are unverified.",
      "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 funding, product provision, employees, design/analysis/publication roles, COI and detailed independence 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 funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What material was actually read here?",
      "needed": "Complete stored summary and unread external material",
      "role": "Required",
      "role_reason": "This condition connects Complete stored summary and unread external material with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Complete stored summary and unread external material 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 originals, supplements, registration, plans, support, actual reading records and content review remain outstanding. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 parent stored summary and corresponding summaries for the four citations were read and preserved in full internally. External papers, abstracts, registration, plans and support disclosures are unread/access unattempted; they are not classified as inaccessible or failed access.",
      "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 originals, supplements, registration, plans, support, actual reading records and content review remain outstanding.",
      "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 originals, supplements, registration, plans, support, actual reading records and content review remain outstanding."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are historical verification and current production/review separated?",
      "needed": "Original date, empty corrections/deliberation and historical decision",
      "role": "Required",
      "role_reason": "This condition connects Original date, empty corrections/deliberation and historical decision with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 date, empty corrections/deliberation and historical decision 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: New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded. This records needed materials; no new research was executed.",
      "current_reports": [],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original evidence cut-off 2026-09-07, an empty correction array and an empty deliberation string are preserved. The parent's cross-check-applied wording is historical, not current external verification or completed content review.",
      "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": "New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded.",
      "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": "New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are original languages and event/frequency/formulation scope preserved?",
      "needed": "Original wording, note and language-specific event expressions",
      "role": "Required",
      "role_reason": "This condition connects Original wording, note and language-specific event expressions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 and language-specific event expressions 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-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete. This records needed materials; no new research was executed.",
      "current_reports": [],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "The original English is Five-times-daily prophylaxis, with a note of favorable early gum/syrup trials. Parent Korean/English boundaries concerning frequency, timing, lower-frequency null results and sparse events are preserved; event units and detailed translation are not treated as newly checked against external papers.",
      "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-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete.",
      "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-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are parent axes distinguished from absent subclaim fields?",
      "needed": "Parent axes, null precision and absent subclaim score/status/axes",
      "role": "Required",
      "role_reason": "This condition connects Parent axes, null precision and absent subclaim score/status/axes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Parent axes, null precision and absent subclaim score/status/axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade. This records needed materials; no new research was executed.",
      "current_reports": [],
      "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 values are B/H/R0/I1/E+/B2, null precision, four false flags, derived C and an empty override. The subclaim has no separate score, status or axes; parent C54/Caution do not fill subclaim values or provide new independence certification.",
      "condition_status": "Partly verified",
      "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.",
      "missingness": "Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Are diarrhea, abdominal discomfort, refusal and choking cautions actual event data?",
      "needed": "Formulation/age-specific harm definitions, collection, denominators and discontinuation",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Formulation/age-specific harm definitions, collection, denominators and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Formulation/age-specific harm definitions, collection, denominators and discontinuation 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: Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original safety is Caution, with syrup/lozenge diarrhea, abdominal discomfort/refusal and choking concern with gum in young children. This wording is not converted into actual event counts, rates or verified causation.",
      "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": "Harm definitions, collection, assessment, actual events and formulation/age-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": "Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What are harm exposure, discontinuation, recovery and later observation times?",
      "needed": "Actual exposure, symptoms, refusal, recovery and observation windows",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Actual exposure, symptoms, refusal, recovery and observation windows with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Actual exposure, symptoms, refusal, recovery and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original prevention duration/frequency are recorded, but harm onset, recovery, refusal, discontinuation, later follow-up and the timing relative to actual exposure by formulation/age are unverified.",
      "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": "Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Were harms compared under equivalent observation/comparator conditions?",
      "needed": "Placebo, formulation-specific harm collection, windows and discontinuation comparisons",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Placebo, formulation-specific harm collection, windows and discontinuation comparisons with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Placebo, formulation-specific harm collection, windows and discontinuation comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original placebo/formulation contexts are recorded, but equal harm collection, observation windows and direct harm/discontinuation comparisons between groups are unverified. The preventive-outcome comparator is not inherited as equivalent harm collection.",
      "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": "Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed.",
      "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "Are harm-event counts and actual-exposure denominators available?",
      "needed": "Formulation/age-specific harms, exposure, observation and discontinuation",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Formulation/age-specific harms, exposure, observation and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Formulation/age-specific harms, exposure, observation and discontinuation 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: Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original 306 analyzed, later 250 participants and preventive-event counts are recorded, but actual harm counts, formulation/age-specific exposure/observation denominators and discontinuation are unverified. Preventive-analysis n is not used as the harm denominator.",
      "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": "Harm counts, actual exposure/follow-up denominators, formulation, age 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": "Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "Are infection, concomitant care, formulation, refusal and causation distinguished?",
      "needed": "Concurrent factors, actual events, exposure and discontinuation timing",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Concurrent factors, actual events, exposure and discontinuation timing with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Concurrent factors, actual events, exposure and discontinuation 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: Actual events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 includes formulation-specific possibilities and refusal/discontinuation cautions, but actual events, contributions of concomitant care, infection, formulation/age and causal assessment are unverified.",
      "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 events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed.",
      "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 events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "Are refusal, discontinuation, loss to follow-up and harm reporting known?",
      "needed": "Group-specific refusal, attrition, harm missingness and selective reporting",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Group-specific refusal, attrition, harm missingness and selective reporting with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 refusal, attrition, harm missingness and selective reporting 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 refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread",
      "observation": "Original safety wording concerns possible refusal/discontinuation; the 2024 citation records limited adherence. Report-specific group discontinuation/attrition reasons, missing harms, selective reporting and loss to follow-up are unverified.",
      "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-specific refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed.",
      "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 refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed."
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "How far are harms in other ages/formulations, independent evidence and long-term follow-up known?",
      "needed": "Same exposure, vulnerable populations, independent harms and post-intervention follow-up",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Same exposure, vulnerable populations, independent harms and post-intervention follow-up with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 Same exposure, vulnerable populations, independent harms and post-intervention follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "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 current preserved scope contains preventive findings and harm cautions. Independent harm evidence for the same formulation/frequency, vulnerable ages/diseases and post-intervention follow-up are unverified; no new external search was performed.",
      "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": "Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up 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 harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified."
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "Are originals, conditions, methods, observations and update records distinguished?",
      "needed": "Original texts, condition versions, separate application and change history",
      "role": "Required",
      "role_reason": "This condition connects Original texts, condition versions, separate application and change history with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, 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 texts, condition versions, separate application and change history 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: Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly. This records needed materials; no new research was executed.",
      "current_reports": [],
      "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": "Existing preserved methodology and application conditions are linked; conditions were saved/frozen before observations were recorded at a separate time. This is not upgraded into methodological certification or completed content review; no new research, calculations, grades or administration instructions are created.",
      "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": "Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly.",
      "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": "Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "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": "Same early Uhari research program; report/cohort relationships 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": "Only the 306 analyzed and precise original values from the 1996 gum trial are linked. The combined 1996/1998 evidence row does not supply formulation-specific n, events, effects or CIs for 1998. Exact event units, denominator flow and adjustment are unverified.",
      "source_evidence_date": "2026-09-07",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Preserved copy of the complete parent-verdict stored summary",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-09-07",
          "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 abstract",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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 full text",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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": "Analysis plan and original tables",
          "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": "Intervention and harms",
          "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": "Support and interests",
          "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": "R02",
      "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": "Same early Uhari research program; report/cohort relationships 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": "Original citation and formulation-specific directions only. The 306 participants, precise events and absolute difference from 1996 are not inherited; individual design, formulation eligibility, denominators, effects, CIs and duration in 1998 are unverified.",
      "source_evidence_date": "2026-09-07",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Preserved copy of the complete parent-verdict stored summary",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-09-07",
          "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 abstract",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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 full text",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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": "Analysis plan and original tables",
          "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": "Intervention and harms",
          "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": "Support and interests",
          "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": "R03",
      "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; original context differs from early conditions",
      "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": "Original HR for lower-frequency syrup in high-risk children. Exact report-specific frequency, contents, numerical n, observation window, model and adjustment are unverified. The unidentified infection-triggered-use mention is not arbitrarily assigned to this 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 abstract",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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 full text",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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": "Analysis plan and original tables",
          "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": "Intervention and harms",
          "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": "Support and interests",
          "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": "R04",
      "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; original context differs from early conditions",
      "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": "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, adjustment and loss to follow-up are unverified; the wide interval/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 abstract",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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 full text",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "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": "Analysis plan and original tables",
          "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": "Intervention and harms",
          "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": "Support and interests",
          "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": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Awaiting user review, or actual review remains incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, 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 created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-16"
}