{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Valeda × Improved daily visual function and independence in dry AMD — Evidence check sheet",
  "language": "en",
  "translation_date": "2026-10-10",
  "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 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": "Efficacy comparison and presentation of stored material",
      "question": "What are the existing values for the daily visual-function and independence question?",
      "needed": "Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50 to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50 must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Record separate sources for the daily-function question and parent surrogate verdict. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What direct outcomes are needed for daily visual function and independent living?",
      "needed": "Clear patient-level measurement of reading, driving, daily function and independence",
      "role": "Required",
      "role_reason": "This item distinguishes Clear patient-level measurement of reading, driving, daily function and independence to link the materials needed for the selected question with those 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 materials and analysis scope covering Clear patient-level measurement of reading, driving, daily function and independence must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Provide separate endpoint materials for direct daily function and independence. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do statistically different BCVA results establish daily function?",
      "needed": "Distinguishing surrogates, direct function and between-arm estimands",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing surrogates, direct function and between-arm estimands to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing surrogates, direct function and between-arm estimands must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4; own boundary for extrapolation; M15 §15.3.1–15.3.3; own application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate surrogate and direct-outcome materials. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what reporting level was vision-related quality of life explored?",
      "needed": "Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link exploratory quality of life to prespecified primary time points. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are prespecified month-13/21 BCVA and month-24 reporting daily-function time points?",
      "needed": "Time-specific endpoints and actual functional-outcome periods/hierarchy",
      "role": "Required",
      "role_reason": "This item distinguishes Time-specific endpoints and actual functional-outcome periods/hierarchy to link the materials needed for the selected question with those 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 materials and analysis scope covering Time-specific endpoints and actual functional-outcome periods/hierarchy must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document periods and hierarchy for each endpoint. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were actual daily-life improvement values for reading and driving provided?",
      "needed": "Distinguishing illustrative activities from measured activity results/denominators",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing illustrative activities from measured activity results/denominators to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing illustrative activities from measured activity results/denominators must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate activity examples from measured direct results. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are independent living and blindness prevention direct results in these materials?",
      "needed": "Distinguishing independence/clinical events from the scope of BCVA",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing independence/clinical events from the scope of BCVA to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing independence/clinical events from the scope of BCVA must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4; own boundary for extrapolation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link direct clinical-event and surrogate materials. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which of 100 participants and 148 eyes is the daily-function denominator?",
      "needed": "Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document eye and patient-function denominators. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do 20 discontinuations relate to losses in daily-function data?",
      "needed": "Discontinued people, eyes/function responses, arms/time points and missingness",
      "role": "Required",
      "role_reason": "This item distinguishes Discontinued people, eyes/function responses, arms/time points and missingness to link the materials needed for the selected question with those 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 materials and analysis scope covering Discontinued people, eyes/function responses, arms/time points and missingness must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link trial discontinuation to losses in functional data. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were the actual population and baseline daily-function status?",
      "needed": "Dry AMD, 10 US centers, baseline vision/function and eligibility",
      "role": "Required",
      "role_reason": "This item distinguishes Dry AMD, 10 US centers, baseline vision/function and eligibility to link the materials needed for the selected question with those 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 materials and analysis scope covering Dry AMD, 10 US centers, baseline vision/function and eligibility must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link eligibility conditions to patient function. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the study-device, repeated-exposure and daily-function comparison terms?",
      "needed": "Original Valeda, historical repeated treatment, active sham and actual exposure",
      "role": "Required",
      "role_reason": "This item distinguishes Original Valeda, historical repeated treatment, active sham and actual exposure to link the materials needed for the selected question with those 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 materials and analysis scope covering Original Valeda, historical repeated treatment, active sham and actual exposure must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document device comparison and concomitant exposures. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were randomization and masking verified for functional-outcome measurement?",
      "needed": "2:1 allocation, double masking, patient responses, assessors and conditions",
      "role": "Required",
      "role_reason": "This item distinguishes 2:1 allocation, double masking, patient responses, assessors and conditions to link the materials needed for the selected question with those 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 materials and analysis scope covering 2:1 allocation, double masking, patient responses, assessors and conditions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link design to functional measurement. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which estimands and models were used for daily-function analysis?",
      "needed": "Patient scales/events, eye/repeated-observation structure, within/between arms and CI",
      "role": "Required",
      "role_reason": "This item distinguishes Patient scales/events, eye/repeated-observation structure, within/between arms and CI to link the materials needed for the selected question with those 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 materials and analysis scope covering Patient scales/events, eye/repeated-observation structure, within/between arms and CI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link endpoint-specific estimands and models. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does an unverified minimum important BCVA difference provide a functional threshold?",
      "needed": "Distinguishing surrogate importance, direct-function importance and statistical differences",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing surrogate importance, direct-function importance and statistical differences to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing surrogate importance, direct-function importance and statistical differences must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Provide materials for surrogate and functional importance separately. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does month-24 >5-letter loss in 7%/18% mean improved independent living?",
      "needed": "Distinguishing the original vision-loss threshold from direct daily-function events",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing the original vision-loss threshold from direct daily-function events to link the materials needed for the selected question with those 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 materials and analysis scope covering Distinguishing the original vision-loss threshold from direct daily-function events must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate vision-loss and direct-function materials. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do month-24 observations during repeated treatment differ from daily-function persistence after treatment?",
      "needed": "During/after exposure, beyond observation and long-term daily-life clinical outcomes",
      "role": "Required",
      "role_reason": "This item distinguishes During/after exposure, beyond observation and long-term daily-life clinical outcomes to link the materials needed for the selected question with those 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 materials and analysis scope covering During/after exposure, beyond observation and long-term daily-life clinical outcomes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document functional gaps by period and exposure phase. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are one report, eyes/time points and two tables new independent replications?",
      "needed": "The same LIGHTSITE III, 100 people and 148 eyes shared by two questions",
      "role": "Required",
      "role_reason": "This item distinguishes The same LIGHTSITE III, 100 people and 148 eyes shared by two questions to link the materials needed for the selected question with those 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 materials and analysis scope covering The same LIGHTSITE III, 100 people and 148 eyes shared by two questions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Record links among shared populations and repeated materials. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the scope of manufacturer support, NEI funding and five author relationships?",
      "needed": "Original company/public support, employees/consultants, roles and COI",
      "role": "Required",
      "role_reason": "This item distinguishes Original company/public support, employees/consultants, roles and COI to link the materials needed for the selected question with those 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 materials and analysis scope covering Original company/public support, employees/consultants, roles and COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Provide separate materials on support types and actual roles. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were daily-function registration and plans actually read?",
      "needed": "NCT04065490 identifier, functional hierarchy/multiplicity and versions",
      "role": "Required",
      "role_reason": "This item distinguishes NCT04065490 identifier, functional hierarchy/multiplicity and versions to link the materials needed for the selected question with those 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 materials and analysis scope covering NCT04065490 identifier, functional hierarchy/multiplicity and versions must be available, with unverified matters distinguished. Preserved statements are linked here; existing 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; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link registration versions to functional-endpoint plans. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are ocular AE/serious AE results measures of daily-life independence safety?",
      "needed": "25.8/25.5%, 7.5/5.5% and denominators/definitions/periods",
      "role": "Supplementary",
      "role_reason": "This item distinguishes 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods to link the materials needed for the selected question with those currently available.",
      "application_exception": "This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.",
      "criterion": "Original materials and analysis scope covering 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate safety events from direct daily-life outcomes. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Does no report of treatment-related serious events/phototoxicity mean no harms?",
      "needed": "Unreported signals, causality/collection/follow-up, long term and vulnerable populations",
      "role": "Supplementary",
      "role_reason": "This item distinguishes Unreported signals, causality/collection/follow-up, long term and vulnerable populations to link the materials needed for the selected question with those currently available.",
      "application_exception": "This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.",
      "criterion": "Original materials and analysis scope covering Unreported signals, causality/collection/follow-up, long term and vulnerable populations must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application; M19 §19.1.2–19.2.4; own application; Chamgap's own interpretation boundary. M19 principles inform this; no official causality tool was run",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document reported signals and unverified harms. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can results be generalized to other devices, diseases and daily-life support?",
      "needed": "Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope",
      "role": "Required",
      "role_reason": "This item distinguishes Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope to link the materials needed for the selected question with those 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 materials and analysis scope covering Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Document condition/device-specific functional gaps. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what level were the summary, external materials and hyperlinks actually read?",
      "needed": "Preserved summary, original paper URL/registration and unread/not-accessed status",
      "role": "Required",
      "role_reason": "This item distinguishes Preserved summary, original paper URL/registration and unread/not-accessed status to link the materials needed for the selected question with those 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 materials and analysis scope covering Preserved summary, original paper URL/registration and unread/not-accessed status must be available, with unverified matters distinguished. Preserved statements are linked here; existing 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 preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Record acquisition/reading status and versions by material. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are original subclaim ?, parent C50, Korean/English texts and corrections/empty values preserved?",
      "needed": "Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators",
      "role": "Required",
      "role_reason": "This item distinguishes Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators to link the materials needed for the selected question with those 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 materials and analysis scope covering Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules 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 preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Link original versions/dates to the subclaim functional question. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are condition/table production and user review separate events?",
      "needed": "Condition preservation, freezing, separate application, case production and incomplete review",
      "role": "Required",
      "role_reason": "This item distinguishes Condition preservation, freezing, separate application, case production and incomplete review to link the materials needed for the selected question with those 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 materials and analysis scope covering Condition preservation, freezing, separate application, case production and incomplete review must be available, with unverified matters distinguished. Preserved statements are linked here; existing 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 preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Record condition/production versions and user-change history. No new research, calculation or trial was performed."
    }
  ]
}