{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral lactoferrin × day-60 tear-film tests after cataract surgery",
  "language": "en",
  "translation_date": "2026-10-16",
  "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What are the selected postoperative tear-film claim and original verdict?",
      "needed": "Day-60 tear-film tests after cataract surgery; existing subclaim verdict",
      "role": "Required",
      "role_reason": "This condition connects Day-60 tear-film tests after cataract surgery; existing subclaim verdict with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Day-60 tear-film tests after cataract surgery; existing subclaim verdict must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Detailed original material is needed on test definitions, surgical population, control, timing, denominators and question boundaries. Missing subclaim values are not filled from the parent. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Who were the patients without pre-existing dry eye?",
      "needed": "Small-incision cataract surgery population; exclusion of pre-existing dry eye",
      "role": "Required",
      "role_reason": "This condition connects Small-incision cataract surgery population; exclusion of pre-existing dry eye with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Small-incision cataract surgery population; exclusion of pre-existing dry eye must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Surgical and eligibility criteria, baseline tear-film measures and symptoms, excluded conditions and medicines, group baseline characteristics and actual eye/person denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What are the original day-60 tBUT values and units?",
      "needed": "Tear-breakup time; seconds; control",
      "role": "Required",
      "role_reason": "This condition connects Tear-breakup time; seconds; control with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Tear-breakup time; seconds; control must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Test procedures and assessors, group baseline/follow-up values and denominators, adjustment, original effects, CIs, exact P values and rules for averaging repeated measurements are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Is Schirmer test 1 distinguished from tBUT?",
      "needed": "Tear test 1; millimeters; test conditions",
      "role": "Required",
      "role_reason": "This condition connects Tear test 1; millimeters; test conditions with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Tear test 1; millimeters; test conditions must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual test methods, timing and conditions, baseline/follow-up tables, group denominators, effects, CIs, P values and tested-eye units are needed. No new instructions for performing the test are given. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Can the OSDI symptom proportion substitute for tear-film tests?",
      "needed": "Objective tests; proportion with at least mild OSDI symptoms",
      "role": "Required",
      "role_reason": "This condition connects Objective tests; proportion with at least mild OSDI symptoms with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Objective tests; proportion with at least mild OSDI symptoms must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: OSDI categories, measurement time, valid denominators, original continuous scores and proportions, effects, CIs and prespecified hierarchy are needed. Objective-test changes are not automatically combined into symptom or functional success. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Was lactoferrin added to routine postoperative care?",
      "needed": "Added oral lactoferrin; routine postoperative care",
      "role": "Required",
      "role_reason": "This condition connects Added oral lactoferrin; routine postoperative care with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Added oral lactoferrin; routine postoperative care must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Materials on identical drops and postoperative care in each group, actual treatment changes, adherence, exposure and control procedures are needed. No instructions for surgery, drops, care or treatment replacement are given. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What do 350 mg/day, the day after surgery and 60 days describe?",
      "needed": "Oral formulation; research exposure; duration",
      "role": "Required",
      "role_reason": "This condition connects Oral formulation; research exposure; duration with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Oral formulation; research exposure; duration must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original product quantities, formulation and composition, actual exposure and adherence, controls and intervention deviations are needed. Cumulative amounts and doses are not newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Do other vitamin or omega-3 combinations have the same evidence?",
      "needed": "Oral lactoferrin; boundaries between combinations and products",
      "role": "Required",
      "role_reason": "This condition connects Oral lactoferrin; boundaries between combinations and products with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Oral lactoferrin; boundaries between combinations and products must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Materials on the original lactoferrin product, active quantity, composition, source, manufacture and actual control are needed. No product recommendations, combination-product effects or dosing advice are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What are the 64 randomized patients, 58 completers and group denominators?",
      "needed": "32 allocated per group; 28 and 30 analyzed; 6 noncompleters",
      "role": "Required",
      "role_reason": "This condition connects 32 allocated per group; 28 and 30 analyzed; 6 noncompleters with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for 32 allocated per group; 28 and 30 analyzed; 6 noncompleters must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group allocation/completion/analysis flow, reasons and times of attrition, valid denominators for each test and OSDI, ITT and missing-data handling are needed. Detailed group tables were not compared this time. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are people, operated eyes, both eyes and repeated tests the same unit?",
      "needed": "Participant counts; tested eyes; analysis units",
      "role": "Required",
      "role_reason": "This condition connects Participant counts; tested eyes; analysis units with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Participant counts; tested eyes; analysis units must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Operated side, tested eyes, person-eye links, original monocular/binocular denominators, eye-selection rules and correlation/repeated-measure analyses are needed. Eye counts and participant totals are not newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are day-60 results distinguished from baseline, other times and persistence?",
      "needed": "Time-specific tests; natural recovery; persistence",
      "role": "Required",
      "role_reason": "This condition connects Time-specific tests; natural recovery; persistence with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Time-specific tests; natural recovery; persistence must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group baseline/intermediate/day-60/follow-up tables and denominators, between-group changes, CIs and concurrent surgical/drop care are needed. No new follow-up duration or effect is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "How were simple randomization, open-label design and no placebo recorded?",
      "needed": "Allocation; masked assessment; concurrent care",
      "role": "Required",
      "role_reason": "This condition connects Allocation; masked assessment; concurrent care with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Allocation; masked assessment; concurrent care must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Allocation methods and concealment, assessors and test procedures, matching routine care, missingness, selective reporting and original methods are needed. No new official RoB/GRADE rating or content-review approval is assigned. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are exact effects and CIs for the large test differences verified?",
      "needed": "Original group values; adjusted/change estimates; precision",
      "role": "Required",
      "role_reason": "This condition connects Original group values; adjusted/change estimates; precision with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Original group values; adjusted/change estimates; precision must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Test-specific original tables, between-group estimands, models, variance, CIs, P values, denominators and baseline adjustment are needed. No new effect sizes or hypothetical quantitative examples are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Is the prespecified hierarchy of both tests and OSDI verified?",
      "needed": "Primary/secondary endpoints; multiplicity; registration and plans",
      "role": "Required",
      "role_reason": "This condition connects Primary/secondary endpoints; multiplicity; registration and plans with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Primary/secondary endpoints; multiplicity; registration and plans must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Registration, protocols, SAPs, amendment histories, test/symptom hierarchy, times and analysis-population materials are needed. Unread material is not converted into failed prespecification or absence of research. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Can test improvement be extended to treatment of chronic dry eye in general?",
      "needed": "Selected postoperative population; symptoms; function; applicability",
      "role": "Required",
      "role_reason": "This condition connects Selected postoperative population; symptoms; function; applicability with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Selected postoperative population; symptoms; function; applicability must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct trials in each condition/population, patient-important symptoms and function, comparators, durations, effects and CIs are needed. No postoperative-care or dry-eye treatment instructions are given. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Is nonreporting of some symptoms the same as long-term safety?",
      "needed": "Diarrhea, appetite loss, rash and constipation; collection scope",
      "role": "Supplementary",
      "role_reason": "This condition connects Diarrhea, appetite loss, rash and constipation; collection scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Diarrhea, appetite loss, rash and constipation; collection scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Harms-collection definitions and active surveillance, exposure and denominators per group, discontinuation, attrition, other harms and long-term population data are needed. No new harm rates, zero-event examples or treatment advice are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Were the same trial, eyes and conditions kept out of independent-data totals?",
      "needed": "Shared parent, two subclaims, bibliography and participants",
      "role": "Required",
      "role_reason": "This condition connects Shared parent, two subclaims, bibliography and participants with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Shared parent, two subclaims, bibliography and participants must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Links among reports, cohorts, people, eyes, times, conditions and analysis populations are needed. Material counts are not quality scores or unique-trial counts. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What material was actually read during this production?",
      "needed": "Complete stored summary; external reading scope",
      "role": "Required",
      "role_reason": "This condition connects Complete stored summary; external reading scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Complete stored summary; external reading scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual original texts, supplements, registration, plans and reading records are needed. Historical full-text verification is not inherited as external reading in this work. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "How far are the original bibliography and registration identifiers linked?",
      "needed": "PMID, PMCID, DOI and registration information",
      "role": "Required",
      "role_reason": "This condition connects PMID, PMCID, DOI and registration information with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for PMID, PMCID, DOI and registration information must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact links among the paper, full text and registration, and materials on content and dates are needed. New full-text or registration URLs are not inferred from identifiers. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are historical verification statements in both languages distinguished from this review?",
      "needed": "Korean/English texts; existing claim; historical verification scope",
      "role": "Required",
      "role_reason": "This condition connects Korean/English texts; existing claim; historical verification scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Korean/English texts; existing claim; historical verification scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Content review of original texts, translation, corrections and question boundaries is needed. Historical statements are not labeled as completed content review or independent clinical validation in this work. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are subclaim values distinguished from parent C54, axes and safety?",
      "needed": "Subclaim grade/note; absent score, status and axes",
      "role": "Required",
      "role_reason": "This condition connects Subclaim grade/note; absent score, status and axes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Subclaim grade/note; absent score, status and axes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Content review of the selected record and original parent values is needed. No new efficacy grade, score, axes or regrading is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are the evidence date, correction history and production date distinguished?",
      "needed": "Evidence date; empty correction and deliberation records",
      "role": "Required",
      "role_reason": "This condition connects Evidence date; empty correction and deliberation records with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Evidence date; empty correction and deliberation records must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual follow-up/correction sources, complete prechange text and event histories are needed. Missing dates and correction values are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are funding, product support, employee authors and analysis roles distinguished?",
      "needed": "Four company-related aspects; historical independence statements",
      "role": "Required",
      "role_reason": "This condition connects Four company-related aspects; historical independence statements with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Four company-related aspects; historical independence statements must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original funding/COI declarations, product support, affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are allocation, measurement, missingness and selective-reporting details verified?",
      "needed": "Design; endpoint hierarchy; denominators",
      "role": "Required",
      "role_reason": "This condition connects Design; endpoint hierarchy; denominators with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Design; endpoint hierarchy; denominators must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Methods, protocols, SAPs, registration/amendment histories, original tables, effects of interest and denominators are needed. Design labels alone do not certify official RoB/GRADE ratings or review approval. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are actual exposure, concurrent care and repeated measurements verified?",
      "needed": "Research-intervention identity; adherence; co-interventions",
      "role": "Required",
      "role_reason": "This condition connects Research-intervention identity; adherence; co-interventions with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Research-intervention identity; adherence; co-interventions must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Product/formulation quantities, actual exposure, concurrent care, intervention deviations and denominators are needed. No new cumulative calculation, intake, product, eye-health or postoperative-care instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are the scope of harms reports and actual denominators distinguished?",
      "needed": "Existing safety description; collection/exposure denominators",
      "role": "Supplementary",
      "role_reason": "This condition connects Existing safety description; collection/exposure denominators with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Existing safety description; collection/exposure denominators must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Harms definitions, active collection, actual group exposure/denominators, discontinuation, attrition, severity and original control materials are needed. Existing “Good” safety is not transferred to all populations and durations. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What are the boundaries for long-term/rare harms and other populations?",
      "needed": "Original duration; illnesses; medicines; long-term scope",
      "role": "Supplementary",
      "role_reason": "This condition connects Original duration; illnesses; medicines; long-term scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Original duration; illnesses; medicines; long-term scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Long-term exposure/follow-up, harms surveillance, risk groups, medicines, group denominators, CIs and actual events are needed. No new treatment, intake, surgery or care instructions are given. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What material would trigger a sheet update?",
      "needed": "Distinguishing conditions, observations, original material and verdict changes",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing conditions, observations, original material and verdict changes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.",
      "criterion": "Material for Distinguishing conditions, observations, original material and verdict changes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Complete prechange text and records of condition versions, separate application and content review are needed. Added material, revised conditions and verdict changes remain separate events; no new research, calculations or regrading are executed. This records needed materials; no new research was executed."
    }
  ]
}