{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Freshly prepared 0.1% nanoparticle curcumin mouthwash × Prevention of oral-mucositis severity during head-and-neck radiotherapy",
  "language": "en",
  "translation_date": "2026-10-24",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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."
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}