{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Lutein, zeaxanthin, curcumin, and vitamin D3 combination capsule × Improved day-56 tear volume and OSDI",
  "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected day-56 coprimary results and original values",
      "needed": "Original question, grade/note, parent context and absent fields",
      "role": "Required",
      "role_reason": "Distinguish Original question, grade/note, parent context and absent fields to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original question, grade/note, parent context and absent fields requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update research linking the original question with additional material; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Population with mild-to-moderate dry eye",
      "needed": "Recruitment, disease/baseline conditions and group characteristics",
      "role": "Required",
      "role_reason": "Distinguish Recruitment, disease/baseline conditions and group characteristics to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Recruitment, disease/baseline conditions and group characteristics requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Further research on population-specific applicability and heterogeneity; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Fixed four-ingredient combination capsule",
      "needed": "Ingredient combination, formulation/dose and product identity",
      "role": "Required",
      "role_reason": "Distinguish Ingredient combination, formulation/dose and product identity to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Ingredient combination, formulation/dose and product identity requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing combination formulation from attribution of results; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Visually matched soybean-oil placebo",
      "needed": "Comparator formulation, sensory matching and concurrent exposure",
      "role": "Required",
      "role_reason": "Distinguish Comparator formulation, sensory matching and concurrent exposure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Comparator formulation, sensory matching and concurrent exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing comparator and measurement-condition differences; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Day-56/eight-week exposure and follow-up",
      "needed": "Distinguish exposure period, visits/measurement and actual completion",
      "role": "Required",
      "role_reason": "Distinguish Distinguish exposure period, visits/measurement and actual completion to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish exposure period, visits/measurement and actual completion requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research on periods, timing and durability; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Randomization and blinding procedures",
      "needed": "Allocation/concealment and participant, measurement, assessment and analysis roles",
      "role": "Required",
      "role_reason": "Distinguish Allocation/concealment and participant, measurement, assessment and analysis roles to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Allocation/concealment and participant, measurement, assessment and analysis roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on relationships between procedures and observed results; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "2021: 60 randomized and 59 complete cases",
      "needed": "Randomized/observed/analyzed denominators, omissions and missingness",
      "role": "Required",
      "role_reason": "Distinguish Randomized/observed/analyzed denominators, omissions and missingness to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Randomized/observed/analyzed denominators, omissions and missingness requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Further research on complete-case selection and omission assumptions; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Original baseline and final OSDI values",
      "needed": "Group OSDI timing, units, estimates and variability",
      "role": "Required",
      "role_reason": "Distinguish Group OSDI timing, units, estimates and variability to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Group OSDI timing, units, estimates and variability requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on baseline/final values, changes and between-group estimates; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "OSDI between-group P value and precision",
      "needed": "Selected between-group estimate/CI, test and model",
      "role": "Required",
      "role_reason": "Distinguish Selected between-group estimate/CI, test and model to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Selected between-group estimate/CI, test and model requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing precision from clinical meaning; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Schirmer tear volume and measurement",
      "needed": "Tear-volume definition/units, test conditions and assessed eyes",
      "role": "Required",
      "role_reason": "Distinguish Tear-volume definition/units, test conditions and assessed eyes to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Tear-volume definition/units, test conditions and assessed eyes requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing objective tests from symptom outcomes; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Coprimary outcomes, multiplicity and hierarchy",
      "needed": "Success rules for two prespecified endpoints and multiple comparisons/time points",
      "role": "Required",
      "role_reason": "Distinguish Success rules for two prespecified endpoints and multiple comparisons/time points to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Success rules for two prespecified endpoints and multiple comparisons/time points requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing prospective hierarchy from selected outcomes; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "CIs and prespecified importance thresholds",
      "needed": "Separate evidence for group CIs and clinical importance",
      "role": "Required",
      "role_reason": "Distinguish Separate evidence for group CIs and clinical importance to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Separate evidence for group CIs and clinical importance requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on statistical results, important differences and uncertainty; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "2024: four centers, 155 randomized and 116 analyzed",
      "needed": "Follow-up-trial population, denominators, analysis and exclusions",
      "role": "Required",
      "role_reason": "Distinguish Follow-up-trial population, denominators, analysis and exclusions to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Follow-up-trial population, denominators, analysis and exclusions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap-designed; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on analysis populations, omissions and follow-up results; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "2024 Schirmer/OSDI",
      "needed": "Original group results for each measure and correspondence to its trial",
      "role": "Required",
      "role_reason": "Distinguish Original group results for each measure and correspondence to its trial to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original group results for each measure and correspondence to its trial requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing formulation-specific measures and populations; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Artificial-tear use: P=.562, a separate outcome",
      "needed": "Use-outcome definition/timing, denominators and estimates",
      "role": "Required",
      "role_reason": "Distinguish Use-outcome definition/timing, denominators and estimates to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Use-outcome definition/timing, denominators and estimates requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing other outcomes from uncertainty; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "CTRI and NCT registration records",
      "needed": "Trial registration, original plans/changes and report correspondence",
      "role": "Required",
      "role_reason": "Distinguish Trial registration, original plans/changes and report correspondence to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Trial registration, original plans/changes and report correspondence requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research connecting prospective plans to reports; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Concurrent eye care and adherence",
      "needed": "Artificial tears/treatment, lifestyle/products and actual exposure",
      "role": "Required",
      "role_reason": "Distinguish Artificial tears/treatment, lifestyle/products and actual exposure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Artificial tears/treatment, lifestyle/products and actual exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on concurrent exposure and attribution of blend results; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "2021 support, product supply and development",
      "needed": "Distinguish research funding, manufacturing/supply, development and other support",
      "role": "Required",
      "role_reason": "Distinguish Distinguish research funding, manufacturing/supply, development and other support to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish research funding, manufacturing/supply, development and other support requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on individual support/roles and report relationships; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "2021: four employee authors",
      "needed": "Author-specific employment/affiliation, contributions and COI",
      "role": "Required",
      "role_reason": "Distinguish Author-specific employment/affiliation, contributions and COI to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Author-specific employment/affiliation, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on author relationships and results-reporting roles; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "2024 trial funding and publication/writing support",
      "needed": "Institution-specific trial/publication, writing and editorial roles",
      "role": "Required",
      "role_reason": "Distinguish Institution-specific trial/publication, writing and editorial roles to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Institution-specific trial/publication, writing and editorial roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on individual support and report relationships; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "2024 employees and advisory-board members",
      "needed": "Author/institution employment, advisory roles, contributions and COI",
      "role": "Required",
      "role_reason": "Distinguish Author/institution employment, advisory roles, contributions and COI to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Author/institution employment, advisory roles, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on individual author/institution relationships and reports; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Same company lineage and independence",
      "needed": "Distinguish two trials/reports, company development/funding and replication",
      "role": "Required",
      "role_reason": "Distinguish Distinguish two trials/reports, company development/funding and replication to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish two trials/reports, company development/funding and replication requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M04 §§4.6.1–4.6.2 and M15 §15.3.1; Chamgap adaptation; Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing shared material/company lineage from separate replication; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "People/eyes, measures and timing totals",
      "needed": "Report-trial-person/eye-endpoint duplication and relationships",
      "role": "Required",
      "role_reason": "Distinguish Report-trial-person/eye-endpoint duplication and relationships to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Report-trial-person/eye-endpoint duplication and relationships requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on measurement/reporting units and actual population relationships; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N24",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Harm collection and nonreporting scope",
      "needed": "Safety populations, collection/examinations and group events/denominators",
      "role": "Supplementary",
      "role_reason": "Distinguish Safety populations, collection/examinations and group events/denominators to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Supplement safety-material gaps for the selected subclaim. Do not judge safety from detection, tear/symptom results or parent safety wording, or generate harm rates or new use instructions.",
      "criterion": "Safety populations, collection/examinations and group events/denominators requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research on harm-reporting scope and later follow-up material; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Durability, individual ingredients and other formulations",
      "needed": "Application outside the selected blend, population and period",
      "role": "Required",
      "role_reason": "Distinguish Application outside the selected blend, population and period to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Application outside the selected blend, population and period requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §3.2.4; Chamgap extension boundary; M03 §3.2.1; detailed population conditions are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing combined attribution from other conditions; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Original axes, Korean/English text, dates and corrections",
      "needed": "Distinguish subclaim/parent values, dates/corrections and history",
      "role": "Required",
      "role_reason": "Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research updating original-material changes and production versions; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Summary read; external material unread",
      "needed": "Material-specific actual reading, bibliography/URLs and additional-material gaps",
      "role": "Required",
      "role_reason": "Distinguish Material-specific actual reading, bibliography/URLs and additional-material gaps to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Material-specific actual reading, bibliography/URLs and additional-material gaps requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Scope-specific update research based on material actually acquired; no new search, calculation or trial was performed here."
    }
  ]
}
