{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Dry-eye combination capsule · Evidence Check for reduced artificial-tear use",
  "language": "en",
  "translation_date": "2026-10-12",
  "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What are the original wording and subclaim verdict for artificial-tear use?",
      "needed": "Distinguish selected-row grade/note from the parent verdict",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Distinguish selected-row grade/note from the parent verdict; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Present artificial-tear use separately from tear-volume/symptom verdicts"
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Which trial directly reported the selected use outcome?",
      "needed": "Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Separate different trials of the same formulation and their direct outcomes"
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are the follow-up population and applicability verified?",
      "needed": "Follow-up dry-eye eligibility, baseline, severity and centers",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Follow-up dry-eye eligibility, baseline, severity and centers; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show recruitment-population differences between 2021 and the follow-up"
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What are the study identity and ingredient combination?",
      "needed": "Fixed combination and product/exposure specifications for each trial",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Fixed combination and product/exposure specifications for each trial; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish the fixed finished product from individual-ingredient efficacy and other formulations"
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are placebo composition and trial-specific comparators distinguished?",
      "needed": "Active/placebo composition, appearance, exposure and blinding",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Active/placebo composition, appearance, exposure and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show actual comparator conditions separately for each trial"
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What are the units and definition of artificial-tear use?",
      "needed": "Original definitions of frequency, volume, days, people or user proportion",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Original definitions of frequency, volume, days, people or user proportion; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Present use units, aggregation and person denominators"
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are baseline, group-specific final values and changes available?",
      "needed": "Group-specific original baseline, day-56 and change values for use",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Group-specific original baseline, day-56 and change values for use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Separate use quantities from values/changes in other outcomes"
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are between-group use effects and confidence intervals provided?",
      "needed": "Use differences, ratios, effect scales, CIs and tests",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Use differences, ratios, effect scales, CIs and tests; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Present the original test alongside missing effects/intervals"
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What prespecified outcome hierarchy applies to use?",
      "needed": "Primary, secondary or exploratory use outcome, plans and multiplicity",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Primary, secondary or exploratory use outcome, plans and multiplicity; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish primary/secondary/exploratory outcomes and the use-analysis hierarchy"
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are the measurement period and repeated units for use verified?",
      "needed": "Baseline/day-56 use observation windows, records and repeated-measure handling",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Baseline/day-56 use observation windows, records and repeated-measure handling; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish report assessment timing from actual use-observation windows"
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What policies governed permitted, rescue or changed artificial tears?",
      "needed": "Permitted adjunctive care, products, rescue, changes and recording rules in both groups",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Permitted adjunctive care, products, rescue, changes and recording rules in both groups; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish adjunctive-care policy/actual use from the scope of product effects"
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are follow-up allocation, analysis and withdrawal denominators distinguished?",
      "needed": "Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show randomized, analyzed and use-observation denominators separately"
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Was representative-trial complete-case analysis transferred to the follow-up?",
      "needed": "Original/follow-up analysis populations, denominators and missingness",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Original/follow-up analysis populations, denominators and missingness; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish each recruitment population and original analysis method"
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "What is the scope of randomization, concealment and blinded use measurement?",
      "needed": "Follow-up allocation, measurement, artificial-tear records and blinding",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Follow-up allocation, measurement, artificial-tear records and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish design labels from actual implementation/use-measurement limitations"
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Do positive OSDI/Schirmer results mean reduced artificial-tear use?",
      "needed": "Outcome-specific direct results for symptoms, tear volume and adjunctive-care use",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Outcome-specific direct results for symptoms, tear volume and adjunctive-care use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show distinct outcomes alongside the selected null result"
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Were representative OSDI baseline/final values converted into use quantities?",
      "needed": "Distinguish scales/units and within-group/between-group estimands",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Distinguish scales/units and within-group/between-group estimands; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Separate symptom scales from adjunctive-care use quantities"
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are clinically important test/symptom differences and use-reduction thresholds the same?",
      "needed": "Use-outcome importance/interpretation criteria and direct intervals",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Use-outcome importance/interpretation criteria and direct intervals; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish test/symptom thresholds from direct use-outcome criteria"
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are registration identifiers and external plans distinguished?",
      "needed": "Representative CTRI/follow-up NCT and trial-specific plans/history",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Representative CTRI/follow-up NCT and trial-specific plans/history; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish trial identifiers from actual reading/prespecified plans"
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Does the same-formulation follow-up mean the same participants or independent-company replication?",
      "needed": "Trial populations, centers, reports, funding and investigator links",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Trial populations, centers, reports, funding and investigator links; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish separate recruitment populations from funding independence/replication scope"
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Was the fixed combination extended to single ingredients or other combinations?",
      "needed": "Direct finished-product, ingredient and formulation comparisons",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Direct finished-product, ingredient and formulation comparisons; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Preserve the applicability of the fixed-combination question"
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Does short-term use mean long-term adjunctive-care/disease-management benefit?",
      "needed": "Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish short-term use/tests/symptoms from gaps in long-term direct outcomes"
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are representative-trial funding, products, formulation development and employee authors distinguished?",
      "needed": "OmniActive support/manufacturing/supply/development/author relationships",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "OmniActive support/manufacturing/supply/development/author relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show support separately from manufacturing/development/employee relationships"
    },
    {
      "item_id": "N23",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are follow-up trial costs, publication fees, medical writing and editorial support separated?",
      "needed": "Item-specific OmniActive and Bausch + Lomb roles",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Item-specific OmniActive and Bausch + Lomb roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Record trial operating costs separately from writing/publication support"
    },
    {
      "item_id": "N24",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are follow-up employee authors and advisory-board relationships distinguished?",
      "needed": "Author-specific company, employment, advisory and contribution relationships",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Author-specific company, employment, advisory and contribution relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show employee relationships separately from advisory/individual roles"
    },
    {
      "item_id": "N25",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Were all analysis, data and publication controls described as verified?",
      "needed": "Trial-specific outsourced analysis, data rights, responsibility and publication roles",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Trial-specific outsourced analysis, data rights, responsibility and publication roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish known involvement from unverified roles"
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "What actual trial scope underlies safety-collection wording?",
      "needed": "Hematology, chemistry, vital signs, examinations, AEs and group-specific tables",
      "role": "Supplementary",
      "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Hematology, chemistry, vital signs, examinations, AEs and group-specific tables; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Distinguish safety-narrative scope from trial-specific observation denominators"
    },
    {
      "item_id": "N27",
      "question_type": "Supplementary harm evidence",
      "question": "Are long-term/rare harms and soybean-oil comparator safety verified?",
      "needed": "Long-term exposure, rare events and population/product-specific harms",
      "role": "Supplementary",
      "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Long-term exposure, rare events and population/product-specific harms; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Separate efficacy/use comparisons from long-term safety gaps"
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Is actual summary reading distinguished from unread external materials?",
      "needed": "Bibliography, preserved JSON, abstract, full text, registration and plan statuses",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "Bibliography, preserved JSON, abstract, full text, registration and plan statuses; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Show summary reading separately from material-specific external nonreading"
    },
    {
      "item_id": "N29",
      "question_type": "Comparative efficacy: finished product and selected endpoint",
      "question": "Are original subclaim/parent history, production and user review distinguished?",
      "needed": "KO/EN, axes, dates, corrections, original selection and freeze/application",
      "role": "Required",
      "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint",
      "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units",
      "criterion": "KO/EN, axes, dates, corrections, original selection and freeze/application; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification",
      "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.",
      "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.",
      "proposed_research": "Separate original verdict/corrections from condition freeze/application and user review"
    }
  ]
}