{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral lactoferrin × gaps in direct evidence for chronic dry-eye treatment", "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": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "How is the general chronic-dry-eye question distinguished from the postoperative question?", "needed": "Selected chronic-dry-eye question, parent context and postoperative subclaim", "role": "Required", "role_reason": "This condition connects Selected chronic-dry-eye question, parent context and postoperative subclaim 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 chronic-dry-eye question, parent context and postoperative subclaim 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 and clinical independence of the general chronic-dry-eye question have not been newly verified. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What are the selected subclaim verdict and unrecorded values?", "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: Absent subclaim score, status and axes are not filled from parent values. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are general chronic-dry-eye patients the same as the actual surgical population?", "needed": "Chronic-dry-eye diagnosis, duration, severity and trial eligibility", "role": "Required", "role_reason": "This condition connects Chronic-dry-eye diagnosis, duration, severity and trial eligibility 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 Chronic-dry-eye diagnosis, duration, severity and trial eligibility 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 data by chronic-dry-eye diagnosis, duration, severity and subtype are unverified. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What is recorded about the original surgical population at baseline?", "needed": "Surgery type, baseline tear-film and symptom status, and eligibility", "role": "Supplementary", "role_reason": "This condition connects Surgery type, baseline tear-film and symptom status, and eligibility 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 Surgery type, baseline tear-film and symptom status, and eligibility 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: Baseline characteristics, exclusions, surgical method and test details are unverified. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which population do the oral formulation and exposure describe?", "needed": "Postoperative research exposure and the chronic-dry-eye exposure gap", "role": "Required", "role_reason": "This condition connects Postoperative research exposure and the chronic-dry-eye exposure gap 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 Postoperative research exposure and the chronic-dry-eye exposure gap 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: Manufacturing, source material, product specifications and direct exposure data in general chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are postoperative timing and chronic-dry-eye follow-up distinguished?", "needed": "Use for 60 days from the day after surgery versus long-term follow-up", "role": "Required", "role_reason": "This condition connects Use for 60 days from the day after surgery versus long-term follow-up 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 Use for 60 days from the day after surgery versus long-term follow-up 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 adherence, post-treatment follow-up and time-specific results in chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is the postoperative control the same as a chronic-dry-eye standard-care comparison?", "needed": "Routine postoperative care, add-on intervention and chronic-dry-eye comparators", "role": "Required", "role_reason": "This condition connects Routine postoperative care, add-on intervention and chronic-dry-eye comparators 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 Routine postoperative care, add-on intervention and chronic-dry-eye comparators 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: Details and adherence of postoperative drops, and direct comparisons with specific chronic-dry-eye standard treatments, are unverified. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are natural postoperative recovery and concurrent care distinguished?", "needed": "Natural recovery, shared drops and between-group differences", "role": "Required", "role_reason": "This condition connects Natural recovery, shared drops and between-group differences 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 Natural recovery, shared drops and between-group differences 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: Baseline and time-specific recovery, shared treatment types, changes and adherence are unverified. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which population does the day-60 tBUT value describe?", "needed": "Tear-breakup-time units, groups and timing", "role": "Supplementary", "role_reason": "This condition connects Tear-breakup-time units, groups and timing 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 units, groups and timing 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: Baseline values, repeated measurements, variance, effect CIs and endpoint-specific denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How is Schirmer testing distinguished from tBUT?", "needed": "Schirmer test 1, mm units, groups and timing", "role": "Supplementary", "role_reason": "This condition connects Schirmer test 1, mm units, groups and timing 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 Schirmer test 1, mm units, groups and timing 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 conduct, anesthesia, baseline and variability, CIs and denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What does the proportion with at least mild OSDI symptoms answer?", "needed": "Symptom scale, threshold, timing and original proportions", "role": "Supplementary", "role_reason": "This condition connects Symptom scale, threshold, timing and original proportions 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 Symptom scale, threshold, timing and original proportions 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: The mild-symptom score threshold, event counts, exact denominators, CIs and assessment procedure are unverified. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Has direct symptom improvement in general chronic dry eye been verified?", "needed": "Symptom scales and effects of interest in general chronic dry eye", "role": "Required", "role_reason": "This condition connects Symptom scales and effects of interest in general chronic 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 Symptom scales and effects of interest in general chronic 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: Direct symptom effects, CIs, denominators and duration in general chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Have quality-of-life and functional results in general chronic dry eye been verified?", "needed": "Disease-related quality of life, function and clinical importance", "role": "Required", "role_reason": "This condition connects Disease-related quality of life, function and clinical importance 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 Disease-related quality of life, function and clinical importance 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: Outcome definitions, effects of interest, importance and CIs in chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Do postoperative test differences answer general chronic-dry-eye treatment?", "needed": "Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes", "role": "Required", "role_reason": "This condition connects Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes 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 Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes 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 relationships among tests, symptoms and clinical outcomes in chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What has been verified about the original randomized parallel design?", "needed": "Center, simple randomization, allocation concealment and parallel comparison", "role": "Supplementary", "role_reason": "This condition connects Center, simple randomization, allocation concealment and parallel comparison 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 Center, simple randomization, allocation concealment and parallel comparison 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: Sequence generation, allocation concealment, baseline balance and allocation responsibility are unverified. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Have measurement procedures in the unmasked, no-placebo trial been verified?", "needed": "Participant and assessor masking, tests and symptom collection", "role": "Supplementary", "role_reason": "This condition connects Participant and assessor masking, tests and symptom collection 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 and assessor masking, tests and symptom collection 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: Assessor procedures, test standardization, OSDI collection and masking details are unverified. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What are the original randomized, completed and analyzed denominators?", "needed": "64 randomized, 58 analyzed, group allocation and noncompletion", "role": "Supplementary", "role_reason": "This condition connects 64 randomized, 58 analyzed, group allocation and noncompletion 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 64 randomized, 58 analyzed, group allocation and noncompletion 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: Endpoint-specific valid denominators, missingness, group-specific dropout reasons and detailed original tables are unverified. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Have people, eyes and repeated measurements been distinguished?", "needed": "Participants, one or both eyes, and visit-specific observations", "role": "Required", "role_reason": "This condition connects Participants, one or both eyes, and visit-specific observations 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 Participants, one or both eyes, and visit-specific observations 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/tested-eye selection, correlation between eyes, repeated-measure handling and denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Have completer analysis and missing-data handling been verified?", "needed": "Effects of interest in completers versus randomized participants and missing data", "role": "Required", "role_reason": "This condition connects Effects of interest in completers versus randomized participants and missing data 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 Effects of interest in completers versus randomized participants and missing data 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: Analysis-population definitions, reasons for and handling of missing data, sensitivity analyses and adjusted models are unverified. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are final values distinguished from baseline changes and adjusted effects?", "needed": "Day-60 final values, baseline values and effects of interest", "role": "Required", "role_reason": "This condition connects Day-60 final values, baseline values and effects of interest 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 final values, baseline values and effects of interest 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: Baseline, changes, variance, adjusted effects and CIs are unverified. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Have precision and clinical importance of the original results been verified?", "needed": "Variance, P values, CIs and importance of test and symptom results", "role": "Required", "role_reason": "This condition connects Variance, P values, CIs and importance of test and symptom results 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 Variance, P values, CIs and importance of test and symptom results 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: CIs, variance, denominators and clinical importance for test and OSDI effects are unverified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Has the prespecified hierarchy of test and symptom outcomes been verified?", "needed": "Primary, secondary and coprimary outcomes, visits and multiplicity", "role": "Required", "role_reason": "This condition connects Primary, secondary and coprimary outcomes, visits and multiplicity 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 and coprimary outcomes, visits and multiplicity 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: Prespecified outcome hierarchy, visit analyses, multiplicity and selective-reporting plans are unverified. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Have registration, protocol and analysis plans actually been read?", "needed": "Registration identifiers, prior plans and current reading scope", "role": "Required", "role_reason": "This condition connects Registration identifiers, prior plans and current 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 Registration identifiers, prior plans and current 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 registration existence, identifiers and plan contents are unverified. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is the scope of the original funding and competing-interest statement?", "needed": "Original disclosures, funding, product provision and support roles", "role": "Supplementary", "role_reason": "This condition connects Original disclosures, funding, product provision and support roles 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 disclosures, funding, product provision and support roles 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 disclosures, funding sources, product provision, employment, and design, analysis and publication roles remain unverified in detail. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How are the same report, trial, people and tests distinguished?", "needed": "Devendra and Singh bibliography, study family and observation relationships", "role": "Required", "role_reason": "This condition connects Devendra and Singh bibliography, study family and observation relationships 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 Devendra and Singh bibliography, study family and observation relationships 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: Related reports, populations and unique-trial/participant totals have not been newly established. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Has direct independent replication in general chronic dry eye been verified?", "needed": "Direct reports, trial relationships and independence in the selected population", "role": "Required", "role_reason": "This condition connects Direct reports, trial relationships and independence in the selected population 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 Direct reports, trial relationships and independence in the selected population 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: Identities and overlap of direct replication or independent reports in general chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Can results be transferred to combinations, other formulations or subtypes?", "needed": "Boundaries between single lactoferrin and other products or populations", "role": "Supplementary", "role_reason": "This condition connects Boundaries between single lactoferrin and other products or populations 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 Boundaries between single lactoferrin and other products or populations 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 comparisons for combinations, other formulations and subtypes are unverified. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are persistence and post-treatment follow-up in general chronic dry eye available?", "needed": "Time-specific symptoms, tests and post-discontinuation outcomes", "role": "Required", "role_reason": "This condition connects Time-specific symptoms, tests and post-discontinuation outcomes 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 symptoms, tests and post-discontinuation outcomes 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: Persistence, recurrence, long-term effects, CIs and denominators in general chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are acquisition, actual reading and source links distinguished?", "needed": "Stored summary versus external abstracts, full text and needed material", "role": "Required", "role_reason": "This condition connects Stored summary versus external abstracts, full text and needed material 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 Stored summary versus external abstracts, full text and needed material 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: Current content verification of the external paper's methods and result tables remains incomplete. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are original Korean/English values, dates and historical checks distinguished?", "needed": "Original bilingual text, evidence date, corrections, axes and empty values", "role": "Required", "role_reason": "This condition connects Original bilingual text, evidence date, corrections, axes and empty values 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 bilingual text, evidence date, corrections, axes and empty values 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 translation and correction comparison against external originals were not performed this time. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Have adverse-event collection and definitions been verified?", "needed": "Symptom collection, severity and active/passive assessment", "role": "Supplementary", "role_reason": "This condition connects Symptom collection, severity and active/passive assessment 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 Symptom collection, severity and active/passive assessment 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: Collection methods, definitions, severity and other harm outcomes are unverified. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What denominators and comparisons underlie no reports of four symptoms?", "needed": "58 analyzed, group-specific harm denominators and reporting scope", "role": "Supplementary", "role_reason": "This condition connects 58 analyzed, group-specific harm denominators and reporting 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 58 analyzed, group-specific harm denominators and reporting 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: Group-specific/all-randomized harm denominators, collection completeness and CIs are unverified. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Have harm timing and long-term or delayed observation been verified?", "needed": "Exposure/follow-up timing and symptom observation periods", "role": "Supplementary", "role_reason": "This condition connects Exposure/follow-up timing and symptom observation periods 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 Exposure/follow-up timing and symptom observation periods 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: Symptom onset/end and delayed or long-term harm follow-up are unverified. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Have alternative causes involving surgery, drops and baseline status been distinguished?", "needed": "Natural postoperative course, concurrent care and harm relationships", "role": "Supplementary", "role_reason": "This condition connects Natural postoperative course, concurrent care and harm relationships 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 Natural postoperative course, concurrent care and harm relationships 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: Event-specific timing, concurrent medicines, baseline status and relatedness assessment are unverified. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Have effects of noncompletion on harms and efficacy been verified?", "needed": "Reasons for 6 noncompleters, group missingness and data handling", "role": "Supplementary", "role_reason": "This condition connects Reasons for 6 noncompleters, group missingness and data handling 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 Reasons for 6 noncompleters, group missingness and data handling 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-specific dropout reasons, discontinuation, missingness and event handling are unverified. This records needed materials; no new research was executed." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Have separate harm data in general chronic dry eye been verified?", "needed": "Direct safety in the selected chronic-dry-eye population and formulation", "role": "Supplementary", "role_reason": "This condition connects Direct safety in the selected chronic-dry-eye population and formulation 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 Direct safety in the selected chronic-dry-eye population and formulation 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: Identities of separate harm studies and reports in general chronic dry eye are unverified. This records needed materials; no new research was executed." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "What is the scope for allergy, comorbidities, medicines and long-term use?", "needed": "Originally limited populations and actual collection/follow-up", "role": "Supplementary", "role_reason": "This condition connects Originally limited populations and actual collection/follow-up 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 Originally limited populations and actual collection/follow-up 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: Eligibility, exposure, medicines, long-term events and denominators in those populations are unverified. This records needed materials; no new research was executed." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Is no reporting of selected symptoms distinguished from overall safety?", "needed": "Selected symptoms, parent safety history and selected-population safety", "role": "Supplementary", "role_reason": "This condition connects Selected symptoms, parent safety history and selected-population safety 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 symptoms, parent safety history and selected-population safety 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 comparative harms, causality, precision and long-term event data are unverified. This records needed materials; no new research was executed." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How will later evidence and condition versions be linked?", "needed": "New original material, before/after values, actual reading and condition changes", "role": "Supplementary", "role_reason": "This condition connects New original material, before/after values, actual reading and condition 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 New original material, before/after values, actual reading and condition 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: No later original material or actual reading/change event is currently recorded. This records needed materials; no new research was executed." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are earlier production and current content verification distinguished?", "needed": "Original selection history, production, content and boundary review", "role": "Supplementary", "role_reason": "This condition connects Original selection history, production, content and boundary review 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 selection history, production, content and boundary review 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: Later content-review decisions and the final count of clinical independence remain undecided. This records needed materials; no new research was executed." } ] }