{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3042-main", "verdict_number": "3042", "title": "Meriva curcumin-phospholipid complex, 2 g/day, as add-on therapy × Improvement of PASI in mild-to-moderate plaque psoriasis", "view_version": "1.0", "view_created_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, "claim_context": { "population": "The retained population is adults with mild-to-moderate plaque psoriasis and PASI below 10. Diagnosis, baseline characteristics, history, prior treatments and exclusion criteria remain incompletely verified; scope is not extended to other severities or psoriasis types.", "intervention": "The record describes a commercial Meriva phospholipid phytosome containing Curcuma longa curcuminoids in a soy-lecithin carrier, with approximately 20% curcuminoids. Batches, measured amounts and bioavailability remain unverified; equivalence to other curcumin formulations is not established.", "dose": "The original value is 2 g/day of the Meriva product. It is not equated to 2 g of conventional curcumin or converted into an active-ingredient amount. Actual dosing, adherence, changes and exposure remain unverified.", "comparator": "The comparison is Meriva added to topical steroids common to both groups versus topical steroids alone. The record states that there was no oral add-on placebo; topical-agent ingredients, potency, use, changes and rescue treatment remain incompletely verified.", "endpoint": "The selected endpoint is PASI change at 12 weeks. Exact between-group adjusted estimates, 95% CIs, prespecified hierarchy, measurement and denominators remain unverified. Secondary PASI75, the mechanistic IL-22 marker and quality of life address separate questions.", "duration": "The record describes 12 weeks of treatment and follow-up. Visit schedules, actual exposure, post-treatment persistence, relapse and long-term follow-up remain unverified; scope is not extended to long-term efficacy or safety.", "excluded_extensions": [ "The original C/50/Caution and B/S/R1/I0/E+/B2/C0 are retained. Historical cross-checking and positive-result narratives are historical records, not current external original-source reading, reassessment or independent clinical certification.", "63 assigned participants, 49 completers and the original narrative of 22% attrition are retained separately as original values. Group analysis denominators, ITT and missing-data handling remain unverified; completer results are not relabeled as analyses of all assigned participants, and attrition is not recalculated.", "The qualitative record describes decreases in both groups, with a larger decrease in the Meriva add-on arm. Exact between-group differences, adjustment models, 95% CIs and P values remain unverified; no new difference or interval is generated.", "Reported randomization/double blinding and a no-add-on control without an oral add-on placebo are both retained. Actual fulfillment of participant, assessor or analyst blinding is not established here.", "PASI change remains distinct from secondary PASI75, the IL-22 mechanism and quality of life. Secondary/mechanistic signals do not substitute for the selected PASI question's prespecified hierarchy, exact add-on effect or patient importance.", "The original record of Indena support and product-related interests is retained. Original funding, product provision, employee authorship, individual COI and research/publication roles remain unread; involvement routes are not newly established or relabeled as absence of support.", "Original precautions that 12 weeks cannot exclude long-term hepatic, biliary or bleeding risks, and that soy-lecithin allergy depends on product composition, are retained. Actual events, collection, exposure/denominators, causality, allergy populations and long-term safety remain unverified.", "The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 and stored-material production date 2026-10-06 remain distinct. Actual content-review dates remain unrecorded; PMID, PMCID and bibliographic links are not relabeled as current original-paper reading." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which PASI add-on effect is presented?", "needed": "12-week PASI with Meriva plus topical steroids versus common topical steroids alone", "role": "Required", "role_reason": "Material on 12-week PASI with Meriva plus topical steroids versus common topical steroids alone is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on 12-week PASI with Meriva plus topical steroids versus common topical steroids alone must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial intervention, comparator and endpoint specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original claim concerns PASI improvement in mild-to-moderate plaque psoriasis. Scope is the add-on effect of a specific phospholipid complex alongside topical steroids.", "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": "Meriva monotherapy and effects of other formulations are outside this selected question.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial intervention, comparator and endpoint specifications" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which psoriasis population is included?", "needed": "Eligibility of adults with mild-to-moderate plaque psoriasis and PASI below 10", "role": "Required", "role_reason": "Material on Eligibility of adults with mild-to-moderate plaque psoriasis and PASI below 10 is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Eligibility of adults with mild-to-moderate plaque psoriasis and PASI below 10 must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Diagnosis, eligibility and baseline-characteristic tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained scope describes adults with mild-to-moderate plaque psoriasis and PASI below 10.", "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": "Diagnostic methods, history, baseline characteristics, prior treatments and exclusion criteria remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnosis, eligibility and baseline-characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What are the Meriva carrier and quantified composition?", "needed": "Commercial phospholipid phytosome, approximately 20% curcuminoids and soy lecithin", "role": "Required", "role_reason": "Material on Commercial phospholipid phytosome, approximately 20% curcuminoids and soy lecithin is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Commercial phospholipid phytosome, approximately 20% curcuminoids and soy lecithin must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product, batch and ingredient-quantification specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained formulation is a commercial phospholipid phytosome with approximately 20% curcuminoids, using a soy-lecithin carrier.", "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 batches, measured composition, manufacturing and bioavailability material remain unverified. Ingredient amounts are not newly converted.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product, batch and ingredient-quantification specifications" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is oral Meriva interchangeable with other curcumin products?", "needed": "Distinguishing oral phospholipid complexes from conventional powder, nano, micellar, piperine-combination and topical products", "role": "Required", "role_reason": "Material on Distinguishing oral phospholipid complexes from conventional powder, nano, micellar, piperine-combination and topical products is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing oral phospholipid complexes from conventional powder, nano, micellar, piperine-combination and topical products must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons for each product and route. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected intervention is oral Meriva. The original record limits interchangeability across other formulations and routes.", "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": "Identical effects across other products and routes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons for each product and route" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What does 2 g/day represent?", "needed": "2 g/day of the Meriva product, with actual dosing and adherence", "role": "Required", "role_reason": "Material on 2 g/day of the Meriva product, with actual dosing and adherence is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on 2 g/day of the Meriva product, with actual dosing and adherence must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product amounts, dosing adherence and change records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained dose is 2 g/day of Meriva. It is not equated to 2 g of conventional curcumin.", "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 dosing, adherence, active-ingredient exposure and dose changes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product amounts, dosing adherence and change records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Does benefit persist beyond 12 weeks?", "needed": "12 weeks of treatment/follow-up and subsequent persistence/relapse", "role": "Required", "role_reason": "Material on 12 weeks of treatment/follow-up and subsequent persistence/relapse is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on 12 weeks of treatment/follow-up and subsequent persistence/relapse must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Visit schedules and post-treatment follow-up. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained duration is 12 weeks of treatment and follow-up, with long-term relapse described as unknown.", "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": "Post-treatment persistence, relapse and long-term follow-up remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedules and post-treatment follow-up" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How was common topical-steroid treatment aligned?", "needed": "Topical-steroid ingredients, potency, sites, use and changes in both groups", "role": "Required", "role_reason": "Material on Topical-steroid ingredients, potency, sites, use and changes in both groups is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Topical-steroid ingredients, potency, sites, use and changes in both groups must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Topical-steroid and rescue-treatment records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The record states that both groups used topical steroids and differed by added Meriva.", "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": "Topical ingredients, potency, dose, application sites, amounts, changes and rescue treatment remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Topical-steroid and rescue-treatment records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Did the control group receive an oral placebo?", "needed": "Distinguishing no-add-on controls from add-on-placebo controls", "role": "Required", "role_reason": "Material on Distinguishing no-add-on controls from add-on-placebo controls is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing no-add-on controls from add-on-placebo controls must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Control-intervention, visit and management specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes a comparison against topical steroids alone without placebo. The retained evidence also describes a no-add-on control.", "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": "Detailed control of expectancy, adherence and concurrent-management differences remains unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control-intervention, visit and management specifications" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What is the identity of the direct report?", "needed": "Retained links among the Antiga report title, PMID, PMCID and DOI", "role": "Required", "role_reason": "Material on Retained links among the Antiga report title, PMID, PMCID and DOI is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Retained links among the Antiga report title, PMID, PMCID and DOI must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original paper and bibliographic records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored bibliography records Antiga 2015, PMID 26090395, PMCID PMC4450233, DOI 10.1155/2015/283634.", "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": "Current external bibliographic/original-file identity and full text remain unread.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper and bibliographic records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Were registration and a prespecified study plan provided?", "needed": "Registration identifiers/timing, protocol and amendments", "role": "Required", "role_reason": "Material on Registration identifiers/timing, protocol and amendments is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Registration identifiers/timing, protocol and amendments must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration, protocol and amendments. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained trial-registration field remains unverified, and the citation contains no registration identifier.", "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, prespecification timing, protocol and amendment history remain unread.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, protocol and amendments" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What is the hierarchy of PASI change and PASI75?", "needed": "Distinguishing 12-week PASI change from secondary PASI75 results", "role": "Required", "role_reason": "Material on Distinguishing 12-week PASI change from secondary PASI75 results is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing 12-week PASI change from secondary PASI75 results must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Endpoint hierarchy in registration, protocol and SAP. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained endpoint is PASI change at 12 weeks, with PASI75 described as secondary.", "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 exact prespecified primary (1st) hierarchy, multiple endpoints and timepoint plans remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint hierarchy in registration, protocol and SAP" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What were the allocation and concealment methods?", "needed": "Randomization procedures, allocation concealment and participant flow", "role": "Required", "role_reason": "Material on Randomization procedures, allocation concealment and participant flow is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Randomization procedures, allocation concealment and participant flow must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods and participant-flow diagrams. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The report is retained as a randomized add-on trial.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Details of allocation sequence, concealment procedures and recruitment flow remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods and participant-flow diagrams" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How are reported double blinding and the no-add-on control interpreted?", "needed": "Blinded parties, maintenance/unblinding and actual control interventions", "role": "Required", "role_reason": "Material on Blinded parties, maintenance/unblinding and actual control interventions is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Blinded parties, maintenance/unblinding and actual control interventions must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original blinding-party, placebo and assessment procedures. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained evidence describes a trial reported as double-blind, with a no-add-on control. Reported wording does not establish actual fulfillment of blinding.", "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": "Participant-, assessor- and analyst-specific blinding methods and maintenance remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original blinding-party, placebo and assessment procedures" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What denominators do 63 assigned and 49 completed represent?", "needed": "Distinguishing allocated, completed and endpoint-specific analysis denominators", "role": "Required", "role_reason": "Material on Distinguishing allocated, completed and endpoint-specific analysis denominators is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing allocated, completed and endpoint-specific analysis denominators must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group flow, analysis populations and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained sample description is 63 assigned participants and 49 completers. Completer results are not relabeled as analyses of all assigned participants.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Group-specific allocation, completion and analysis counts, and ITT denominators, remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, analysis populations and result tables" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What does the original 22% attrition describe?", "needed": "Attrition reasons, distribution by group and the recorded 22%", "role": "Required", "role_reason": "Material on Attrition reasons, distribution by group and the recorded 22% is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Attrition reasons, distribution by group and the recorded 22% must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Attrition/discontinuation reasons and group flow. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes 22% attrition. This historical value is retained without recalculation.", "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": "Attrition timing, reasons, group distribution and associations with outcomes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Attrition/discontinuation reasons and group flow" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the completer analysis and missing-data assumptions?", "needed": "Results in 49 completers, ITT, missing-data handling and analysis models", "role": "Required", "role_reason": "Material on Results in 49 completers, ITT, missing-data handling and analysis models is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Results in 49 completers, ITT, missing-data handling and analysis models must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: SAP, analysis populations and missing-data material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes positive PASI results among 49 completers.", "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": "ITT status, missing-data handling, adjustment models and sensitivity analyses remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, analysis populations and missing-data material" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How was PASI measured?", "needed": "PASI scoring, baseline values, assessors and 12-week measurement", "role": "Required", "role_reason": "Material on PASI scoring, baseline values, assessors and 12-week measurement is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on PASI scoring, baseline values, assessors and 12-week measurement must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Scale, baseline values, assessment procedures and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected endpoint is PASI change at 12 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": "PASI measurement procedures, assessor reliability, baseline values and group distributions remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale, baseline values, assessment procedures and result tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What underlies decreases in both groups and the larger add-on decrease?", "needed": "Group PASI changes and the exact between-group add-on effect", "role": "Required", "role_reason": "Material on Group PASI changes and the exact between-group add-on effect is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Group PASI changes and the exact between-group add-on effect must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original group tables, between-group effects and analysis output. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored result is a narrative of decreases in both groups, with a larger decrease in the Meriva add-on arm.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Exact group changes, between-group estimates and adjustment models are absent from the current summary. A new difference is not generated.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group tables, between-group effects and analysis output" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is an exact adjusted-effect interval available?", "needed": "Between-group adjusted PASI estimate and 95% CI", "role": "Required", "role_reason": "Material on Between-group adjusted PASI estimate and 95% CI is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Between-group adjusted PASI estimate and 95% CI must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Between-group adjusted estimates, 95% CIs and models. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored result leaves the exact adjusted CI unverified.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Adjusted estimates, 95% CIs and model details are absent. Denominators alone do not establish precision.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Between-group adjusted estimates, 95% CIs and models" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What are the tests, multiplicity and analysis timepoints?", "needed": "Exact PASI tests, P values, adjustment and prespecified plans", "role": "Required", "role_reason": "Material on Exact PASI tests, P values, adjustment and prespecified plans is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Exact PASI tests, P values, adjustment and prespecified plans must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: SAP, all tests and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current summary retains a directionally positive narrative.", "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": "Exact P values, multiplicity adjustment, timepoint selection and reporting plans remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, all tests and result tables" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is the PASI difference clinically important?", "needed": "Patient importance, responders and quality of life for scale changes", "role": "Required", "role_reason": "Material on Patient importance, responders and quality of life for scale changes is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Patient importance, responders and quality of life for scale changes must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Important-difference, patient-reported and quality-of-life material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record centers on PASI and separates quality of life.", "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": "Important differences, patient-perceived changes and links to quality-of-life results remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Important-difference, patient-reported and quality-of-life material" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does PASI75 replace the central result?", "needed": "Denominators, response and intervals for secondary PASI75", "role": "Required", "role_reason": "Material on Denominators, response and intervals for secondary PASI75 is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Denominators, response and intervals for secondary PASI75 must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: PASI75 result tables and prespecified hierarchy. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "PASI75 is retained as a secondary result. It does not replace prespecification or the exact effect for PASI change.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Group-specific PASI75 responders, denominators, exact effects and CIs remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PASI75 result tables and prespecified hierarchy" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is IL-22 direction the same outcome as the PASI effect?", "needed": "Distinguishing the IL-22 mechanistic marker from the PASI clinical scale", "role": "Required", "role_reason": "Material on Distinguishing the IL-22 mechanistic marker from the PASI clinical scale is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing the IL-22 mechanistic marker from the PASI clinical scale must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate mechanistic and PASI result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes concordant directions for PASI reduction and IL-22.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Exact IL-22 estimates, prespecified hierarchy and relationship to the clinical scale remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate mechanistic and PASI result tables" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is there independent replication for the same formulation?", "needed": "Report-to-trial links and formulation-specific independent replication", "role": "Required", "role_reason": "Material on Report-to-trial links and formulation-specific independent replication is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Report-to-trial links and formulation-specific independent replication must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Replication reports and trial links under the same conditions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained evidence and citation describe one direct report. Multiple outcomes within one report are not counted as multiple trials.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Independent replication and unique-trial/participant totals for the same product, population and add-on regimen remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Replication reports and trial links under the same conditions" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What information underlies manufacturer Indena support?", "needed": "Manufacturer funding, product support and research roles", "role": "Required", "role_reason": "Material on Manufacturer funding, product support and research roles is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Manufacturer funding, product support and research roles must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding, product-support and manufacturer-role disclosures. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained funding description records Indena support and product-related interests.", "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": "Support types/amounts and roles in design, analysis, original data and publication remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product-support and manufacturer-role disclosures" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are product provision, employee authors and COI separately known?", "needed": "Distinguishing product provision, author employment, COI declarations and funding", "role": "Required", "role_reason": "Material on Distinguishing product provision, author employment, COI declarations and funding is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing product provision, author employment, COI declarations and funding must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original product-provision, author-affiliation and COI disclosures. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Manufacturer-support wording is retained without establishing product provision, employee authorship or declared COI individually.", "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": "Specific documents on individual product support, author affiliations/employment and COI remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-provision, author-affiliation and COI disclosures" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How were short-term adverse events in the same population collected?", "needed": "Event definitions, collection methods and group exposure denominators", "role": "Supplementary", "role_reason": "Material on Event definitions, collection methods and group exposure denominators is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Event definitions, collection methods and group exposure denominators must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event tables, collection methods and exposure denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained safety wording limits exclusion of long-term harms from 12-week material.", "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": "Short-term adverse-event definitions, collection, group events/denominators and discontinuation reasons remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, collection methods and exposure denominators" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are long-term hepatic, biliary and bleeding risks answered?", "needed": "Harms beyond 12 weeks, concomitant medicines and long-term follow-up", "role": "Supplementary", "role_reason": "Material on Harms beyond 12 weeks, concomitant medicines and long-term follow-up is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Harms beyond 12 weeks, concomitant medicines and long-term follow-up must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term harm, concomitant-medicine and follow-up material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record says 12-week material cannot exclude long-term hepatic, biliary or bleeding risks.", "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": "Long-term follow-up, concomitant medicines, event comparisons and harm denominators remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term harm, concomitant-medicine and follow-up material" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What product condition underlies soy-lecithin allergy concerns?", "needed": "Phospholipid-carrier composition and allergy populations/events", "role": "Supplementary", "role_reason": "Material on Phospholipid-carrier composition and allergy populations/events is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Phospholipid-carrier composition and allergy populations/events must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product composition, allergy criteria and event material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record describes a soy-lecithin carrier and allergy checks depending on product composition.", "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": "Trial allergy-exclusion criteria, events and exact product ingredient lists remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product composition, allergy criteria and event material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Can findings extend to generic turmeric treatment or steroid replacement?", "needed": "Distinguishing add-on therapy from monotherapy and treatment replacement", "role": "Required", "role_reason": "Material on Distinguishing add-on therapy from monotherapy and treatment replacement is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Distinguishing add-on therapy from monotherapy and treatment replacement must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct monotherapy and replacement-treatment comparisons. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record limits extension to treatment with dietary turmeric/generic powder or replacement of topical steroids.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Direct comparisons on monotherapy effects, treatment discontinuation/replacement and other products remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct monotherapy and replacement-treatment comparisons" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How are current Korean/English records and the English correction retained?", "needed": "Current English wording, generic evidence wording and correction of 1 field on 2026-09-14", "role": "Required", "role_reason": "Material on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after-correction and language-alignment material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "Current Korean/English material and the correction of 1 English field are retained. Generic English wording does not substitute for verification of exact numbers or denominators.", "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": "Historical before/after English and full-text alignment remain incompletely verified from current inputs alone.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after-correction and language-alignment material" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are C/50, original axes and historical cross-checking?", "needed": "Original grade, score, axes including I0, E+ and C0, and historical records", "role": "Required", "role_reason": "Material on Original grade, score, axes including I0, E+ and C0, and historical records is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Original grade, score, axes including I0, E+ and C0, and historical records must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Review comments and future correction material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "C/50, all axes and historical cross-checking wording are retained as historical values. They are not inherited as completed current content review or fulfilled conditions.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Completed content review is not recorded in the retained material.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review comments and future correction material" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What are the original dates, blank fields and actual reading scope?", "needed": "Original verdict/correction dates, absence of additional selected questions, blank additional-review notes and external unread status", "role": "Required", "role_reason": "Material on Original verdict/correction dates, absence of additional selected questions, blank additional-review notes and external unread status is needed to connect the relevant psoriasis population, Meriva formulation, add-on/common treatment, PASI measurement/timepoint, allocation/completion/analysis denominator or harm scope.", "application_exception": "Effects of a specific formulation added to common topical steroids remain distinct from monotherapy or replacement treatment. Completer results are not relabeled as analyses of all assigned participants; active amounts or new attrition rates are not calculated from product amounts or original records. Scope is not extended to other formulations, secondary endpoints, mechanisms or long-term safety.", "criterion": "Original records on Original verdict/correction dates, absence of additional selected questions, blank additional-review notes and external unread status must link to populations, products, common treatment, between-group add-on effects, denominators, PASI analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, commercial formulation, product amount/duration, common topical treatment, no-add-on control, measurement, allocation/completion/analysis denominators, support and harms in the retained Meriva PASI record.", "condition_origin": "These existing conditions are linked to the retained Meriva PASI add-on question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Needed original material and study plans when provided. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The full retained record was used for preparation. Original verdict date 2026-09-08, correction date 2026-09-14 and blank original values remain preserved.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, topical treatment, placebo/blinding, measurement, add-on effects/intervals, denominators, attrition/missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Needed original material and study plans when provided" } ], "reports": [ { "report_id": "S01", "title": "2015 · Report of a Meriva add-on trial for psoriasis PASI", "url": "https://pubmed.ncbi.nlm.nih.gov/26090395/", "report_type": "Stored description of an add-on trial reported as randomized and double-blind, with a no-add-on control; actual blinding methods and original result tables remain unread", "existence": "The information comes from the stored summary and bibliography of an add-on trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "Stored summary read; external material unread", "study_family": "TF3042-01", "independent_replication": null, "observed_result": "Both groups decreased, with a larger decrease in the Meriva add-on arm; exact adjusted CI unverified", "result_level": "This is retained qualitative add-on-effect wording. Exact group/between-group estimates, intervals, denominators and adjustment remain unverified; it is not relabeled as monotherapy, replacement treatment or a new numerical result.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing trial summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "The stored report/citation summary was read. This does not record possession or abstract/full-text reading of the external original paper. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "External paper · Abstract/full text unread", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "The original PubMed URL and retained bibliography are linked. PMID/PMCID entries do not establish external identity, abstract/full-text acquisition, accessibility or reading. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Trial registration and amendments", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Actual registration identifiers, contents, prespecification timing and amendments remain unverified. Prespecification is not certified. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Study protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original study plans for interventions, comparators, endpoint hierarchy, timepoints and amendments remain unread. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Statistical analysis plan", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original analysis plans for between-group effects, multiplicity, adjustment and ITT/missing-data handling remain unread. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Original funding, product-support, employee-authorship and COI disclosures", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original funding, product provision, author employment, manufacturer roles and individual COI disclosures remain unread. Retained manufacturer-support wording is not relabeled as completed verification of each route. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26090395/" } ] } ], "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": "One Meriva add-on report remains distinct from multiple endpoints, additional reports and independent trials. 63 assigned participants and 49 completers are original denominator records; unique-trial/participant totals, formulation-specific independent replication and endpoint-specific analysis denominators remain unverified." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }