{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2935-s1",
  "verdict_number": "2935",
  "title": "Valeda × Improved daily visual function and independence in dry AMD — Evidence check sheet",
  "view_version": "1.0",
  "view_created_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "The same LIGHTSITE III patients/eyes with dry AMD; analyzed people/denominators for daily function remain unverified",
    "intervention": "Original historical Valeda/sham study conditions; not individual daily-life/device-use instructions",
    "dose": null,
    "comparator": "A direct function/independence question separate from original BCVA materials in the sham comparison",
    "endpoint": "Daily visual function and independent living distinguished from exploratory quality of life and the BCVA surrogate",
    "duration": "Actual periods for direct function/independence remain unverified; BCVA time points are not transferred",
    "excluded_extensions": [
      "Repurposing BCVA letters, statistical P or the original approximate 3.8-letter difference as direct effects on reading, driving, independent living or blindness prevention",
      "Promoting exploratory quality-of-life wording to a prespecified primary outcome, confirmed function or quantitative values",
      "Changing prespecified month-13/21 BCVA time points to month 24 or daily-function primary time points, or filling absent month-13 values with another time point",
      "Repurposing each arm's month-21 CI as a between-arm-difference CI, a month-24 CI or a daily-function interval",
      "Calculating new differences, rates, effects, CI or hypothetical values from original +6.2/+2.4, +5.6/+1.3, approximate 3.8, CI or P",
      "Filling an unverified prespecified minimum important letter difference with a new threshold, or repurposing >5-letter loss in 7%/18% as important benefit or daily-function response rates",
      "Recalculating 100 people and 148 eyes, or 20 discontinuations/original 20% attrition, into arm/time-specific analysis denominators, daily-function response denominators or unique participants",
      "Adding bilateral eyes, repeated time points/arms, related tables/outcomes or one report as new independent trials or participants",
      "Repurposing comparison with active low-fluence sham as efficacy versus no treatment or other devices",
      "Converting manufacturer/NEI support and five employee-or-consultant authors into free-device provision, individual roles, complete COI or independence certification",
      "Repurposing original ocular AE/serious AE and absence of reported related serious events/phototoxicity as overall safety, zero risk or other-device/long-term safety",
      "Extending original month-24 results during repeated exposure to effects after treatment ends, lifetime effects or clinical efficacy under other conditions/devices",
      "Inheriting parent C50/axes, historical cross-validation or original-material review wording as subclaim ? grade/score, current content review or external reading",
      "New clinical research, numerical calculations, hypothetical quantitative examples, new effects/CI/grades/independence certification, or treatment/device-setting/administration/daily-rehabilitation/driving/treatment-replacement instructions"
    ]
  },
  "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The selected existing question is improved daily visual function and independence, with original grade ? and a note that it was not the primary endpoint and remains unestablished. It is separate from the parent's BCVA C50 and original axes; subclaim score, status and axes are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new grade, score or effect is assigned to daily function. Existing content review remains incomplete.",
      "missingness": "No new grade, score or effect is assigned to daily function.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Relevant direct materials or user comments"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original counterview states that improvement of a few chart letters is not the same as improved reading, driving or independent living. Eye-specific BCVA results are not transferred to patients' daily-life outcomes.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Definitions, measures, periods, events/denominators and between-arm values for each function/independence outcome remain unverified. Existing content review remains incomplete.",
      "missingness": "Definitions, measures, periods, events/denominators and between-arm values for each function/independence outcome remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct function/independence outcomes, measures and prespecified plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Month 21 +6.2 versus +2.4 letters, P=.0036, and month 24 +5.6 versus +1.3, P=.0024, are original BCVA results. They are not converted into daily-function/independence values, risks or differences; original subclaim ? is preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Patient-level surrogate linkage, between-arm function values/CI and clinical importance remain unverified. Existing content review remains incomplete.",
      "missingness": "Patient-level surrogate linkage, between-arm function values/CI and clinical importance remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct function results and BCVA/function linkage materials"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original Korean counterview states that vision-related quality of life was also explored while BCVA was primary. Exploratory wording is not promoted to prespecified functional confirmation or quality-of-life benefit.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Measures/items, time points, denominators, values/CI/P, multiplicity and prespecification remain unverified. Existing content review remains incomplete.",
      "missingness": "Measures/items, time points, denominators, values/CI/P, multiplicity and prespecification remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original quality-of-life tables, measures/items and prespecified plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The prespecified primary time points at months 13 and 21 concern BCVA change, and month-24 reporting also contains original BCVA values. They are not automatically transferred to daily-function/independence measurements over the same period or to primary functional endpoints.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Functional-outcome time points/follow-up, prespecified analysis hierarchy and long-term periods remain unverified. Existing content review remains incomplete.",
      "missingness": "Functional-outcome time points/follow-up, prespecified analysis hierarchy and long-term periods remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Functional time points/follow-up and original registration/protocol/SAP"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript mentions reading and driving as examples of daily-life outcomes different from BCVA. They are not written as verified activity measurements or improvement percentages.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Activity conditions, functional measurement, denominators, follow-up and between-arm results/CI remain unverified. Existing content review remains incomplete.",
      "missingness": "Activity conditions, functional measurement, denominators, follow-up and between-arm results/CI remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Activity-specific direct outcomes and original measures/plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original advertising interpretation states that chart scores should not be extended to blindness prevention or improved independent living. No new statement is made that independent-living status or blindness events were collected.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Direct event definitions, person/time denominators, follow-up/censoring and original between-arm intervals remain unverified. Existing content review remains incomplete.",
      "missingness": "Direct event definitions, person/time denominators, follow-up/censoring and original between-arm intervals remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "When direct independent-living/clinical-event outcomes are supplied"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original randomized denominators of 100 people and 148 eyes refer to people/eyes in the BCVA trial. The 148 eyes are not repurposed as independent-living participants, and each eye/time point is not counted as a new person.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Daily-function questionnaire respondents/analyzed people, bilateral-eye/time-point correspondence and arm-specific denominators remain unverified. Existing content review remains incomplete.",
      "missingness": "Daily-function questionnaire respondents/analyzed people, bilateral-eye/time-point correspondence and arm-specific denominators remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Functional responses/analysis populations and eye/person linkage tables"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "20 discontinuations among 100 participants and original 20% attrition are trial context. These are not assumed to mean 20 missing daily-function responses or a remaining response count; no new completion proportion is calculated.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Missing functional responses, discontinuation arms/time points/reasons and imputation/follow-up remain unverified. Existing content review remains incomplete.",
      "missingness": "Missing functional responses, discontinuation arms/time points/reasons and imputation/follow-up remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Functional response/discontinuation flow and missingness/analysis plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original population was 100 people with dry AMD at 10 US centers. Baseline reading, driving, independence, disease stage and acuity conditions are not arbitrarily filled in.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Baseline functional limitations, exact stage/age, inclusion/exclusion and representativeness for other populations remain unverified. Existing content review remains incomplete.",
      "missingness": "Baseline functional limitations, exact stage/age, inclusion/exclusion and representativeness for other populations remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline function/disease tables, eligibility/exclusions and recruitment materials"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original Valeda multiwavelength, repeated study exposure and active low-fluence sham are preserved. These conditions are not converted into administration instructions for daily-life rehabilitation or independence treatment.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual exposure/adherence during function measurement, comparator conditions and concomitant treatment/aids/rehabilitation remain unverified. Existing content review remains incomplete.",
      "missingness": "Actual exposure/adherence during function measurement, comparator conditions and concomitant treatment/aids/rehabilitation remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual exposure, shared/arm-specific concomitant support and plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original trial was a 2:1 randomized, double-masked sham comparison. This is not inherited as verified functional-scale assessors/response methods, allocation awareness or maintenance of masking.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Allocation unit/concealment, functional-assessment masking/awareness and assessment environment remain unverified. Existing content review remains incomplete.",
      "missingness": "Allocation unit/concealment, functional-assessment masking/awareness and assessment environment remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation/masking and functional-assessment instructions/data"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original approximate 3.8-letter between-arm LS difference concerns month-21 BCVA. It is not repurposed as a quality-of-life/independence scale score, probability or daily-improvement CI.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Original functional analysis/adjustment, models/repetition, prespecified contrasts, CI/P and denominators remain unverified. Existing content review remains incomplete.",
      "missingness": "Original functional analysis/adjustment, models/repetition, prespecified contrasts, CI/P and denominators remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original function tables, measures/models and SAP"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "An original prespecified minimum important BCVA letter difference was not identified. Statistical BCVA differences, a few letters or an unverified prespecified threshold are not used to create daily-function important differences or responder criteria.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Prespecified minimum important differences, intervals, response criteria and validation for functional measures remain unverified. Existing content review remains incomplete.",
      "missingness": "Prespecified minimum important differences, intervals, response criteria and validation for functional measures remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Functional-importance definitions, prespecified plans and original intervals"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original month-24 BCVA loss of more than 5 letters in 7%/18% is a vision-loss result. It is not converted into an independent-living maintenance rate, blindness/activity-improvement percentage or minimum important functional difference.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original loss denominators/CI, prespecified hierarchy and individual linkage to daily-life status remain unverified. Existing content review remains incomplete.",
      "missingness": "Original loss denominators/CI, prespecified hierarchy and individual linkage to daily-life status remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original loss tables/denominators, functional results and prespecified plans"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original treatment repeated every 4 months and month-24 BCVA reporting are preserved. These are not extended to daily-life benefit after treatment, lifelong independence or effects under other schedules/devices.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Functional/independence follow-up after exposure ends and long-term clinical events remain unverified. Existing content review remains incomplete.",
      "missingness": "Functional/independence follow-up after exposure ends and long-term clinical events remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exposure/follow-up endpoints and long-term functional materials"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "This table and the BCVA table share the same preserved summary, LIGHTSITE III month-24 report and patients/eyes. 1 bibliography entry, repeated time points/eyes and two endpoints are not added as new independent trials or participants.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unique clinical trial, participant and independent-replication totals are not certified and remain unrecorded. Existing content review remains incomplete.",
      "missingness": "Unique clinical trial, participant and independent-replication totals are not certified and remain unrecorded.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "When report/trial/patient/eye/follow-up relationships are supplied"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original LumiThera+NEI1R43EY025508-03 and 5 employee-or-consultant authors are preserved. Individual relationships/roles are not newly assigned, and public support alone does not establish independence.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Contracts/individual-author COI, analysis/writing roles, free devices and publication authority remain unverified. Existing content review remains incomplete.",
      "missingness": "Contracts/individual-author COI, analysis/writing roles, free devices and publication authority remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original support/contribution/COI and product/data-rights contracts"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original NCT04065490 is preserved and distinguished from prespecified month-13/21 BCVA wording. The registration number is not used as prespecified confirmation of daily function or reading of protocol/SAP.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Functional prespecification/time points, multiplicity, amendment history and SAP remain unread. Existing content review remains incomplete.",
      "missingness": "Functional prespecification/time points, multiplicity, amendment history and SAP remain unread.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration/protocol/SAP copies or user materials"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original ocular AE 25.8%/25.5% and serious ocular AE 7.5%/5.5% are separate safety results. They are not converted into daily-function/independence improvement or certification of safe device use.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Event counts/denominators, eyes/people, collection/periods/omissions and CI remain unverified. Existing content review remains incomplete.",
      "missingness": "Event counts/denominators, eyes/people, collection/periods/omissions and CI remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Safety tables, collection/exposure/follow-up and denominators"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original wording that treatment-related serious adverse events and phototoxicity signals were not reported is preserved. It is not extended to zero risk, overall safety, long-term independence or other-device safety.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Relatedness adjudication, long-term/vulnerable populations, omissions and precision remain unverified. Existing content review remains incomplete.",
      "missingness": "Relatedness adjudication, long-term/vulnerable populations, omissions and precision remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Safety collection/adjudication and long-term materials"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The selected daily-function question concerns gaps in the original Valeda dry-AMD trial. No instructions are written for other light devices/diseases, driving permission, independent-living rehabilitation, administration or treatment replacement.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct daily-life/clinical results and separate independent materials under other conditions remain unverified. Existing content review remains incomplete.",
      "missingness": "Direct daily-life/clinical results and separate independent materials under other conditions remain unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "When condition-specific direct materials are supplied"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The complete preserved summary was read for production and labeled summary read; the original PMID41791029 URL is preserved. External papers, registration/plans and COI remain unread; the historical work did not test external-link operation, papers or tables.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External clinical-material access, abstract/full-text/plan reading and paper comparison were not performed in the recorded work. Existing content review remains incomplete.",
      "missingness": "External clinical-material access, abstract/full-text/plan reading and paper comparison were not performed in the recorded work.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "User-supplied materials and actual reading records"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The complete preserved summary's parent C50/Caution, Korean/English texts, original axes, unrecorded/false values, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim ? grade/note and absent score/status/axes are not filled with parent C50 or D.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, grade changes, verdict-manuscript translation, clinical-original review, corrections and external updating were not performed. Existing content review remains incomplete.",
      "missingness": "At original authoring, grade changes, verdict-manuscript translation, clinical-original review, corrections and external updating were not performed.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original correction materials or user comments"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Condition preservation, freezing, separate application, case production and content review are separate records. Existing content review remains incomplete; production-entry counts do not establish completed clinical review or unique clinical trial/participant totals.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Existing content review remains incomplete. At original authoring, self/peer review, tests and screen/link checks were not performed. Existing content review remains incomplete.",
      "missingness": "Existing content review remains incomplete. At original authoring, self/peer review, tests and screen/link checks were not performed.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "User review feedback and additional preserved materials"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "LIGHTSITE III month-24 report",
      "url": "https://pubmed.ncbi.nlm.nih.gov/41791029/",
      "report_type": "Double-masked, sham-controlled multicenter randomized trial",
      "existence": "Stored bibliography exists; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "study_family": "RG2935-LIGHTSITE-III",
      "independent_replication": null,
      "observed_result": "The original Korean counterview states that vision-related quality of life was also explored, but BCVA was primary. The subclaim note states that daily visual function/independence was not the primary endpoint and remains unestablished. Statistical month-21/24 BCVA differences and >5-letter loss in 7%/18% are not direct daily-life/independence values. Functional measures, values/CI/P, prespecified hierarchy and denominators/periods remain unverified; no new effect or verdict is created.",
      "result_level": "Outcome wording in the stored summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Stored file",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review."
        },
        {
          "material_type": "External paper",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Registration material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Protocol",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/41791029/"
        }
      ]
    }
  ],
  "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "S01 LIGHTSITE III month-24 report/Jaffe 2026 PMID41791029 is the same report of a 2:1 randomized, double-masked active-sham comparison at 10 US centers involving 100 people and 148 eyes. Prespecified month-13/21 BCVA, original month-21/24 values and 20 discontinuations are distinguished. This table and its related table, patients/eyes/arms, repeated time points and outcomes are not added as new independent trials or participants. Unique clinical totals are unrecorded; counts of material/report entries are not clinical independence totals."
  },
  "history": [
    {
      "date": "2026-10-10",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}