{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2935-s0",
  "verdict_number": "2935",
  "title": "Valeda × Improved ETDRS best-corrected visual-acuity letters 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": "LIGHTSITE III: 100 people and 148 eyes with dry AMD at 10 US centers; exact baseline/eligibility conditions unverified",
    "intervention": "Original Valeda multiwavelength, repeated study exposure; not device-use instructions",
    "dose": null,
    "comparator": "Active sham delivering low-fluence light; not repurposed as an untreated comparator",
    "endpoint": "ETDRS best-corrected visual-acuity letter change; prespecified months 13/21 distinguished from month-24 reporting",
    "duration": "Prespecified BCVA time points at months 13 and 21; original month-21/24 values and observations during/after repeated exposure distinguished",
    "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 ?/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": "How does the selected BCVA question differ from the parent verdict?",
      "needed": "Separating subclaim C grade, note and absent values from parent C50, axes and original verdict",
      "role": "Required",
      "role_reason": "This item distinguishes Separating subclaim C grade, note and absent values from parent C50, axes and original verdict 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 Separating subclaim C grade, note and absent values from parent C50, axes and original verdict 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: Separate sources for the original question and verdict context. 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 ETDRS best-corrected visual-acuity letters, with original C grade and note but no score, status or axes. Parent C50, Caution and original axes such as S/R1/I0/E+/B2 remain parent context.",
      "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. Absent subclaim score, status and axes are not filled with parent values, and no new grade is written. Existing content review remains incomplete.",
      "missingness": "Absent subclaim score, status and axes are not filled with parent values, and no new grade is written.",
      "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": "Additional selected materials or user comments"
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were LIGHTSITE III's actual population and recruitment conditions?",
      "needed": "Ten US centers, dry AMD, baseline acuity/stage and selection criteria",
      "role": "Required",
      "role_reason": "This item distinguishes Ten US centers, dry AMD, baseline acuity/stage and selection criteria 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 Ten US centers, dry AMD, baseline acuity/stage and selection criteria 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 BCVA materials by population conditions. 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 included 100 people with dry age-related macular degeneration at 10 US centers. Results are not extended to wet AMD, other acuity levels or stages, or other devices.",
      "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. Exact stage, baseline BCVA, age/comorbidities, selection/exclusions and representativeness remain unverified. Existing content review remains incomplete.",
      "missingness": "Exact stage, baseline BCVA, age/comorbidities, selection/exclusions and representativeness 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": "Eligibility/exclusions, baseline tables and recruitment flow"
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were the historical Valeda and sham study exposures?",
      "needed": "Distinguishing original wavelengths, sessions/duration, repetition and comparator",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing original wavelengths, sessions/duration, repetition and comparator 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 original wavelengths, sessions/duration, repetition and comparator 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: Distinguish device study conditions from actual exposure. 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": "Valeda study conditions used 590, 660 and 850 nm light, with 9 sessions over 3~5 weeks repeated every 4 months. The sham was an active comparator delivering low-fluence light. These are not converted into device-use, setting or administration instructions.",
      "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 light dose, arm-specific exposure/adherence, device standardization, stopping/changes and concomitant-treatment details remain unverified. Existing content review remains incomplete.",
      "missingness": "Actual light dose, arm-specific exposure/adherence, device standardization, stopping/changes and concomitant-treatment details 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/adherence, comparator/device records and protocol"
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What units and procedures underlie 2:1 randomization and double masking?",
      "needed": "100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships",
      "role": "Required",
      "role_reason": "This item distinguishes 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships 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 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; own application; 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: Document allocation units and arm/center structure. 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": "LIGHTSITE III is described as a double-masked sham-controlled trial randomizing 100 participants and 148 eyes 2:1. Arm-specific people/eye counts and allocation units are not newly 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. Person/eye allocation unit, same-arm handling of bilateral eyes, sequence generation/concealment and maintenance of masking remain unverified. Existing content review remains incomplete.",
      "missingness": "Person/eye allocation unit, same-arm handling of bilateral eyes, sequence generation/concealment and maintenance of masking 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 records, arm-specific people/eye tables and protocol"
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What denominators do 100 participants and 148 eyes represent?",
      "needed": "Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points 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 people, eyes, bilateral participation, analysis populations and repeated time points 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: Link participant and eye 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": "100 participants and 148 eyes are the original randomized denominators. People are not converted into eyes, 148 independent participants or the analyzed eyes at every time point.",
      "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. People, eyes and observed/analyzed denominators by arm/time point, and handling of bilateral-eye correlation, remain unverified. Existing content review remains incomplete.",
      "missingness": "People, eyes and observed/analyzed denominators by arm/time point, and handling of bilateral-eye correlation, 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": "People/eye flow and analysis-population tables by arm/time point"
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What observation losses do 20 discontinuations and original 20% attrition represent?",
      "needed": "Discontinued participants, time points/arms/eyes and missingness",
      "role": "Required",
      "role_reason": "This item distinguishes Discontinued participants, time points/arms/eyes 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 participants, time points/arms/eyes 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 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: Link discontinued participants/eyes to analysis 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 of 100 participants discontinued, and the original verdict describes 20% attrition. No remaining participant/eye counts, time-specific attrition rates or discontinuation reasons are calculated or 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. Discontinuations, eye counts, reasons, missing outcomes and analysis/imputation methods by arm/time point remain unverified. Existing content review remains incomplete.",
      "missingness": "Discontinuations, eye counts, reasons, missing outcomes and analysis/imputation methods by arm/time point 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": "Participant flow, discontinuations by arm/time point and missing-data handling"
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do prespecified primary time points at months 13 and 21 differ from the month-24 report?",
      "needed": "Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity",
      "role": "Required",
      "role_reason": "This item distinguishes Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity 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 prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity 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 result adaptation is our own design; M08 Table 8.2.a, 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 prespecified time points to reporting/follow-up 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 wording identifies months 13 and 21 as prespecified primary BCVA time points. Month-21 and month-24 BCVA values are preserved, without promoting month 24 to a prespecified primary time point.",
      "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. Joint hierarchy for months 13/21, prespecified/follow-up status of month 24 and multiple-testing plans remain unverified. Existing content review remains incomplete.",
      "missingness": "Joint hierarchy for months 13/21, prespecified/follow-up status of month 24 and multiple-testing plans 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": "Registration/protocol/SAP, time-point hierarchy and original result tables"
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were month-21 PBM and sham changes and intervals?",
      "needed": "Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P",
      "role": "Required",
      "role_reason": "This item distinguishes Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P 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 LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P 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 internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; 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: Document within-arm changes and between-arm comparison intervals. 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 PBM +6.2 letters (95% CI 4.2~8.2), sham +2.4 (−.1~4.9), and between-arm P=.0036 are preserved. Arm-specific change CI are not transferred to a between-arm-difference CI.",
      "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. Analyzed eyes/people by arm, exact between-arm-difference CI, adjustment/missingness and change baseline remain unverified. Existing content review remains incomplete.",
      "missingness": "Analyzed eyes/people by arm, exact between-arm-difference CI, adjustment/missingness and change baseline 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 LS mean/difference, CI and denominator/model tables"
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the approximate 3.8-letter between-arm difference an original manuscript value?",
      "needed": "Distinguishing the original approximate 3.8 LS difference from arm changes and importance",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing the original approximate 3.8 LS difference from arm changes and importance 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 approximate 3.8 LS difference from arm changes and importance 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 the original difference to interval and importance definitions. 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 describes an approximate 3.8-letter between-arm LS mean difference at month 21. This original value is preserved; no new difference is calculated from +6.2/+2.4, and no exact CI or clinical-importance threshold is produced.",
      "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. The original difference CI, model/rounding, denominators and prespecified importance threshold remain unverified. Existing content review remains incomplete.",
      "missingness": "The original difference CI, model/rounding, denominators and prespecified importance threshold 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 between-arm difference table, model and importance definition"
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which analysis produced month-24 changes and P?",
      "needed": "+5.6/+1.3, P=.0024 and time-point/denominator/hierarchy",
      "role": "Required",
      "role_reason": "This item distinguishes +5.6/+1.3, P=.0024 and time-point/denominator/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 +5.6/+1.3, P=.0024 and time-point/denominator/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 result adaptation is our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, 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: Document time-specific estimands and analysis populations. 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-24 PBM +5.6 versus sham +1.3 letters, P=.0024, are recorded as in the original materials. They are not pooled with month 21 or used to create a new mean/difference or another trial.",
      "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. Month-24 arm-specific/between-arm CI, denominators, model/missingness and prespecified hierarchy remain unverified. Existing content review remains incomplete.",
      "missingness": "Month-24 arm-specific/between-arm CI, denominators, model/missingness and prespecified hierarchy 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 month-24 results/denominators/model and analysis plan"
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does this summary contain results for the month-13 primary time point?",
      "needed": "The original month-13 primary time point and gaps in actual values/denominators",
      "role": "Required",
      "role_reason": "This item distinguishes The original month-13 primary time point and gaps in actual values/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 The original month-13 primary time point and gaps in actual values/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 result adaptation is our own design; M08 Table 8.2.a, 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 results and omissions at each prespecified time point. 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 endpoint is BCVA change at months 13 and 21, but this preserved summary's quantitative reports concern months 21 and 24. Month-13 values, CI or P are not filled with values from other time points.",
      "condition_status": "Unverified",
      "status_reason": "Required information is unverified in the preserved summary. Month-13 BCVA values, denominators, analysis/missingness and reporting hierarchy remain unverified in the preserved summary. Existing content review remains incomplete.",
      "missingness": "Month-13 BCVA values, denominators, analysis/missingness and reporting hierarchy remain unverified in the preserved summary.",
      "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 month-13 result table and time-specific plans"
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is a statistically significant letter difference clinically important?",
      "needed": "Distinguishing prespecified minimum important BCVA difference, precision and patient function",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing prespecified minimum important BCVA difference, precision and patient function 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 prespecified minimum important BCVA difference, precision and patient function 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: Link statistical significance/precision to importance. 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-21/24 between-arm P values are original significant results. The original statement that no prespecified clinically important minimum BCVA letter difference was identified is preserved. Statistical difference does not automatically establish clinical importance or daily-life benefit.",
      "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. A prespecified importance threshold, between-arm CI/exclusion of important effects and patient-related validation remain unverified. Existing content review remains incomplete.",
      "missingness": "A prespecified importance threshold, between-arm CI/exclusion of important effects and patient-related validation 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": "Prespecified threshold definition, between-arm intervals and patient-related evidence"
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is loss of more than 5 letters a minimum-important-benefit threshold?",
      "needed": "Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold 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 month-24 loss of >5 letters in 7%/18% from a benefit threshold 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 result adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, 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: Separate the loss threshold from importance of improvement. 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 safety/vision-loss wording records month-24 loss of more than 5 BCVA letters in 7% versus 18%. This is not converted into a prespecified minimum important improvement difference or responder/daily-function percentage.",
      "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. Loss definition, eye/person denominators, CI/prespecified hierarchy and relationship to an important-improvement threshold remain unverified. Existing content review remains incomplete.",
      "missingness": "Loss definition, eye/person denominators, CI/prespecified hierarchy and relationship to an important-improvement threshold 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-endpoint table, denominators, plans and threshold definition"
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How were bilateral eyes and repeated BCVA in the same participant analyzed?",
      "needed": "Within-person bilateral/repeated observations, centers and LS mean model definitions",
      "role": "Required",
      "role_reason": "This item distinguishes Within-person bilateral/repeated observations, centers and LS mean model definitions 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 Within-person bilateral/repeated observations, centers and LS mean model definitions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "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/person/time analysis structure. 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's month-13/21/24 data from 100 participants and 148 eyes may involve shared participants/eyes and repeated time points. Eyes/time points are not counted as new independent observations or trials; only original LS mean wording 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. Correlation/clustering, repeated-measures models, covariates, model assumptions and missing-data imputation remain unverified. Existing content review remains incomplete.",
      "missingness": "Correlation/clustering, repeated-measures models, covariates, model assumptions and missing-data imputation 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": "SAP, repeated/bilateral-eye models and denominator/covariate tables"
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is low-fluence sham the same as an unexposed comparator?",
      "needed": "Active low-fluence sham and the scope of the additional-effect comparison",
      "role": "Required",
      "role_reason": "This item distinguishes Active low-fluence sham and the scope of the additional-effect comparison 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 Active low-fluence sham and the scope of the additional-effect comparison 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 the active-comparator comparison definition. 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 sham was also an active comparator delivering low-fluence light. Results are not repurposed as effects versus no treatment, every other light therapy or an absolute standalone device effect.",
      "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. Exact sham fluence/exposure, masking, common treatments and comparator physiological effects remain unverified. Existing content review remains incomplete.",
      "missingness": "Exact sham fluence/exposure, masking, common treatments and comparator physiological effects 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": "Both arms' exposure/concomitant treatment, comparator definition and protocol"
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were masking, environment and learning effects in BCVA measurement verified?",
      "needed": "ETDRS best correction, repeated testing and assessor/condition standardization",
      "role": "Required",
      "role_reason": "This item distinguishes ETDRS best correction, repeated testing and assessor/condition standardization 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 ETDRS best correction, repeated testing and assessor/condition standardization must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; 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: Document measurement definitions and repeated-test conditions. 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 outcome is ETDRS best-corrected visual-acuity letters, and the double-masked design is preserved. Measurement conditions, learning and assessor influences in repeated chart testing are not arbitrarily established.",
      "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. Details of refractive correction, lighting, test distance, assessors/masking and repeated-test standardization remain unverified. Existing content review remains incomplete.",
      "missingness": "Details of refractive correction, lighting, test distance, assessors/masking and repeated-test standardization 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": "BCVA measurement instructions, masking and original test data"
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does eye-specific BCVA answer questions about daily visual function and independence?",
      "needed": "Distinguishing the surrogate, patient function, blindness and independence outcomes",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing the surrogate, patient function, blindness and independence 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 Distinguishing the surrogate, patient function, blindness and independence outcomes 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; 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: Provide separate materials for surrogate and direct functional 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": "The original manuscript describes chart letters as a surrogate for daily function. It is not extended to reading, driving, independence or blindness prevention; the related subclaim is graded ? and described as not primary and unestablished.",
      "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. Prespecified daily-function measures, denominators, between-arm values/CI and clinical-event outcomes remain unverified. Existing content review remains incomplete.",
      "missingness": "Prespecified daily-function measures, denominators, between-arm values/CI and clinical-event outcomes 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": "Patient-function/clinical-event outcomes and prespecified plans"
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what reporting level was exploratory vision-related quality of life examined?",
      "needed": "BCVA primary time points, exploratory quality of life and original-language scope",
      "role": "Required",
      "role_reason": "This item distinguishes BCVA primary time points, exploratory quality of life and original-language 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 BCVA primary time points, exploratory quality of life and original-language scope 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; own boundary for extrapolation",
      "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 functional outcomes to BCVA 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 the paper also explored vision-related quality of life, while BCVA was primary. Exploration is not promoted to confirmed functional benefit or a prespecified primary outcome.",
      "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. Measures, time points/hierarchy, values/CI/P, denominators and multiplicity remain unverified. Existing content review remains incomplete.",
      "missingness": "Measures, time points/hierarchy, values/CI/P, denominators and multiplicity 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 and prespecified plans"
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are month-24 results during repeated treatment persistent effects after treatment ends?",
      "needed": "Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up 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 repeated exposure every 4 months, observation period and unexposed follow-up 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; M19 §19.1.2–19.2.4; 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 persistence during/after exposure to period-specific 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 repeated-treatment conditions and month-24 BCVA reporting are preserved. These are not converted into persistence after treatment, lifetime vision/blindness prevention or efficacy under other repetition schedules.",
      "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 repeated exposure, follow-up after observation ends/without exposure and outcomes under other schedules remain unverified. Existing content review remains incomplete.",
      "missingness": "Actual repeated exposure, follow-up after observation ends/without exposure and outcomes under other schedules 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/unexposed data"
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the same report and related table kept separate from independent replication?",
      "needed": "LIGHTSITE III, shared patients/eyes/time points and the two questions",
      "role": "Required",
      "role_reason": "This item distinguishes LIGHTSITE III, shared patients/eyes/time points and the 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 LIGHTSITE III, shared patients/eyes/time points and the 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 relationships among shared trials/patients/eyes. 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": "LIGHTSITE III's 100 participants and 148 eyes from one existing report/bibliography are shared by the BCVA and daily-function tables. The same eyes/people, time points, outcomes and two tables 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 trial, participant and independent-replication totals have not been confirmed and remain unrecorded. Existing content review remains incomplete.",
      "missingness": "Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.",
      "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 relationships among reports/trials/populations and follow-up materials are supplied"
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were LumiThera and NEI support and the five authors' relationships?",
      "needed": "Separating funding, employment/consulting, individual roles and COI",
      "role": "Required",
      "role_reason": "This item distinguishes Separating funding, employment/consulting, individual 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 Separating funding, employment/consulting, individual 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: Document funding and each person's actual role. 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 support was LumiThera plus NEI1R43EY025508-03. S.E.Tedford, C.L.Croissant, M.R.Munk, R.Rückert and C.E.Tedford were the 5 authors described as employees or consultants. Employment versus consulting is not newly assigned to each person.",
      "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. Individual relationships, study/analysis/writing roles, contracts/COI and other support details remain unread externally. Existing content review remains incomplete.",
      "missingness": "Individual relationships, study/analysis/writing roles, contracts/COI and other support details remain unread externally.",
      "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": "Funding/contribution/author/COI and employment/consulting contract materials"
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were free device provision, analysis authority and manuscript involvement verified?",
      "needed": "Separate information on company funding, device provision, author roles and COI",
      "role": "Required",
      "role_reason": "This item distinguishes Separate information on company funding, device provision, author 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 Separate information on company funding, device provision, author 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 decision rights. 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 manufacturer support, 5 employee/consultant authors and parent I0/B2 are preserved as history. This wording alone does not establish free devices, all data rights or individual authors' COI.",
      "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. Free products/devices, data access/analysis/publication authority and individual COI remain unverified. Existing content review remains incomplete.",
      "missingness": "Free products/devices, data access/analysis/publication authority and individual COI 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 device-support, data/analysis/publication contracts and contributions/COI"
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is known about the registration identifier and actual prespecified plans?",
      "needed": "NCT04065490 identifier, month-13/21 plans and amendment history",
      "role": "Required",
      "role_reason": "This item distinguishes NCT04065490 identifier, month-13/21 plans and amendment history 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, month-13/21 plans and amendment history 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 time-point/outcome 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, linked to wording on prespecified month-13/21 BCVA time points. The identifier alone does not establish reading of registration/amendment history, protocol or 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. Original registration, plans, amendments/multiplicity and prespecification of a minimum important difference remain unread. Existing content review remains incomplete.",
      "missingness": "Original registration, plans, amendments/multiplicity and prespecification of a minimum important difference 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": "N24",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What denominators and periods apply to ocular AE and serious ocular AE?",
      "needed": "Events and person/eye units for 25.8/25.5% and 7.5/5.5%",
      "role": "Supplementary",
      "role_reason": "This item distinguishes Events and person/eye units for 25.8/25.5% and 7.5/5.5% 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 Events and person/eye units for 25.8/25.5% and 7.5/5.5% 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: Link event and denominator materials for each ocular harm. 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 rates of 25.8% versus 25.5% and serious ocular AE rates of 7.5% versus 5.5% are preserved. Eye, person or event counts, between-arm differences and risk ratios are not newly 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. Safety denominators, collection definitions, arms/time points, repeated events and missingness/CI remain unverified. Existing content review remains incomplete.",
      "missingness": "Safety denominators, collection definitions, arms/time points, repeated events and missingness/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, event definitions/collection and exposure/follow-up/denominators"
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Does no reported treatment-related serious-event or phototoxicity signal establish overall safety?",
      "needed": "Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms",
      "role": "Supplementary",
      "role_reason": "This item distinguishes Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms 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 Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms 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, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.",
      "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 reported signals from 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 manuscript states that treatment-related serious adverse events and phototoxicity signals were not reported. This is not converted into zero events, zero risk, long-term/other-device safety or a use recommendation.",
      "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. Collection/relatedness adjudication, follow-up losses, long-term/vulnerable-population harms and precision remain unverified. Existing content review remains incomplete.",
      "missingness": "Collection/relatedness adjudication, follow-up losses, long-term/vulnerable-population harms 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, original tables and long-term follow-up"
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can results be extended to other devices, diseases and acuity conditions?",
      "needed": "Valeda in dry AMD, the studied conditions and direct materials outside that scope",
      "role": "Required",
      "role_reason": "This item distinguishes Valeda in dry AMD, the studied conditions and direct 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 studied conditions and direct 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: Record condition-specific questions and direct-evidence 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 question is BCVA with original Valeda in dry AMD versus sham. It is not extended to other light devices, diseases/stages, daily function, blindness prevention or independence certification.",
      "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 comparisons/clinical outcomes and independent replication under other conditions remain unverified. Existing content review remains incomplete.",
      "missingness": "Direct comparisons/clinical outcomes and independent replication 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 direct materials for the relevant separate question are supplied"
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what level were the preserved summary and external papers/plans read?",
      "needed": "Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/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 Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI 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. Historical review statements or URLs do not upgrade current reading status.",
      "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, paper comparison and external-link/click checks were not performed in the recorded work. Existing content review remains incomplete.",
      "missingness": "External clinical-material access, paper comparison and external-link/click checks 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 original materials and actual reading records"
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are Korean/English texts, dates, original axes/empty values and corrections preserved?",
      "needed": "Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values",
      "role": "Required",
      "role_reason": "This item distinguishes Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values 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 Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values 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 production content. 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 original summary's Korean/English texts, parent C50/Caution, unrecorded/false precision indicators, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim C grade/note are distinguished from absent score/status/axes; the recorded work did not create a new English verdict translation, correction or reassessment.",
      "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, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.",
      "missingness": "At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections 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": "N29",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does condition freezing/application and table production establish completed content review?",
      "needed": "Separate condition preservation/freezing/application, case production and incomplete content review",
      "role": "Required",
      "role_reason": "This item distinguishes Separate condition preservation/freezing/application, case production and incomplete content 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 Separate condition preservation/freezing/application, case production and incomplete content 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, application, case production and content review are separate records. Existing content review remains incomplete; counts of rows, reports and materials are not unique clinical-trial or 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. The original authoring record did not perform self-review, tests, screen or link checks. Existing content review remains incomplete.",
      "missingness": "Existing content review remains incomplete. The original authoring record did not perform self-review, tests, screen or link checks.",
      "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 comments and additional 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": "Month 21: +6.2 (95% CI 4.2~8.2) versus +2.4 (−0.1~4.9), P=.0036; month 24: +5.6 versus +1.3, P=.0024. Each arm's CI differs from a between-arm-difference interval; the original counterview's approximate 3.8 letters is preserved only as an existing value. Month-24 >5-letter decline in 7%/18% is a separate loss endpoint. No new difference/CI, important difference, daily-life benefit or denominator is calculated.",
      "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": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}