{ "schema_version": "chamgap-public-criteria-1.0", "title": "Olistic Women finished product · Six-month TrichoScan hair density — Evidence Check", "language": "en", "translation_date": "2026-10-12", "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 methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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 methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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 methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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 methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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 methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" } ], "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": "Comparative efficacy: finished product and selected endpoint", "question": "What are the selected finished-product question and original subclaim assessment?", "needed": "Original six-month TrichoScan hair-density text, grade and note", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Original six-month TrichoScan hair-density text, grade and note; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish the original assessment from production and review of existing content" }, { "item_id": "N02", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the actual population and scope of telogen-effluvium diagnosis?", "needed": "Premenopausal women, diagnosis, eligibility, baseline and exclusions", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Premenopausal women, diagnosis, eligibility, baseline and exclusions; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish the recruited population from other hair-loss conditions and populations" }, { "item_id": "N03", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the actual finished product and study exposure?", "needed": "Olistic Women finished product, formulation, study exposure and duration", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Olistic Women finished product, formulation, study exposure and duration; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish finished-product identity from actual exposure and guidance" }, { "item_id": "N04", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are placebo composition, appearance and blinding verified?", "needed": "Product/placebo composition, matching and blinding implementation", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Product/placebo composition, matching and blinding implementation; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish the design name from actual blinding implementation" }, { "item_id": "N05", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are allocation, analysis, completion and missing-data denominators separated?", "needed": "106 allocated, 53/53, measurements/analysis/exclusions by timepoint", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "106 allocated, 53/53, measurements/analysis/exclusions by timepoint; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Separate allocation from actually observed and analyzed denominators" }, { "item_id": "N06", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What is the original record scope for random-sequence generation and allocation concealment?", "needed": "Sequence, concealment, baseline, actual implementation and original descriptions", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Sequence, concealment, baseline, actual implementation and original descriptions; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish historically unverified methods from current summary reading" }, { "item_id": "N07", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are missing-data handling, analysis populations and effects of interest known?", "needed": "Group exclusions, missingness, ITT/PP, models and adjustment", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Group exclusions, missingness, ITT/PP, models and adjustment; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Separate allocation, actual use, completers and missing-data assumptions" }, { "item_id": "N08", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Can concurrent treatment, changes in hair-loss causes and product adherence be distinguished?", "needed": "Concurrent treatment, nutrition, other products, causes, changes and adherence", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Concurrent treatment, nutrition, other products, causes, changes and adherence; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish finished-product effects from other possible changes" }, { "item_id": "N09", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the primary endpoint’s measurement, unit and definition?", "needed": "TrichoScan phototrichoscopy, change from baseline in density and hairs/cm²", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "TrichoScan phototrichoscopy, change from baseline in density and hairs/cm²; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish device-measured density from patient-centered outcomes" }, { "item_id": "N10", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Do day-180 changes by group differ from final density?", "needed": "Baseline, change and final values for each group and definition of ±", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Baseline, change and final values for each group and definition of ±; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish changes, absolute values, dispersion and precision" }, { "item_id": "N11", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the test and confidence interval for the selected between-group comparison?", "needed": "Day-180 comparison, effect scale, P value and CI", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Day-180 comparison, effect scale, P value and CI; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Display directly reported tests together with gaps in effects/CIs" }, { "item_id": "N12", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Does an important clinical difference explain the device measurement?", "needed": "Prespecified hairs/cm² importance, direct perception and clinical criteria", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Prespecified hairs/cm² importance, direct perception and clinical criteria; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Separate statistical values from clinical importance" }, { "item_id": "N13", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Was the day-90 result counted as independent replication or merged with day 180?", "needed": "Values, denominators, plans and measurements by timepoint", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Values, denominators, plans and measurements by timepoint; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish direct timepoint data from shared participants and measurements" }, { "item_id": "N14", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Was the secondary hair-cycle ratio merged with density?", "needed": "Anagen-to-catagen/telogen ratio, hierarchy and definition", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Anagen-to-catagen/telogen ratio, hierarchy and definition; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish density, hair-cycle ratios and analysis hierarchy" }, { "item_id": "N15", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are first registration posting and primary-completion dates distinguished?", "needed": "NCT07111312, first posting, completion, original plans and history", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "NCT07111312, first posting, completion, original plans and history; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Display completion, registration and paper events separately" }, { "item_id": "N16", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Do original primary/secondary descriptions differ from independently prespecified plans?", "needed": "Endpoint hierarchy, protocol/SAP, multiplicity and change documents", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Endpoint hierarchy, protocol/SAP, multiplicity and change documents; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish paper hierarchy descriptions from the verified scope of independent prospective plans" }, { "item_id": "N17", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Does TrichoScan density mean visibly fuller hair?", "needed": "Direct appearance, satisfaction, perception and function endpoints", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Direct appearance, satisfaction, perception and function endpoints; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish device measurements from gaps in the separate appearance question" }, { "item_id": "N18", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Was a finished-product effect extended to ingredients or other hair supplements?", "needed": "Direct comparisons for this product, other formulations and individual ingredients", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Direct comparisons for this product, other formulations and individual ingredients; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Preserve applicability boundaries between this product and other product/ingredient questions" }, { "item_id": "N19", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Does six-month efficacy mean persistence after completion or prevention of all hair loss?", "needed": "Postcompletion follow-up, long-term density and clinical outcomes", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Postcompletion follow-up, long-term density and clinical outcomes; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish exposure-period results from direct postcompletion results" }, { "item_id": "N20", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are the same trial, citation, registration and two subclaims independent replication?", "needed": "CT-OW-02, paper, registration, shared participants and timepoint linkage", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "CT-OW-02, paper, registration, shared participants and timepoint linkage; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish endpoint/report slots from trial/participant units" }, { "item_id": "N21", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Is there independent replication beyond one small manufacturer trial?", "needed": "Actual independent replication of the same finished product, population and duration", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Actual independent replication of the same finished product, population and duration; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish original sample-size limits from gaps in independent replication" }, { "item_id": "N22", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are research funding, publication fees and product/placebo support separated?", "needed": "Company funding, publication fees and product/placebo supply disclosures", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Company funding, publication fees and product/placebo supply disclosures; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Display research costs, publication fees and product support separately" }, { "item_id": "N23", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are sponsor, responsible party and company-employed author distinguished?", "needed": "Responsibility, registrant, author relationships/contributions and data rights", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Responsibility, registrant, author relationships/contributions and data rights; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish support, responsibility, employees and individual roles" }, { "item_id": "N24", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Were all outsourced analysis, medical writing and editing roles verified?", "needed": "Actual disclosures of analysis, writing, editing and other support", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Actual disclosures of analysis, writing, editing and other support; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Record reported involvement separately from unverified roles" }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Are noncollection and nonreporting of minor adverse events distinguished?", "needed": "Harm collection/classification, group observations and exposure denominators", "role": "Supplementary", "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Harm collection/classification, group observations and exposure denominators; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish noncollection from observed zero events and nonreporting" }, { "item_id": "N26", "question_type": "Supplementary harm evidence", "question": "Are serious-harm, discontinuation and relatedness material available?", "needed": "Serious events, discontinuation/reasons, relatedness, control and denominators", "role": "Supplementary", "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Serious events, discontinuation/reasons, relatedness, control and denominators; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Display collection limits separately from gaps in other harm material" }, { "item_id": "N27", "question_type": "Supplementary harm evidence", "question": "Can long-term/rare harms or tolerability in other populations be judged?", "needed": "Long exposure, rare events, vulnerable populations and follow-up", "role": "Supplementary", "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Long exposure, rare events, vulnerable populations and follow-up; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Distinguish short-term efficacy values from gaps in long-term safety" }, { "item_id": "N28", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are the actually read summary and external abstract/full text/registration/plans shown?", "needed": "Preserved summary, citation URL and actual reading status by material", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Preserved summary, citation URL and actual reading status by material; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Display summary reading and unread external material separately" }, { "item_id": "N29", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are original history, parent values and linkage separated from production and review of existing content?", "needed": "Korean/English text, axes, dates, corrections, existing selection and freeze/application", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Korean/English text, axes, dates, corrections, existing selection and freeze/application; preserve original values, direct observations, scope and gaps without creating new effects, assessments, calculations or independent certification", "basis": "Retain the production copy of existing methodology application records and methodology linkage; full definition review and official certification are incomplete", "condition_origin": "New production condition; existing-content review and automatic verification-process passage are incomplete", "proposed_research": "Record original assessment/corrections separately from production and review of existing content" } ] }