{ "schema_version": "chamgap-public-criteria-1.0", "title": "Valeda × Improved ETDRS best-corrected visual-acuity letters in dry AMD — Evidence check sheet", "language": "en", "translation_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }