{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Immediate aflibercept with vision of 20/25 or better · Two-year vision loss — Evidence Check",
  "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 question and subclaim grade D",
      "needed": "Selected existing question, grade/note, parent context and presence of score/status/axes",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Selected original question, grade/note and parent context; presence of score, status and axes to connect materials needed for the selected question with the materials currently available.",
      "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 existing question, grade/note, parent context and presence of score/status/axes: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing 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": "Connect the original question to additional materials in proposed update research; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Diabetic macular edema with vision of 20/25 or better",
      "needed": "Baseline vision, disease/recruitment criteria and actual population",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Baseline vision, disease/recruitment criteria and actual population to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Baseline vision, disease/recruitment criteria and actual population must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP",
      "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": "Proposed follow-up research on applicability by vision and population criteria; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Immediate aflibercept strategy",
      "needed": "Drug, strategy and actual exposure in the initial intervention",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Drug, strategy and actual exposure in the initial intervention to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Drug, strategy and actual exposure in the initial intervention must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on the relationship between initial strategy and actual exposure; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Observation with rescue treatment when needed",
      "needed": "Actual comparator strategy, later treatment and exposure",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Actual comparator strategy, later treatment and exposure to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Actual comparator strategy, later treatment and exposure must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap 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": "Proposed follow-up research on the relationship between the comparator strategy and later treatment; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Initial laser strategy and three arms",
      "needed": "Population, later treatment and arm correspondence for the three initial strategies",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Population, later treatment and arm correspondence for the three initial strategies to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Population, later treatment and arm correspondence for the three initial strategies must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M08 Table 8.2.a, 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": "Proposed follow-up research on actual exposure and outcomes by initial strategy; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Original worsening criteria for rescue treatment",
      "needed": "Planned worsening, confirmation/visits and actual implementation",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Planned worsening, confirmation/visits and actual implementation to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Planned worsening, confirmation/visits and actual implementation must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP",
      "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": "Proposed follow-up research on the relationship between later-treatment rules and observed outcomes; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "34% with observation and 25% with laser",
      "needed": "Units, timing and denominators for starting actual rescue injections",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Units, timing and denominators for starting actual rescue injections to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Units, timing and denominators for starting actual rescue injections must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections 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": "Proposed follow-up research on actual exposure, burden and outcomes by strategy; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "91 sites and 702 participants/702 eyes",
      "needed": "People/eyes, sites and randomized denominators by arm",
      "role": "Required",
      "role_reason": "Preparation item distinguishing People/eyes, sites and randomized denominators by arm to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for People/eyes, sites and randomized denominators by arm must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; 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": "Proposed follow-up research on population/measurement units and site heterogeneity; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Web allocation, blocks and stratification",
      "needed": "Original sequence generation/concealment, stratification and actual procedure",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original sequence generation/concealment, stratification and actual procedure to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Original sequence generation/concealment, stratification and actual procedure must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP",
      "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": "Proposed follow-up research on the relationship between allocation procedure and actual groups; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Masking at annual vision examinations",
      "needed": "Role-specific measurement and masking for assessors, participants and investigators",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Role-specific measurement and masking for assessors, participants and investigators to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Role-specific measurement and masking for assessors, participants and investigators must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP",
      "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": "Proposed follow-up research on measurement/decision procedures and bias; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Two years, 104 weeks and the five-letter event",
      "needed": "Prespecified primary time point, vision-loss definition and unit",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Prespecified primary time point, vision-loss definition and unit to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Prespecified primary time point, vision-loss definition and unit must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary",
      "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": "Proposed follow-up research distinguishing event definitions/time points from other measures; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Two-year events and denominators by arm",
      "needed": "Original arm-specific events/observed denominators and analysis correspondence",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original arm-specific events/observed denominators and analysis correspondence to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Original arm-specific events/observed denominators and analysis correspondence must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on the relationship between observed and original analysis denominators; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Immediate injection versus observation: RR, CI and P",
      "needed": "Original estimate, precision, test and model for the selected comparison",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original estimate, precision, test and model for the selected comparison to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Original estimate, precision, test and model for the selected comparison must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on precision under the same estimate/comparison definition; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Original risk difference of −3 percentage points and interval",
      "needed": "Risk-difference units, comparison, interval and distinction from other estimates",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Risk-difference units, comparison, interval and distinction from other estimates to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Risk-difference units, comparison, interval and distinction from other estimates must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; 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": "Proposed follow-up research on uncertainty and meaning by estimate; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Nonsignificance, meaningful benefit and “the same”",
      "needed": "Prespecified important differences, precision and the original “same” wording",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Prespecified important differences, precision and the original “same” wording to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Prespecified important differences, precision and the original “same” wording must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; CHAMGAP adaptation; M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP",
      "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": "Proposed follow-up research distinguishing nonsignificance from important differences and uncertainty; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "ITT plan and multiple imputation",
      "needed": "Randomized eyes/original allocation, missing data and estimation model",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Randomized eyes/original allocation, missing data and estimation model to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Randomized eyes/original allocation, missing data and estimation model must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP",
      "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": "Proposed follow-up research on missing-data assumptions and assigned-strategy effects; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Registration, prespecified outcome and multiplicity",
      "needed": "Registration, protocol/SAP and specifications for three comparisons and time points",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Registration, protocol/SAP and specifications for three comparisons and time points to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Registration, protocol/SAP and specifications for three comparisons and time points must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research connecting prespecified specifications to outcome reporting; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Concurrent care and the nonstudy eye",
      "needed": "Distinguish original stratification from other exposure/care",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinguish original stratification from other exposure/care to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Distinguish original stratification from other exposure/care must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on concurrent exposure and attribution of strategy outcomes; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Public NEI and NIDDK funding",
      "needed": "Funding and roles in research, analysis and publication",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Funding and roles in research, analysis and publication to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Funding and roles in research, analysis and publication must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research distinguishing support roles from reporting relationships; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Regeneron drug donation and site costs",
      "needed": "Separate free product/site payments from other support",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Separate free product/site payments from other support to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Separate free product/site payments from other support must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on individual support and reporting relationships; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Company comments and Network control",
      "needed": "Protocol/manuscript comments and roles controlling conduct, analysis and submission",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Protocol/manuscript comments and roles controlling conduct, analysis and submission to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Protocol/manuscript comments and roles controlling conduct, analysis and submission must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research on declarations and actual role relationships; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Employee authors and COI gaps",
      "needed": "Author-specific affiliations/contributions, employment, equity and other relationships",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Author-specific affiliations/contributions, employment, equity and other relationships to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Author-specific affiliations/contributions, employment, equity and other relationships must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Proposed follow-up research distinguishing author relationships from support roles; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N23",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "ATC vascular events in people",
      "needed": "Harm definitions, arm-specific events/denominators and observation scope",
      "role": "Supplementary",
      "role_reason": "Preparation item distinguishing Harm definitions, arm-specific events/denominators and observation scope to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "Supplement gaps in safety materials for the selected subclaim. Do not judge safety from visual efficacy or parent safety wording, or generate harm incidence or new use instructions.",
      "criterion": "Original source materials and the relevant analysis scope for Harm definitions, arm-specific events/denominators and observation scope must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M19 §19.1.2–19.2.4; 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": "Proposed follow-up research on arm-specific harm observation and uncertainty; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N24",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Intraocular pressure and visit-related detection bias",
      "needed": "Pressure-outcome definitions/populations and visit/measurement differences",
      "role": "Supplementary",
      "role_reason": "Preparation item distinguishing Pressure-outcome definitions/populations and visit/measurement differences to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "Supplement gaps in safety materials for the selected subclaim. Do not judge safety from visual efficacy or parent safety wording, or generate harm incidence or new use instructions.",
      "criterion": "Original source materials and the relevant analysis scope for Pressure-outcome definitions/populations and visit/measurement differences must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4; 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": "Proposed follow-up research on monitoring frequency and harm detection; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Already impaired vision and separate trials",
      "needed": "Relationship between other vision populations/treatment trials and the selected strategy",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Relationship between other vision populations/treatment trials and the selected strategy to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Relationship between other vision populations/treatment trials and the selected strategy must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections 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": "Proposed follow-up research distinguishing baseline vision and treatment-strategy differences; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Protocol W: anatomy and vision",
      "needed": "Populations, anatomical/visual outcomes and timing in another trial",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Populations, anatomical/visual outcomes and timing in another trial to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Populations, anatomical/visual outcomes and timing in another trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections 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": "Proposed follow-up research on anatomical outcomes and vision/trial relationships; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "The same people/eyes, trial and reports",
      "needed": "Distinguish trials, reports, study eyes, arms, outcomes and independent replication",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinguish trials, reports, study eyes, arms, outcomes and independent replication to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Distinguish trials, reports, study eyes, arms, outcomes and independent replication must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; 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": "Proposed follow-up research distinguishing reused materials from separate evidence; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Other vision levels, durations and generalization",
      "needed": "Populations, durations and clinical outcomes outside the selected vision/strategy",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Populations, durations and clinical outcomes outside the selected vision/strategy to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Populations, durations and clinical outcomes outside the selected vision/strategy must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP",
      "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": "Proposed follow-up research distinguishing the selected question from other conditions; no new investigation, calculation or trial is performed here."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Original axes, Korean/English wording, dates and corrections",
      "needed": "Distinguish subclaim/parent verdicts, original values, dates/corrections and history",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinguish subclaim/parent verdicts, original values, dates/corrections and history to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Distinguish subclaim/parent verdicts, original values, dates/corrections and history must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Propose update research on source-material changes and production versions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Summary read; external material unread",
      "needed": "Actual reading, identity/URLs and additional-material gaps for each material",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Actual reading, identity/URLs and additional-material gaps for each material to connect materials needed for the selected question with the materials currently available.",
      "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 source materials and the relevant analysis scope for Actual reading, identity/URLs and additional-material gaps for each material must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; 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": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now."
    }
  ]
}