{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Meriva curcumin-phospholipid complex, 2 g/day, as add-on therapy × Improvement of PASI in mild-to-moderate plaque psoriasis",
  "language": "en",
  "translation_date": "2026-10-24",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which 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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}