{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3044-main", "verdict_number": "3044", "title": "1% Nanocurcumin Oral Gel for Oral Lichen Planus—A Positive 4-Week Add-on Lesion Result in Only 31 Participants", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." }, "claim_context": { "population": "The retained population is adults with painful or burning erosive or ulcerative oral lichen planus. Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified.", "intervention": "This is add-on topical application of 1% nanomicellar oral gel containing curcumin derived from Curcuma longa to oral lesions. Composition, active amount, micellar characteristics, excipients, stability and batch information remain unverified.", "dose": "The recorded schedule is application 3 times daily. Amount per application, adherence and actual swallowing/absorption remain unverified; daily active amount is not calculated from concentration and frequency.", "comparator": "Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel. Rinse schedule, adherence and balance of concurrent treatment remain unverified; this is not interpreted as a steroid-replacement trial.", "endpoint": "The selected question concerns the baseline-adjusted between-group difference in REU lesion score at 4 weeks. The same trial result at 2 weeks, pain VAS, relapse and long-term lesion clearance remain separate; prespecified primary-endpoint and timepoint hierarchies remain unverified.", "duration": "Treatment and follow-up are recorded as 4 weeks. Subsequent relapse, changes after stopping, long-term lesion clearance and long-term/rare harms remain unverified.", "excluded_extensions": [ "Generic turmeric gel, swallowed curcumin and other formulations/routes are not treated as interchangeable.", "An add-on effect over common steroid rinse is not extended to monotherapy, steroid replacement or support for stopping standard treatment.", "An REU lesion-score difference is not relabeled as pain relief, cure, relapse prevention, durable clearance or overall safety.", "Standard errors, significance values and a small sample are not relabeled as verification of original confidence intervals or patient-important differences." ] }, "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original question concerns improvement of REU lesion scores in symptomatic oral lichen planus.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Curcumin monotherapy and steroid replacement are outside this comparison.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The intervention is a 1% oral gel containing nanomicellar curcumin derived from Curcuma longa.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The route is topical application to oral lesions.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The recorded schedule is application 3 times daily.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "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.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Treatment and follow-up are recorded as 4 weeks.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Relapse after 4 weeks, changes after stopping and durable clearance remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The population is adults with painful or burning erosive or ulcerative oral lichen planus.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Rinse 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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained sample size is 31 people: active 14 and placebo 17.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The same report gives adjusted REU differences at 2 and 4 weeks.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained adjusted difference at 4 weeks is −5.93 (SE 1.12), P<.001.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The adjusted difference at 2 weeks is −4.77 (SE 0.83), P<.001.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "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.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained results give SE 0.83 at 2 weeks and SE 1.12 at 4 weeks.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original 95% CIs remain unverified; new CIs are not calculated from SEs.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Both timepoints are retained as P<.001.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The result is described as a baseline-adjusted between-group REU difference.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The design is named as a randomized double-blind placebo-gel add-on trial.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained design is described as double blind.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The principal endpoint in the retained record is REU score at 4 weeks.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained verdict selects REU as its main question.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored summary notes the possibility of exaggeration with multiple timepoints/outcomes and a small sample.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained scale is 31 people, active 14/placebo 17.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained summary note separates pain VAS from this REU verdict.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored summary describes REU as a surrogate and separates relapse and long-term lesion clearance.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current stored summary retains 1 direct small-sample topical-trial report.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained original record excludes extension to generic turmeric gel, swallowed curcumin and steroid replacement.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Other products, monotherapy and direct between-formulation comparative effects remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current question concerns 1%, application 3 times daily and 4 weeks.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The bibliography retains IRCT20190523043678N1 while registration status in the original record remains unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The record describes an academic study and reports a declaration of no conflicts.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original funding description states that detailed product roles remain unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained safety description says long-term mucosal irritation, allergy and absorption risks cannot be excluded.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Only the scope of a small sample and 4 weeks of topical use is retained.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained original record does not support stopping standard treatment, and 4-week data cannot exclude long-term risks.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original stored record retains a correction to 1 placeholder field in the English evidence table.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original verdict is C54 with Caution, and its original record date is 2026-09-08.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The full retained summary, including Korean/English content, axes, 1 report and 1 citation, was used for preparation.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread.", "uncertainty": "Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "2020 · Oral lichen planus add-on trial of 1% nanocurcumin gel with common steroid rinse", "url": "https://pubmed.ncbi.nlm.nih.gov/32518558/", "report_type": "Stored summary of a randomized double-blind placebo-gel add-on trial; actual allocation, blinding and analysis details remain unverified", "existence": "The information comes from the stored trial-report summary and bibliography. Existence, public availability, acquisition and actual reading of external papers, registration, study and analysis plans, original result tables, product/support records and harm material remain separately unverified.", "acquired_read": "Stored existing review summary read; external paper, abstract, full text, registration and planning material unread", "study_family": "REU results at 2 and 4 weeks belong to the same 31-person trial record. Timepoints and bibliographic identifiers are not added as separate independent trials.", "independent_replication": "Unverified; 1 stored report remains distinct from unique trials, independent teams and participant totals.", "observed_result": "Adjusted differences: −4.77 (SE 0.83) at 2 weeks and −5.93 (SE 1.12) at 4 weeks, each P<.001", "result_level": "These are baseline-adjusted between-group differences in the stored summary. Actual analysis models, timepoint-specific denominators and original 95% CIs remain unverified. CIs are not newly calculated from SEs, and pain and long-term healing outcomes remain separate.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-10-06T12:09:00.381464+09:00", "qualification": "This is the stored summary actually read. It does not establish full-paper reading or verification of actual allocation/analysis/completion denominators. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." }, { "material_type": "External paper and abstract link", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "The original PubMed citation URL is linked. There is no record of reading the external page, abstract or full text. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." }, { "material_type": "External full paper", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Original bibliography: Bakhshi M et al. Biomed Res Int. 2020;2020:4298193. PMID: 32518558. PMCID: PMC7256737. DOI: 10.1155/2020/4298193. The presence of identifiers remains distinct from full-text acquisition, download and reading. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "IRCT20190523043678N1 appears in the original bibliography, while registration remains unverified in the original record. Actual registration contents, prospective-registration status, change history and URL remain unverified. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." }, { "material_type": "Protocol and analysis plan", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Protocol, SAP, prespecified REU/timepoint hierarchy, multiplicity, models and missing-data plans remain unread. Existence, public availability and acquisition of separate material also remain unverified. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32518558/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The record retains 31 people, active 14/placebo 17, and results at 2 and 4 weeks linked to one trial report. Actual allocation/analysis/completion roles, endpoint denominators, independent replication, and unique-trial and participant totals remain separately unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }