{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v3043-main",
  "verdict_number": "3043",
  "title": "Freshly prepared 0.1% nanoparticle curcumin mouthwash × Prevention of oral-mucositis severity during head-and-neck radiotherapy",
  "view_version": "1.0",
  "view_created_date": "2026-10-24",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-09-08",
  "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": "Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
  },
  "claim_context": {
    "population": "The retained population is adults receiving head-and-neck radiotherapy. Cancer site/stage, age range, baseline oral condition, pre-existing mucositis and eligibility/exclusion criteria remain unverified; scope is not extended to other cancers or conditions.",
    "intervention": "The intervention is freshly prepared daily 0.1% mouthwash containing nanoparticle curcumin derived from Curcuma longa, used as an oral rinse and spit. Actual particle, additive, content, batch, preparation/storage and contamination-control material remains unverified; swallowed formulations and other oral gels remain distinct.",
    "dose": "The retained concentration is 0.1% mouthwash. Volume and frequency are described only as following the trial protocol; exact amounts, frequency, contact time and adherence remain unverified. Daily or optimal doses are not calculated.",
    "comparator": "The active comparator is 0.15% benzydamine mouthwash. Actual control use, common oral care, radiation dose, concurrent chemotherapy and rescue treatment remain unverified; the comparison is not relabeled as placebo or no treatment.",
    "endpoint": "The selected question concerns severe oral mucositis occurrence/severity by WHO criteria. Exact severity thresholds, visit assessments, group events/denominators, between-group effects/CIs and prespecified hierarchy remain unverified. The separate onset HR of approximately 0.5 and onset delay of about 2 weeks are not severe-mucositis prevention effects.",
    "duration": "The record describes a 6-week comparison during radiotherapy. Rinse initiation, visits, censoring, discontinuation and post-treatment follow-up remain unverified; scope is not extended to long-term efficacy or overall safety.",
    "excluded_extensions": [
      "The original D/30/Caution and B/P/R1/I2/E0/B2/C0 are retained. Historical verdicts and cross-checking are historical records, not current external original-source verification, reassessment or independent clinical certification.",
      "74 is the randomized allocation total. Group allocation, mITT/PP analysis, completion, severity and harm denominators remain unverified; the allocation total is not reused for these denominators, and group sizes are not inferred.",
      "The original narrative of no significant difference in the dichotomized severe outcome is retained. Exact group events, between-group effects, CIs and P values remain unverified; no significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "An onset HR of approximately 0.5 and delay of about 2 weeks concern a separate onset outcome. Exact estimates, CIs, analysis counts, timing tables and calculation basis remain unverified; these are not reassigned to WHO-severity benefit or absolute risk reduction.",
      "The retained descriptions of a triple-blind pilot RCT and mITT/PP do not establish verification of actual randomization, blinding, measurement, inclusion/exclusion, adherence or missing-data handling.",
      "CTRI/2018/04/013362 in the citation and the unverified registration field are both retained. Original registration, protocol, SAP and prespecified endpoint/multiplicity plans remain unread; a listed identifier is not promoted to content verification.",
      "The description of academic research and unverified cash-funding/prepared-product roles are retained. Similar short-term tolerability also does not substitute for verification of events, harm denominators, collection, causality, long-term absorption or contamination control.",
      "The original record date 2026-09-08, correction of 1 English field on 2026-09-14 and stored-material authoring date 2026-10-06 remain distinct. Content-review dates are unrecorded; these dates and bibliographic links do not establish current latest searching or full-text reading."
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which mouthwash and mucositis question is presented?",
      "needed": "Intervention, population, severity, time, active comparator and original claim",
      "role": "Required",
      "role_reason": "Material on Intervention, population, severity, time, active comparator and original claim is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Intervention, population, severity, time, active comparator and original claim must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original-trial question, eligibility and endpoint plans. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original question concerns prevention of oral-mucositis severity during head-and-neck radiotherapy. Onset results from the same trial remain separate supportive information.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Review of the independent claim boundary remains unrecorded.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original-trial question, eligibility and endpoint plans"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What is the 0.1% nanocurcumin mouthwash?",
      "needed": "Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash",
      "role": "Required",
      "role_reason": "Material on Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Formulation composition, nanoparticle characteristics, batch analyses and preparation procedures. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The record describes freshly prepared daily 0.1% mouthwash.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Particle size, content analyses, additives and actual batch quality remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Formulation composition, nanoparticle characteristics, batch analyses and preparation procedures"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are rinse-and-spit use and other oral products distinguished?",
      "needed": "The topical oral rinse-and-spit route",
      "role": "Required",
      "role_reason": "Material on The topical oral rinse-and-spit route is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on The topical oral rinse-and-spit route must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Rinse-use procedures and exposure records. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The route is topical oral rinsing followed by spitting. The original record warns against treating swallowed formulations and topical products as interchangeable.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Actual contact time, swallowed amounts and direct comparisons with gels remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Rinse-use procedures and exposure records"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which radiotherapy population is included?",
      "needed": "Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy",
      "role": "Required",
      "role_reason": "Material on Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Eligibility, baseline-characteristic and radiotherapy-population tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained population is adults receiving head-and-neck radiotherapy.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Age range, cancer site/stage, baseline mucositis, oral condition and exclusion criteria remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Eligibility, baseline-characteristic and radiotherapy-population tables"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What were the radiation dose, chemotherapy and oral-care differences?",
      "needed": "Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care",
      "role": "Required",
      "role_reason": "Material on Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group cancer-treatment, oral-care and rescue-medication tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original material limits the comparison to treatment during radiotherapy.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Group radiation doses, concurrent chemotherapy, oral hygiene, analgesia and rescue treatment remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group cancer-treatment, oral-care and rescue-medication tables"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What was compared with benzydamine?",
      "needed": "Actual use of 0.15% benzydamine mouthwash",
      "role": "Required",
      "role_reason": "Material on Actual use of 0.15% benzydamine mouthwash is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Actual use of 0.15% benzydamine mouthwash must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Control-use procedures and care common to both groups. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained direct comparison is 0.1% nanocurcumin versus 0.15% benzydamine for 6 weeks.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Control volume, frequency, contact time and common care remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Control-use procedures and care common to both groups"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What were the actual volume and frequency for the 0.1% rinse?",
      "needed": "Concentration, volume per 1 rinse, daily frequency and exposure time",
      "role": "Required",
      "role_reason": "Material on Concentration, volume per 1 rinse, daily frequency and exposure time is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Concentration, volume per 1 rinse, daily frequency and exposure time must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Trial rinse procedures and use diaries. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The record describes 0.1% mouthwash, with volume and frequency following the original trial procedures.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Exact mL per use, uses per day, contact time and total dose remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial rinse procedures and use diaries"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "How was quality maintained for freshly prepared daily mouthwash?",
      "needed": "Preparation, storage, expiry, contamination control and quality tracking",
      "role": "Required",
      "role_reason": "Material on Preparation, storage, expiry, contamination control and quality tracking is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Preparation, storage, expiry, contamination control and quality tracking must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Preparation SOPs, stability and microbial/quality records. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The record describes freshly prepared daily nanoparticle mouthwash and limited contamination-control material.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Preparers, sterility/microbiology, storage, stability and test results remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Preparation SOPs, stability and microbial/quality records"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "When during the 6 weeks were treatment and assessments performed?",
      "needed": "Initiation, radiotherapy schedules, visit assessments and completion/discontinuation",
      "role": "Required",
      "role_reason": "Material on Initiation, radiotherapy schedules, visit assessments and completion/discontinuation is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Initiation, radiotherapy schedules, visit assessments and completion/discontinuation must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Trial visit/treatment schedules and follow-up plans. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained duration is 6 weeks during radiotherapy.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Rinse initiation, visit schedules, treatment discontinuation and follow-up beyond 6 weeks remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial visit/treatment schedules and follow-up plans"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are WHO severity and mucositis onset the same outcome?",
      "needed": "Distinguishing WHO severity/occurrence from time to onset",
      "role": "Required",
      "role_reason": "Material on Distinguishing WHO severity/occurrence from time to onset is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Distinguishing WHO severity/occurrence from time to onset must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Endpoint definitions, analysis plans and result tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "WHO oral-mucositis occurrence/severity is the selected question; delayed onset is described as a separate supportive result.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Exact definitions, timepoints and analysis tables for each endpoint remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Endpoint definitions, analysis plans and result tables"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Which WHO grades were dichotomized as severe?",
      "needed": "WHO grades, severity cutoff, assessors and repeated measurement",
      "role": "Required",
      "role_reason": "Material on WHO grades, severity cutoff, assessors and repeated measurement is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on WHO grades, severity cutoff, assessors and repeated measurement must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: WHO grading criteria, assessor guidance and visit tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "Severe oral-mucositis occurrence/severity by WHO criteria and a dichotomized severe-outcome comparison are mentioned.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "WHO cutoffs, assessment manuals, visit grades and assessment agreement remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "WHO grading criteria, assessor guidance and visit tables"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Which endpoint was prespecified as primary (1st)?",
      "needed": "Registration, protocol, SAP and endpoint/analysis hierarchy",
      "role": "Required",
      "role_reason": "Material on Registration, protocol, SAP and endpoint/analysis hierarchy is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Registration, protocol, SAP and endpoint/analysis hierarchy must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original CTRI registration, dated plans and SAP. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained record labels the WHO-severity endpoint as primary.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "The trial prespecified primary (1st) hierarchy and amendments remain unverified because original registration/plans are unread.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original CTRI registration, dated plans and SAP"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What denominator does 74 represent?",
      "needed": "Distinguishing randomized, group-allocation, analysis and completion denominators",
      "role": "Required",
      "role_reason": "Material on Distinguishing randomized, group-allocation, analysis and completion denominators is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Distinguishing randomized, group-allocation, analysis and completion denominators must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: CONSORT flow and group-allocation/analysis tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained evidence describes 74 randomized participants.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Group allocation counts, mITT/PP analysis counts, completion counts and endpoint denominators remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "CONSORT flow and group-allocation/analysis tables"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Who was included in mITT and what did it estimate?",
      "needed": "mITT inclusion conditions, exclusions, group counts and target effects",
      "role": "Required",
      "role_reason": "Material on mITT inclusion conditions, exclusions, group counts and target effects is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on mITT inclusion conditions, exclusions, group counts and target effects must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: mITT definitions, flow and endpoint-specific result tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The design mentions mITT and PP; the retained explanation describes an mITT onset HR signal.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "mITT definitions, exclusion reasons, group denominators and links to severity analyses remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "mITT definitions, flow and endpoint-specific result tables"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "How did PP results and denominators differ from mITT?",
      "needed": "PP adherence criteria, denominators and severity/onset results",
      "role": "Required",
      "role_reason": "Material on PP adherence criteria, denominators and severity/onset results is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on PP adherence criteria, denominators and severity/onset results must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: PP definitions, analysis and attrition tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "Only the description that the trial included PP remains in the record.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "PP group counts, adherence conditions, effect estimates and differences from mITT remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "PP definitions, analysis and attrition tables"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What was the between-group result for severe-mucositis prevention?",
      "needed": "Severe events/denominators, between-group effects, CIs and timepoints",
      "role": "Required",
      "role_reason": "Material on Severe events/denominators, between-group effects, CIs and timepoints is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Severe events/denominators, between-group effects, CIs and timepoints must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: WHO-severity result tables and analysis output. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original narrative describes no significant difference in the dichotomized severe outcome and no evidence of better severity prevention than benzydamine.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Group event counts, exact effects/RRs/differences, CIs, P values and analysis timepoints remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "WHO-severity result tables and analysis output"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What do the onset HR of approximately 0.5 and delay of about 2 weeks mean?",
      "needed": "Definitions, units, denominators and CIs for time-to-onset results",
      "role": "Required",
      "role_reason": "Material on Definitions, units, denominators and CIs for time-to-onset results is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Definitions, units, denominators and CIs for time-to-onset results must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Onset curves, hazard analyses and timing tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained result describes delayed onset with an HR of approximately 0.5; the original summary describes onset about 2 weeks later. The mITT onset signal remains distinct from WHO severity.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Exact HRs, CIs, analysis counts, event counts, median onset times and the calculation basis for the 2-week delay remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Onset curves, hazard analyses and timing tables"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "How were onset assessment intervals, censoring and follow-up handled?",
      "needed": "Assessment intervals, censoring, event times and radiotherapy exposure",
      "role": "Required",
      "role_reason": "Material on Assessment intervals, censoring, event times and radiotherapy exposure is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Assessment intervals, censoring, event times and radiotherapy exposure must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Onset statistical methods and individual timing/follow-up material. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original material describes a 6-week duration and an onset HR signal.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Visit intervals, censoring rules, event counts, follow-up losses and proportional-hazards assumptions remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Onset statistical methods and individual timing/follow-up material"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Does no significant difference establish equivalence?",
      "needed": "Superiority/noninferiority/equivalence designs, margins and CIs",
      "role": "Required",
      "role_reason": "Material on Superiority/noninferiority/equivalence designs, margins and CIs is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Superiority/noninferiority/equivalence designs, margins and CIs must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Trial hypotheses, margins and effect intervals. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original record says superiority and equivalence were not established and complete ineffectiveness cannot be concluded.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Equivalence/noninferiority margins, testing designs and relevant CIs remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial hypotheses, margins and effect intervals"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "How were random sequences and allocation concealment implemented?",
      "needed": "Sequence generation, allocation concealment and baseline balance",
      "role": "Required",
      "role_reason": "Material on Sequence generation, allocation concealment and baseline balance is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Sequence generation, allocation concealment and baseline balance must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Randomization procedures and baseline tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained descriptions identify a pilot RCT and 74 randomized participants.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Sequence generation, allocation ratio, concealment and baseline balance remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Randomization procedures and baseline tables"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What did triple blinding and blinded WHO assessment cover?",
      "needed": "Participant, provider and assessor blinding, and distinguishability of the rinses",
      "role": "Required",
      "role_reason": "Material on Participant, provider and assessor blinding, and distinguishability of the rinses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Participant, provider and assessor blinding, and distinguishability of the rinses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Blinding procedures, product appearance and assessor guidance. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The study title and design describe a triple-blind pilot RCT.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Blinded roles, color/taste, maintenance of blinding, WHO assessors and measurement reliability remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Blinding procedures, product appearance and assessor guidance"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What were rinse adherence and treatment deviations?",
      "needed": "Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment",
      "role": "Required",
      "role_reason": "Material on Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Use diaries, discontinuation reasons and analysis plans. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained record describes a 6-week rinse comparison and mITT/PP analyses.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Adherence, discontinuation/crossover, rescue treatment and handling of deviations remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Use diaries, discontinuation reasons and analysis plans"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Which participants had missing outcome data?",
      "needed": "Group missingness/attrition, reasons, handling and sensitivity analyses",
      "role": "Required",
      "role_reason": "Material on Group missingness/attrition, reasons, handling and sensitivity analyses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Group missingness/attrition, reasons, handling and sensitivity analyses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group flow, missing-data handling and sensitivity tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original record describes 74 randomized participants and an mITT/PP design.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Endpoint missingness, group attrition, reasons and imputation/sensitivity analyses remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group flow, missing-data handling and sensitivity tables"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "How did registration plans correspond to reported results?",
      "needed": "CTRI, protocol, SAP and all planned endpoints/analyses",
      "role": "Required",
      "role_reason": "Material on CTRI, protocol, SAP and all planned endpoints/analyses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on CTRI, protocol, SAP and all planned endpoints/analyses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration history, protocol, SAP and complete endpoint tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The citation lists CTRI/2018/04/013362, while the original trial-registration field says unverified.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Correspondence remains unverified because original registration, plan versions and result tables are unread.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration history, protocol, SAP and complete endpoint tables"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What were the interval and clinical importance of the severity difference?",
      "needed": "Exact between-group effects, CIs, importance thresholds and required information",
      "role": "Required",
      "role_reason": "Material on Exact between-group effects, CIs, importance thresholds and required information is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Exact between-group effects, CIs, importance thresholds and required information must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Between-group effects/CIs and sample-size/importance plans. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The retained description concerns a small pilot with 74 participants and no significant severity difference.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Effect CIs, prespecified important differences, design sample-size rationale and exact P values remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Between-group effects/CIs and sample-size/importance plans"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "How were multiple WHO, onset, mITT and PP comparisons planned?",
      "needed": "Planned analysis counts, hierarchy/adjustment and exploratory labels",
      "role": "Required",
      "role_reason": "Material on Planned analysis counts, hierarchy/adjustment and exploratory labels is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Planned analysis counts, hierarchy/adjustment and exploratory labels must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: SAP, planned-comparison tables and analysis-specific results. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "WHO severity, onset and mITT/PP are mentioned together.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Prespecified comparison lists, multiplicity handling and exploratory/confirmatory distinctions remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "SAP, planned-comparison tables and analysis-specific results"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "How are the paper summary and citation related?",
      "needed": "Family links among trial report, citation and registration",
      "role": "Required",
      "role_reason": "Material on Family links among trial report, citation and registration is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Family links among trial report, citation and registration must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original paper, registration and reports from the same trial. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "1 stored evidence entry and 1 citation point to the Shah et al. 2020 pilot RCT.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "External identity, registration/paper family links and unique-trial/participant totals remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original paper, registration and reports from the same trial"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What is within scope and what remains unknown?",
      "needed": "The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity",
      "role": "Required",
      "role_reason": "Material on The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Additional studies of the exact same combination. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original record limits application to the specified formulation, route, dose, duration, population, endpoint and comparator combination.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Direct effects of other mouthwashes, gels, swallowed curcumin, other conditions and periods beyond 6 weeks remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Additional studies of the exact same combination"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are PMID, DOI, CTRI and actual reading distinguished?",
      "needed": "Original citation and actual paper/registration reading status",
      "role": "Required",
      "role_reason": "Material on Original citation and actual paper/registration reading status is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Original citation and actual paper/registration reading status must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original paper, registration and plans corresponding to the citation. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original citation lists Shah S et al., Indian J Dent Res. 2020;31:718-727, PMID 33433509, DOI 10.4103/ijdr.IJDR_822_18, CTRI/2018/04/013362. The material actually read is the stored summary.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "External abstract/full text, CTRI and protocol remain unread; external access was not attempted.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original paper, registration and plans corresponding to the citation"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What do 2026-09-08 and the correction date mean?",
      "needed": "Distinguishing the original record date, correction date and current authoring time",
      "role": "Required",
      "role_reason": "Material on Distinguishing the original record date, correction date and current authoring time is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Distinguishing the original record date, correction date and current authoring time must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Publication, receipt and reading records for actually provided new evidence. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original record date is 2026-09-08; the English correction date is 2026-09-14.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "No explicit evidence-search cutoff or current external-reading date is recorded.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Publication, receipt and reading records for actually provided new evidence"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "How should the English table and historical correction of 1 field be read?",
      "needed": "Roles of Korean/English evidence wording and the historical correction",
      "role": "Required",
      "role_reason": "Material on Roles of Korean/English evidence wording and the historical correction is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Roles of Korean/English evidence wording and the historical correction must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Complete before/after originals and specific English result tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original English summary describes 74 participants, an onset delay of about 2 weeks and no significant severity difference. Generic descriptions remain in the English evidence table; the historical correction states that 1 field changed.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Original before/after wording identifying the changed field and detailed English-content review remain unrecorded.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Complete before/after originals and specific English result tables"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "How does the original D/30 verdict differ from current material review?",
      "needed": "Roles of the original grade, score, caution label and historical verdict",
      "role": "Required",
      "role_reason": "Material on Roles of the original grade, score, caution label and historical verdict is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Roles of the original grade, score, caution label and historical verdict must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original verdict and subsequently provided correction events. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original D/30/Caution verdict is retained as historical information. Historical verification wording does not establish current external original-source reading or completed content review.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Completed current content review or external clinical validation is not recorded.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original verdict and subsequently provided correction events"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What were cash funding, prepared-product support and author interests?",
      "needed": "Cash/product support, affiliations, conflicts of interest and reporting roles",
      "role": "Required",
      "role_reason": "Material on Cash/product support, affiliations, conflicts of interest and reporting roles is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Cash/product support, affiliations, conflicts of interest and reporting roles must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Funding/COI declarations, author affiliations and product-support descriptions. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The record describes academic research, with details of cash funding and prepared-product roles unverified.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Amounts, prepared-product support, employee authorship and original conflict-of-interest declarations remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Funding/COI declarations, author affiliations and product-support descriptions"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Which events and denominators underlie short-term tolerability?",
      "needed": "Event definitions, collection, group events/denominators, discontinuation and missingness",
      "role": "Required",
      "role_reason": "Material on Event definitions, collection, group events/denominators, discontinuation and missingness is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Event definitions, collection, group events/denominators, discontinuation and missingness must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group adverse-event/discontinuation and harm-collection tables. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original safety wording describes similar short-term tolerability in a small trial.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Event types, group event/person counts, harm denominators, collection methods and attrition remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group adverse-event/discontinuation and harm-collection tables"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "How are harm timing, radiotherapy and concurrent exposures distinguished?",
      "needed": "Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes",
      "role": "Required",
      "role_reason": "Material on Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Individual-event timelines, concomitant medicines and original harm material. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The original material describes topical rinsing during radiotherapy and 6-week short-term tolerability.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Individual-event timing, improvement after withdrawal/re-exposure, concomitant medicines and underlying-condition alternatives remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual-event timelines, concomitant medicines and original harm material"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What is known about safety beyond the short trial?",
      "needed": "Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups",
      "role": "Required",
      "role_reason": "Material on Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Absorption/long-term follow-up, quality/contamination and vulnerable-population material. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The record describes limited long-term safety, absorption and contamination-control material for freshly prepared nanoparticle mouthwash.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Long-term exposure, absorbed amounts, rare events, vulnerable populations and preparation-quality harm material remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Absorption/long-term follow-up, quality/contamination and vulnerable-population material"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Were the same formulation, severity outcome or harms repeated elsewhere?",
      "needed": "Other teams/unique trials, formulation/endpoint matching, report families and harm events",
      "role": "Required",
      "role_reason": "Material on Other teams/unique trials, formulation/endpoint matching, report families and harm events is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Other teams/unique trials, formulation/endpoint matching, report families and harm events must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Additional original reports with the same formulation, population, comparison and endpoint. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The stored record contains 1 trial summary and 1 citation. Other oral gels or general curcumin benefits are not treated as replication of this question.",
      "condition_status": "Unverified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Independent replication of severity findings for the same rinse, independent harm cases and unique-trial counts remain unverified.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Additional original reports with the same formulation, population, comparison and endpoint"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How are the summary actually read and unread original materials distinguished?",
      "needed": "Stored summary, external paper/registration/plans/quality/harms slots and update events",
      "role": "Required",
      "role_reason": "Material on Stored summary, external paper/registration/plans/quality/harms slots and update events is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.",
      "application_exception": "Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.",
      "criterion": "Original records on Stored summary, external paper/registration/plans/quality/harms slots and update events must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.",
      "condition_origin": "These existing conditions are linked to the retained mouthwash and WHO-severity question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original or correction material provided or separately authorized by the user. This records needed materials; no new research was executed.",
      "current_reports": [
        "R01"
      ],
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.",
      "observation": "The stored summary is the material read. The original PubMed citation URL is linked; external materials remain unread and external access was not attempted.",
      "condition_status": "Partly verified",
      "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.",
      "missingness": "Full text, registration, plans and additional materials have not been acquired/read; existing content review remains incomplete.",
      "uncertainty": "Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original or correction material provided or separately authorized by the user"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "2020 · Report of a nanocurcumin mouthwash trial for radiation oral mucositis",
      "url": "https://pubmed.ncbi.nlm.nih.gov/33433509/",
      "report_type": "Stored summary of a triple-blind, active-controlled pilot RCT; details of mITT/PP, actual procedures and original result tables remain unverified",
      "existence": "The information comes from the stored trial-report summary and bibliography. Existence/public availability, acquisition and actual reading of external papers, registration, study and analysis plans, result tables, formulation/preparation, harms and support disclosures remain separately unverified.",
      "acquired_read": "Stored existing review summary read for preparation; external abstract/full text and registration unread, with external access not attempted",
      "study_family": "SF01-Shah-2020-mouthwash-native",
      "independent_replication": "Unverified; 1 report in the original record is not certification of independent replication",
      "observed_result": "Onset delayed with an HR of approximately 0.5; no significant difference in the dichotomized severe outcome",
      "result_level": "These are original narratives about selected WHO severity and a separate onset outcome. Exact severity effects, CIs and denominators remain unverified; the onset signal is not relabeled as prevention of severe mucositis.",
      "source_evidence_date": "2026-09-08",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Existing stored summary acquired",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Stored summary read",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "This is the stored summary actually read; it does not establish full-paper reading. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "External paper identity link",
          "public_status": "Original bibliography link only; external content unread",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "The original PubMed citation URL is linked. External page contents, abstract and full text remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "External full paper",
          "public_status": "Original bibliography link only; external content unread",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "This is the original paper bibliographic link; it does not establish full-text acquisition, download or reading. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Registration material",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "CTRI/2018/04/013362 appears in the original citation, but the registration URL, contents and plan history remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Protocol and analysis plan",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "Protocol, SAP and prespecified endpoint/analysis plans remain unread; existence and public availability of separate materials also remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Group flow, analysis and result tables",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "74 is the allocation denominator; group flow, mITT/PP, WHO/onset result tables and actual analysis denominators remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Mouthwash formulation, preparation and use material",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "The descriptions of 0.1% concentration and fresh preparation are retained. Composition, actual volume/frequency, quality and public availability/acquisition of additional documents remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Harm, absorption, long-term and quality material",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "Short-term tolerability wording is not relabeled as absence of events or overall safety. Harm counts, absorption, long-term follow-up and contamination-control material remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        },
        {
          "material_type": "Funding, product-support and conflict-of-interest material",
          "public_status": "Needed material; existence and public availability unverified",
          "access_status": "Unread; no access attempt",
          "acquired": false,
          "actually_read": "Unread",
          "as_of": "2026-09-08 (original record date; not a current external-reading date)",
          "qualification": "The academic-setting description and unverified cash/prepared-product roles are retained; original support and conflict-of-interest disclosures remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/33433509/"
        }
      ]
    }
  ],
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "This record links a trial-report summary and original citation; material slots are not counted as independent trials. The 74 randomized participants remain distinct from unique-participant totals and endpoint analysis denominators; unique-trial counts, unique-participant totals and independent replication remain unverified."
  },
  "history": [
    {
      "date": "2026-10-24",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public view and materials were prepared from the existing 38 items. No new clinical search, verification-state change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-24"
}