{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "1% Nanocurcumin Oral Gel for Oral Lichen Planus—A Positive 4-Week Add-on Lesion Result in Only 31 Participants",
  "language": "en",
  "translation_date": "2026-10-25",
  "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 topical add-on question is covered?",
      "needed": "The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus",
      "role": "Required",
      "role_reason": "Material on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Curcumin monotherapy and steroid replacement are outside this comparison. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What is the 1% nanomicellar oral gel?",
      "needed": "Composition, nanomicelles, manufacture and active amount of the 1% formulation",
      "role": "Required",
      "role_reason": "Material on Composition, nanomicelles, manufacture and active amount of the 1% formulation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Composition, nanomicelles, manufacture and active amount of the 1% formulation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are swallowed formulations distinguished from topical application?",
      "needed": "Local application to lesions and the scope of swallowing/absorption",
      "role": "Required",
      "role_reason": "Material on Local application to lesions and the scope of swallowing/absorption is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Local application to lesions and the scope of swallowing/absorption must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Does application 3 times daily specify the total active dose?",
      "needed": "Application frequency, amount per application and adherence",
      "role": "Required",
      "role_reason": "Material on Application frequency, amount per application and adherence is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Application frequency, amount per application and adherence must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Daily mg, amount per application and absorbed amount are not calculated from 1% concentration and application 3 times daily. Application amount and adherence remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Does 4 weeks describe both treatment and follow-up?",
      "needed": "Separation of treatment, endpoint measurement and follow-up times",
      "role": "Required",
      "role_reason": "Material on Separation of treatment, endpoint measurement and follow-up times is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of treatment, endpoint measurement and follow-up times must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Relapse after 4 weeks, changes after stopping and durable clearance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Which adults with symptomatic lesions are represented?",
      "needed": "Pain/burning and selection of erosive or ulcerative lesions",
      "role": "Required",
      "role_reason": "Material on Pain/burning and selection of erosive or ulcerative lesions is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Pain/burning and selection of erosive or ulcerative lesions must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What steroid treatment was common to both groups?",
      "needed": "Common 0.1% triamcinolone rinse and the additional-gel comparison",
      "role": "Required",
      "role_reason": "Material on Common 0.1% triamcinolone rinse and the additional-gel comparison is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Common 0.1% triamcinolone rinse and the additional-gel comparison must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Which denominators are represented by 31 people and 14 versus 17?",
      "needed": "Allocation, analysis and completion counts and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "Material on Allocation, analysis and completion counts and endpoint-specific denominators is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Allocation, analysis and completion counts and endpoint-specific denominators must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are 2 and 4 weeks kept within the same trial?",
      "needed": "Timepoint-specific results within the same paper and unique trial families",
      "role": "Required",
      "role_reason": "Material on Timepoint-specific results within the same paper and unique trial families is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Timepoint-specific results within the same paper and unique trial families must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What is the selected result at 4 weeks?",
      "needed": "Baseline-adjusted between-group REU difference and direction at 4 weeks",
      "role": "Required",
      "role_reason": "Material on Baseline-adjusted between-group REU difference and direction at 4 weeks is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Baseline-adjusted between-group REU difference and direction at 4 weeks must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "How does the 2-week result differ from the selected outcome?",
      "needed": "Separation of the supporting 2-week timepoint and selected 4-week result",
      "role": "Required",
      "role_reason": "Material on Separation of the supporting 2-week timepoint and selected 4-week result is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of the supporting 2-week timepoint and selected 4-week result must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The 2-week result is not treated as independent replication of the 4-week result or as a separate trial; prespecified timepoint hierarchy remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are SEs kept distinct from 95% CIs?",
      "needed": "Separation of standard errors and original confidence intervals",
      "role": "Required",
      "role_reason": "Material on Separation of standard errors and original confidence intervals is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of standard errors and original confidence intervals must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original 95% CIs remain unverified; new CIs are not calculated from SEs. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Does P<.001 establish a clinically important difference?",
      "needed": "Statistical signals and criteria important to patients",
      "role": "Required",
      "role_reason": "Material on Statistical signals and criteria important to patients is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Statistical signals and criteria important to patients must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Is the baseline-adjustment analysis specified?",
      "needed": "Baseline-adjustment model, covariates and analysis population",
      "role": "Required",
      "role_reason": "Material on Baseline-adjustment model, covariates and analysis population is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Baseline-adjustment model, covariates and analysis population must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What were the actual randomization procedures?",
      "needed": "Sequence generation, allocation concealment and implementation",
      "role": "Required",
      "role_reason": "Material on Sequence generation, allocation concealment and implementation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Sequence generation, allocation concealment and implementation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are gel masking and REU-assessor blinding distinguished?",
      "needed": "Gel distinguishability and participant/assessor blinding",
      "role": "Required",
      "role_reason": "Material on Gel distinguishability and participant/assessor blinding is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Gel distinguishability and participant/assessor blinding must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How was the REU assessment instrument applied?",
      "needed": "Score range, assessment rules and assessor agreement",
      "role": "Required",
      "role_reason": "Material on Score range, assessment rules and assessor agreement is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Score range, assessment rules and assessor agreement must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Was REU a prespecified primary endpoint?",
      "needed": "Endpoint/timepoint hierarchy in registration, protocol and SAP",
      "role": "Required",
      "role_reason": "Material on Endpoint/timepoint hierarchy in registration, protocol and SAP is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Endpoint/timepoint hierarchy in registration, protocol and SAP must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "How are multiple timepoints and outcomes addressed?",
      "needed": "Planned timepoints, number of outcomes, selective reporting and multiplicity",
      "role": "Required",
      "role_reason": "Material on Planned timepoints, number of outcomes, selective reporting and multiplicity is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Planned timepoints, number of outcomes, selective reporting and multiplicity must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are analyzed/completed counts and observation loss known?",
      "needed": "Timepoint-specific losses, reasons and missing-data handling",
      "role": "Required",
      "role_reason": "Material on Timepoint-specific losses, reasons and missing-data handling is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Timepoint-specific losses, reasons and missing-data handling must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Is pain VAS the same claim as REU?",
      "needed": "Separate presentation of lesion REU and pain VAS",
      "role": "Required",
      "role_reason": "Material on Separate presentation of lesion REU and pain VAS is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separate presentation of lesion REU and pain VAS must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Does lesion-score change establish long-term clearance?",
      "needed": "Separation of a surrogate lesion score, relapse and durable clearance",
      "role": "Required",
      "role_reason": "Material on Separation of a surrogate lesion score, relapse and durable clearance is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of a surrogate lesion score, relapse and durable clearance must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Is there independent replication with the same formulation?",
      "needed": "Same-gel add-on treatment and REU results from other independent teams",
      "role": "Required",
      "role_reason": "Material on Same-gel add-on treatment and REU results from other independent teams is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Same-gel add-on treatment and REU results from other independent teams must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are generic turmeric gel and oral curcumin kept separate?",
      "needed": "Directness for formulation, route and standard treatment",
      "role": "Required",
      "role_reason": "Material on Directness for formulation, route and standard treatment is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Directness for formulation, route and standard treatment must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Other products, monotherapy and direct between-formulation comparative effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Can superiority of a dose or application duration be established?",
      "needed": "Direct concentration/frequency comparisons, subgroups and duration comparisons",
      "role": "Required",
      "role_reason": "Material on Direct concentration/frequency comparisons, subgroups and duration comparisons is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Direct concentration/frequency comparisons, subgroups and duration comparisons must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are the cited registration identifier and unverified registration kept distinct?",
      "needed": "IRCT bibliographic notation and actual registration/change history",
      "role": "Required",
      "role_reason": "Material on IRCT bibliographic notation and actual registration/change history is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on IRCT bibliographic notation and actual registration/change history must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What is the scope of academic funding and declared no-conflict wording?",
      "needed": "Original funding and declared conflict-of-interest statements",
      "role": "Required",
      "role_reason": "Material on Original funding and declared conflict-of-interest statements is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Original funding and declared conflict-of-interest statements must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are product support and employee authorship considered separately?",
      "needed": "Separation of funding, supplied products, company authors and declared conflicts",
      "role": "Required",
      "role_reason": "Material on Separation of funding, supplied products, company authors and declared conflicts is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of funding, supplied products, company authors and declared conflicts must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "How were topical harm events collected?",
      "needed": "Collection and definitions of mucosal irritation, allergy and absorption-related events",
      "role": "Supplementary",
      "role_reason": "Material on Collection and definitions of mucosal irritation, allergy and absorption-related events is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Collection and definitions of mucosal irritation, allergy and absorption-related events must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are harm denominators and comparisons known?",
      "needed": "Exposed participants, affected people and follow-up time by group",
      "role": "Supplementary",
      "role_reason": "Material on Exposed participants, affected people and follow-up time by group is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Exposed participants, affected people and follow-up time by group must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Does the record support stopping standard treatment or long-term safety?",
      "needed": "Common rinse, persistent/rare harms and application boundaries",
      "role": "Supplementary",
      "role_reason": "Material on Common rinse, persistent/rare harms and application boundaries is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Common rinse, persistent/rare harms and application boundaries must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Does an English correction establish external reading?",
      "needed": "Retained Korean/English records and the correction event dated 2026-09-14",
      "role": "Required",
      "role_reason": "Material on Retained Korean/English records and the correction event dated 2026-09-14 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Retained Korean/English records and the correction event dated 2026-09-14 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Were the original grade, axes and date changed?",
      "needed": "Preservation of C54, Caution, original axes and the original date 2026-09-08",
      "role": "Required",
      "role_reason": "Material on Preservation of C54, Caution, original axes and the original date 2026-09-08 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Preservation of C54, Caution, original axes and the original date 2026-09-08 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What material has actually been acquired and read?",
      "needed": "Separation of the stored summary from external abstract, full text, registration and planning material",
      "role": "Required",
      "role_reason": "Material on Separation of the stored summary from external abstract, full text, registration and planning material is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.",
      "application_exception": "Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.",
      "criterion": "Original records on Separation of the stored summary from external abstract, full text, registration and planning material must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.",
      "condition_origin": "These existing conditions are linked to the retained oral-gel add-on and REU question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed."
    }
  ]
}