{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2956-s1",
  "verdict_number": "2956",
  "title": "Olistic Women · Direct-evidence gaps for visibly fuller hair",
  "view_version": "1.0",
  "view_created_date": "2026-10-12",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "106 premenopausal women diagnosed with telogen effluvium, allocated 53/53. Detailed diagnosis/baseline and appearance-response/analysis populations are unverified.",
    "intervention": "Olistic Women drinkable multi-ingredient nutraceutical",
    "dose": "Original trial exposure: one 25-mL finished-product vial daily for six months. Actual adherence, ingredient quantities and other exposures are unverified; this is not use guidance.",
    "comparator": "Manufacturer-supplied placebo. Original composition/appearance, actual common management/concurrent exposure and assessor blinding details are unverified.",
    "endpoint": "The selection concerns visibly fuller hair. Retain original grade ? and the note that appearance was not primary. Direct appearance/patient-perception definitions, scales, photographs/assessment, denominators, effects and intervals are unverified.",
    "duration": "Original six-month instrumental trial and day-90/day-180 results context. Actual appearance-assessment timing and post-discontinuation/long-term durability are unverified.",
    "excluded_extensions": [
      "Transferring TrichoScan density, cycle-ratio and day-90/day-180 signals into visible appearance/patient-perception effects",
      "Subtracting product/placebo changes to create a new net effect, treating ± as a CI or converting density into appearance scores/response rates",
      "Copying/summing 106/53 allocation or measurement areas/time points as valid appearance denominators or total participants",
      "Promoting retrospective-registration results to prospective registration or current plan certification",
      "Changing minor-AE noncollection into all harms zero or good tolerability/long-term safety",
      "Generalizing to other products/ingredients, hair-loss types/populations or long-term/post-discontinuation effects",
      "Instructions for product consumption, hair/cosmetic care or hair-loss/nutrition treatment/substitution"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the selected original question and assessment record?",
      "needed": "Original visibly fuller hair wording, Korean/English texts and link",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Original visibly fuller hair wording, Korean/English texts and link.",
      "application_exception": "Do not count instrumental and appearance questions in one report as new independent trials or participants.",
      "criterion": "Link Original visibly fuller hair wording, Korean/English texts and link to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If the question changes, retain original wording, the previous complete version and the change event.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The selected original question and assessment record concern visibly fuller hair. Parent and sibling TrichoScan hair-density questions concern a different endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. No new independent-claim certification, structural split or invented main assessment was created.",
      "missingness": "No new independent-claim certification, structural split or invented main assessment was created.",
      "uncertainty": "Within the production scope of the preserved summary. No new independent-claim certification, structural split or invented main assessment was created.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Preserved selected assessment record and complete parent summary"
    },
    {
      "item_id": "N02",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "How do the subclaim ? and parent C50, axes and history differ?",
      "needed": "Subclaim grade/note, absent score/status/axes and actual parent values",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Subclaim grade/note, absent score/status/axes and actual parent values.",
      "application_exception": "Do not transfer parent measured-density C50 or historical cross-checks into a new appearance assessment, score or completed content review.",
      "criterion": "Link Subclaim grade/note, absent score/status/axes and actual parent values to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish actual evidence-update events from preservation of original values.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The subclaim is ? with the note that the primary endpoint was not appearance. Score/status/axes keys are absent. Parent C50, Unknown and B/S/R1/I0/E+/B1 with precision null are parent context.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Selected-row score, status and axes are null; do not fill them with parent score or grade.",
      "missingness": "Selected-row score, status and axes are null; do not fill them with parent score or grade.",
      "uncertainty": "Within the production scope of the preserved summary. Selected-row score, status and axes are null; do not fill them with parent score or grade.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original subclaim record and parent grade/score/axes and assessment history"
    },
    {
      "item_id": "N03",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "Which selected population of women entered the finished-product trial?",
      "needed": "Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection.",
      "application_exception": "Do not generalize to all female hair loss, men, postmenopausal women, other hair-loss types or deficiency populations.",
      "criterion": "Link Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish other-population material by actual diagnosis, menopausal status, baseline characteristics and selection.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CT-OW-02 was a multicenter trial in 106 premenopausal women diagnosed with telogen effluvium.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Age, diagnostic criteria, acute/chronic course, baseline hair loss, nutritional status, recruitment/exclusion and representativeness details are unverified.",
      "missingness": "Age, diagnostic criteria, acute/chronic course, baseline hair loss, nutritional status, recruitment/exclusion and representativeness details are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Age, diagnostic criteria, acute/chronic course, baseline hair loss, nutritional status, recruitment/exclusion and representativeness details are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original diagnostic/selection criteria, baseline characteristics and recruitment flow"
    },
    {
      "item_id": "N04",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What material describes baseline appearance, hair loss and diagnosis?",
      "needed": "Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment.",
      "application_exception": "Do not create clinical hair-loss severity, baseline perception or differential diagnoses from TrichoScan numbers alone.",
      "criterion": "Link Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Record actual baseline diagnosis and starting appearance when appearance-change material becomes available.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original summary records telogen-effluvium diagnosis and TrichoScan results without providing direct selected appearance-assessment material.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Diagnostic methods, differential assessment, baseline photographs/appearance, patient burden, duration and mixed diagnoses are unverified.",
      "missingness": "Diagnostic methods, differential assessment, baseline photographs/appearance, patient burden, duration and mixed diagnoses are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Diagnostic methods, differential assessment, baseline photographs/appearance, patient burden, duration and mixed diagnoses are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original diagnosis, baseline appearance/symptoms and assessment criteria"
    },
    {
      "item_id": "N05",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the finished product and ingredient scope?",
      "needed": "Olistic Women drinkable multi-ingredient finished product, formulation and composition",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Olistic Women drinkable multi-ingredient finished product, formulation and composition.",
      "application_exception": "Do not fill in unrecorded biotin/vitamins/botanicals or attribute an effect to an individual ingredient.",
      "criterion": "Link Olistic Women drinkable multi-ingredient finished product, formulation and composition to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If material is provided, distinguish the finished product from individual ingredients and other formulations.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original product is Olistic Women drinkable multi-ingredient nutraceutical. The manufacturer is recorded as supplying trial product and placebo.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Ingredient identities/quantities, batch, standardization, packaging/form and individual-ingredient effects are unverified.",
      "missingness": "Ingredient identities/quantities, batch, standardization, packaging/form and individual-ingredient effects are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Ingredient identities/quantities, batch, standardization, packaging/form and individual-ingredient effects are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial finished-product composition, batch, formulation and supply records"
    },
    {
      "item_id": "N06",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were the original trial exposure and actual implementation?",
      "needed": "One 25-mL vial daily for six months and actual adherence/exposure",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of One 25-mL vial daily for six months and actual adherence/exposure.",
      "application_exception": "Do not write consumption, product-selection, dosing, dose-conversion or treatment instructions.",
      "criterion": "Link One 25-mL vial daily for six months and actual adherence/exposure to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish nominal exposure from actual implementation in subsequent material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original product information describes a finished-product trial of one 25-mL vial daily for six months. This preserves trial exposure.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Actual adherence, cumulative exposure, stopping/changes, ingredients per vial and other-dose comparisons are unverified.",
      "missingness": "Actual adherence, cumulative exposure, stopping/changes, ingredients per vial and other-dose comparisons are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Actual adherence, cumulative exposure, stopping/changes, ingredients per vial and other-dose comparisons are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual product exposure, adherence and discontinuation records"
    },
    {
      "item_id": "N07",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were the placebo and common conditions?",
      "needed": "Manufacturer-supplied placebo, actual composition/appearance and comparison direction",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Manufacturer-supplied placebo, actual composition/appearance and comparison direction.",
      "application_exception": "Do not change placebo into no treatment or an unrecorded active comparator.",
      "criterion": "Link Manufacturer-supplied placebo, actual composition/appearance and comparison direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish the actual product/placebo contrast from comparisons with other ingredients.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CT-OW-02 was placebo-controlled; the company is recorded as supplying product and placebo.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Placebo ingredients/calories, appearance/taste matching, distribution/adherence and differences in common management are unverified.",
      "missingness": "Placebo ingredients/calories, appearance/taste matching, distribution/adherence and differences in common management are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Placebo ingredients/calories, appearance/taste matching, distribution/adherence and differences in common management are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Placebo composition, common conditions and actual exposure/blinding material"
    },
    {
      "item_id": "N08",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were randomization and actual analysis scopes?",
      "needed": "106 participants, 53/53 allocation, sequence/concealment and completion/analysis",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of 106 participants, 53/53 allocation, sequence/concealment and completion/analysis.",
      "application_exception": "Do not copy 53/53 as verified analysis denominators for every time point/appearance endpoint or assign new methodological-defect scores.",
      "criterion": "Link 106 participants, 53/53 allocation, sequence/concealment and completion/analysis to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If original material is provided, distinguish allocation from actual completion/analysis and measurement level.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original trial randomized 106 participants, 53/53. Historical wording also says random-sequence and allocation-concealment methods were not confirmed in the public paper.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Actual completion and appearance/instrumental analysis denominators, original sequence/concealment methods and flow remain unread.",
      "missingness": "Actual completion and appearance/instrumental analysis denominators, original sequence/concealment methods and flow remain unread.",
      "uncertainty": "Within the production scope of the preserved summary. Actual completion and appearance/instrumental analysis denominators, original sequence/concealment methods and flow remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation methods, group flow and actual endpoint-specific analysis n"
    },
    {
      "item_id": "N09",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were double-blinding and appearance-assessor conditions?",
      "needed": "Participants/measurers, photograph/appearance reading and maintained blinding",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Participants/measurers, photograph/appearance reading and maintained blinding.",
      "application_exception": "Do not confirm separate appearance assessment or blinding of every assessor from the design label alone.",
      "criterion": "Link Participants/measurers, photograph/appearance reading and maintained blinding to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Record patient/independent-assessor blinding and consistent assessment conditions in appearance material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original design was a multicenter double-blind placebo-controlled randomized trial.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Who was blinded, product distinguishability, instrumental/appearance/photograph assessors and unblinding timing are unverified.",
      "missingness": "Who was blinded, product distinguishability, instrumental/appearance/photograph assessors and unblinding timing are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Who was blinded, product distinguishability, instrumental/appearance/photograph assessors and unblinding timing are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Blinding, reading, photograph/appearance methods and actual implementation"
    },
    {
      "item_id": "N10",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were concurrent hair care, treatment and natural course?",
      "needed": "Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery.",
      "application_exception": "Do not write new treatment, washing/cosmetic or hair-care methods or calculate natural recovery.",
      "criterion": "Link Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish finished-product exposure from concurrent management/natural course in later appearance material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary records instrumental results for a particular finished product and placebo.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Concurrent treatment/nutrition/hair care, cosmetic/styling changes, lifestyle, natural course and group differences are unverified.",
      "missingness": "Concurrent treatment/nutrition/hair care, cosmetic/styling changes, lifestyle, natural course and group differences are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Concurrent treatment/nutrition/hair care, cosmetic/styling changes, lifestyle, natural course and group differences are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original common/restricted conditions, concurrent exposure and actual implementation"
    },
    {
      "item_id": "N11",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What is the direct endpoint for visibly fuller hair?",
      "needed": "Visible fullness definition, observer and patient perception",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Visible fullness definition, observer and patient perception.",
      "application_exception": "Do not present density change or the question wording as observed appearance improvement.",
      "criterion": "Link Visible fullness definition, observer and patient perception to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Report actual appearance assessor, definition, timing and denominator separately from instrumental counts.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original subclaim note says appearance was not the primary endpoint. The parent distinguishes TrichoScan counts from patient perception.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Appearance definition, observer/patient judgment, actual assessment and scale/categories are unverified.",
      "missingness": "Appearance definition, observer/patient judgment, actual assessment and scale/categories are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Appearance definition, observer/patient judgment, actual assessment and scale/categories are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct appearance/patient-perception definitions, results and methods"
    },
    {
      "item_id": "N12",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the appearance scale and units of visible change?",
      "needed": "Visible change, scale, photograph/assessment and direction",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Visible change, scale, photograph/assessment and direction.",
      "application_exception": "Do not convert hairs/cm² into appearance scores, fullness percentages or perceived change.",
      "criterion": "Link Visible change, scale, photograph/assessment and direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "State scale direction, observer and change definition in appearance material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary provides no direct appearance-change score, unit or response category.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Photographic assessment/scale, overall appearance, observer agreement, assessment conditions and validity criteria are unverified.",
      "missingness": "Photographic assessment/scale, overall appearance, observer agreement, assessment conditions and validity criteria are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Photographic assessment/scale, overall appearance, observer agreement, assessment conditions and validity criteria are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct appearance scale, definitions, measurement/reading methods and results"
    },
    {
      "item_id": "N13",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "Is actual standardized-photograph or independent-assessment material available?",
      "needed": "Photographs/independent observation, consistent conditions, blinding and judgment",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Photographs/independent observation, consistent conditions, blinding and judgment.",
      "application_exception": "Do not assert that photographic assessment existed or did not exist, or provide photography/hair-care procedures.",
      "criterion": "Link Photographs/independent observation, consistent conditions, blinding and judgment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "State assessment conditions, independence and judgment level in later appearance material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original summary only provides the boundary that appearance assessment was not the primary endpoint.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Whether photographs were taken/read, lighting/angle/styling conditions, independent assessment, blinding, agreement and results are unverified.",
      "missingness": "Whether photographs were taken/read, lighting/angle/styling conditions, independent assessment, blinding, agreement and results are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Whether photographs were taken/read, lighting/angle/styling conditions, independent assessment, blinding, agreement and results are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original methods and actual direct photograph-assessment results"
    },
    {
      "item_id": "N14",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the direct patient-perception, satisfaction and quality-of-life values?",
      "needed": "Distinguish patient perception, appearance/satisfaction and symptoms/quality of life",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Distinguish patient perception, appearance/satisfaction and symptoms/quality of life.",
      "application_exception": "Do not attribute positive density numbers to improved satisfaction or quality of life.",
      "criterion": "Link Distinguish patient perception, appearance/satisfaction and symptoms/quality of life to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Record instrumental counts, appearance observation, satisfaction and quality of life as separate endpoints.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original reader answer distinguishes perceived visible fullness from instrumental counts.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Patient-reported fullness, satisfaction, burden/quality of life, response scales, denominators and effects are unverified.",
      "missingness": "Patient-reported fullness, satisfaction, burden/quality of life, response scales, denominators and effects are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Patient-reported fullness, satisfaction, burden/quality of life, response scales, denominators and effects are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Patient-centered outcomes, scales, response/analysis n and original results tables"
    },
    {
      "item_id": "N15",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are appearance-assessment timing and durability?",
      "needed": "Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up.",
      "application_exception": "Do not use day-90/day-180 instrumental signals to fill appearance improvement, long-term maintenance or recurrence prevention.",
      "criterion": "Link Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish on-treatment measurement from post-discontinuation persistence by actual timing and denominator.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original trial describes six months and day-90/day-180 instrumental results. Actual selected appearance measurement/follow-up is not separately provided.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Appearance-assessment timing, persistence, follow-up after stopping and long-term patient perception are unverified.",
      "missingness": "Appearance-assessment timing, persistence, follow-up after stopping and long-term patient perception are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Appearance-assessment timing, persistence, follow-up after stopping and long-term patient perception are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct appearance assessment by time point and post-discontinuation follow-up"
    },
    {
      "item_id": "N16",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What separate measurement is the TrichoScan endpoint?",
      "needed": "Phototrichoscopy, change from baseline density and hairs/cm²",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Phototrichoscopy, change from baseline density and hairs/cm².",
      "application_exception": "Do not convert measured hair counts into total scalp hair count, thickness/appearance or clinical recovery.",
      "criterion": "Link Phototrichoscopy, change from baseline density and hairs/cm² to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Record hair counts, sites/areas and separate appearance/perception definitions together.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The primary endpoint was hair-density increase from baseline by TrichoScan phototrichoscopy. The original summary says this counted hairs/cm² rather than appearance or satisfaction.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Device/measurement site/area, image/hair-length conditions, repetition/reading and baseline values are unverified.",
      "missingness": "Device/measurement site/area, image/hair-length conditions, repetition/reading and baseline values are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Device/measurement site/area, image/hair-length conditions, repetition/reading and baseline values are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Instrumental methods, area/site and original density-results tables"
    },
    {
      "item_id": "N17",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the original day-180 density-change values?",
      "needed": "Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01.",
      "application_exception": "Do not subtract the numbers to create a new net effect or appearance increase, or treat ± as a CI.",
      "criterion": "Link Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Link changes, group contrasts, variability and actual n separately in original results tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original day-180 density increases were product +27.31±2.61 versus placebo +18.23±2.98 hairs/cm², P<0.01. These concern the instrumental density endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. The statistical meaning of ±, time-specific analysis n, baseline/final values and between-group effects/intervals are unverified.",
      "missingness": "The statistical meaning of ±, time-specific analysis n, baseline/final values and between-group effects/intervals are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. The statistical meaning of ±, time-specific analysis n, baseline/final values and between-group effects/intervals are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original day-180 instrumental tables, variability/denominators and analysis methods"
    },
    {
      "item_id": "N18",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What hierarchy applies to day-90 and hair-cycle-ratio results?",
      "needed": "Qualitative day-90 difference, secondary cycle ratio and separate endpoint",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Qualitative day-90 difference, secondary cycle ratio and separate endpoint.",
      "application_exception": "Do not transfer cycle ratios or qualitative day-90 findings into direct visible-fullness values, effects or duration.",
      "criterion": "Link Qualitative day-90 difference, secondary cycle ratio and separate endpoint to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish density, cycle ratio and appearance endpoints, timing and hierarchy.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original counterview describes day-90/day-180 group differences and a prespecified secondary anagen-to-catagen/telogen ratio of 8.20:1→14.19:1 versus placebo 7.43:1→8.76:1, P<0.001.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Day-90 quantities, actual ratio timing/denominators, hierarchy/plan dates and intervals/adjustment are unverified.",
      "missingness": "Day-90 quantities, actual ratio timing/denominators, hierarchy/plan dates and intervals/adjustment are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Day-90 quantities, actual ratio timing/denominators, hierarchy/plan dates and intervals/adjustment are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original density/cycle-ratio tables by time point and plans/hierarchy"
    },
    {
      "item_id": "N19",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "Are direct between-group appearance effects and CIs provided?",
      "needed": "Actual appearance contrast, numerator/scale, intervals and adjustment",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Actual appearance contrast, numerator/scale, intervals and adjustment.",
      "application_exception": "Do not calculate appearance effects, CIs or response rates from instrumental P values, ± or density changes.",
      "criterion": "Link Actual appearance contrast, numerator/scale, intervals and adjustment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If original appearance material is provided, link its measure, unit, population and estimated interval.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Density P values and absent CIs in the summary concern instrumental context. Direct selected appearance contrasts/CIs are not provided.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Appearance-score/response contrasts, baseline adjustment, models, variability and confidence intervals are unverified.",
      "missingness": "Appearance-score/response contrasts, baseline adjustment, models, variability and confidence intervals are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Appearance-score/response contrasts, baseline adjustment, models, variability and confidence intervals are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct appearance results, denominators, variability and models/intervals"
    },
    {
      "item_id": "N20",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are clinically important instrumental/appearance thresholds?",
      "needed": "Importance of hairs/cm² and direct visible/perceived-change criteria",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Importance of hairs/cm² and direct visible/perceived-change criteria.",
      "application_exception": "Do not establish meaningful visible recovery solely from positive P values or hairs/cm² increase size.",
      "criterion": "Link Importance of hairs/cm² and direct visible/perceived-change criteria to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish measure, population and prespecified/post-hoc importance criteria.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original counterview says 95% CIs and a clinically important minimum hairs/cm² threshold were not reported. No separate direct appearance threshold is provided.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Validation connecting instrumental differences to visible/perceived change, minimum appearance importance and original prespecified criteria are unverified.",
      "missingness": "Validation connecting instrumental differences to visible/perceived change, minimum appearance importance and original prespecified criteria are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Validation connecting instrumental differences to visible/perceived change, minimum appearance importance and original prespecified criteria are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Validation linking instrumental and appearance/perception outcomes and importance criteria"
    },
    {
      "item_id": "N21",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "How do appearance-assessment denominators differ from 106 randomized participants?",
      "needed": "53/53 allocation, valid appearance/responses and actual analysis by time point",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of 53/53 allocation, valid appearance/responses and actual analysis by time point.",
      "application_exception": "Do not copy 53/53 allocation as appearance-results n or add measurement areas/time points as people.",
      "criterion": "Link 53/53 allocation, valid appearance/responses and actual analysis by time point to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish people, measurement areas, time points and instrumental/appearance denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary records 106 randomized participants, 53/53. Direct appearance-assessment/response denominators are not provided.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Instrumental/appearance completion, valid responses, analysis n, areas/repeated measurements and group correspondence are unverified.",
      "missingness": "Instrumental/appearance completion, valid responses, analysis n, areas/repeated measurements and group correspondence are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Instrumental/appearance completion, valid responses, analysis n, areas/repeated measurements and group correspondence are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group flow, actual endpoint/time-specific denominators and response criteria"
    },
    {
      "item_id": "N22",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What records describe missingness, attrition and analysis populations?",
      "needed": "Instrumental/appearance analysis populations, missingness/attrition and supporting analyses",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Instrumental/appearance analysis populations, missingness/attrition and supporting analyses.",
      "application_exception": "Do not change historical missing-data uncertainty into zero dropout, complete ITT or new defect counts/scores.",
      "criterion": "Link Instrumental/appearance analysis populations, missingness/attrition and supporting analyses to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish allocation, measurement, completion, response/analysis and missingness assumptions.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original research explanation says missing-data handling details were not confirmed in the public paper. External papers/tables remain unread here.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Completion/dropout counts/reasons, ITT/PP, imputation/sensitivity, appearance-response selection and actual analysis are unverified.",
      "missingness": "Completion/dropout counts/reasons, ITT/PP, imputation/sensitivity, appearance-response selection and actual analysis are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Completion/dropout counts/reasons, ITT/PP, imputation/sensitivity, appearance-response selection and actual analysis are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original flow, analysis populations, missingness/attrition and sensitivity material"
    },
    {
      "item_id": "N23",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What actual prospective plans apply to appearance/instrumental endpoints?",
      "needed": "Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration.",
      "application_exception": "Do not promote retrospective-registration outcomes to prospective registration or original prespecified-secondary wording to current plan verification.",
      "criterion": "Link Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If plans are provided, distinguish actual prospective/retrospective timing, endpoints and hierarchy.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original primary endpoint was TrichoScan density rather than appearance. The cycle ratio is described as prespecified secondary in the original summary.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Appearance-endpoint existence/hierarchy, original protocol/SAP dates, multiplicity, selective reporting and actual prespecification are unverified.",
      "missingness": "Appearance-endpoint existence/hierarchy, original protocol/SAP dates, multiplicity, selective reporting and actual prespecification are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Appearance-endpoint existence/hierarchy, original protocol/SAP dates, multiplicity, selective reporting and actual prespecification are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration history and protocol/SAP outcomes, hierarchy and analysis"
    },
    {
      "item_id": "N24",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What original records give registration, posting and completion dates?",
      "needed": "NCT07111312, posting 2025-08-08 and completion 2024-05-10",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of NCT07111312, posting 2025-08-08 and completion 2024-05-10.",
      "application_exception": "Do not calculate elapsed time or change retrospective/original-date history into a registration lookup performed here.",
      "criterion": "Link NCT07111312, posting 2025-08-08 and completion 2024-05-10 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5, §4.6.3; limits to this material conversion reflect the review scope and Chamgap's own design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If material is provided, distinguish original dates, current reading and condition/assessment-change events.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary records NCT07111312 first posting 2025-08-08 and primary completion 2024-05-10, after-trial registration that cannot support prospective registration.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Current registration text, revision history, original plans and individual-endpoint/completion material are unread.",
      "missingness": "Current registration text, revision history, original plans and individual-endpoint/completion material are unread.",
      "uncertainty": "Within the production scope of the preserved summary. Current registration text, revision history, original plans and individual-endpoint/completion material are unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original registration/history, protocol/SAP and actual trial timeline"
    },
    {
      "item_id": "N25",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What are the report identity and actual preserved-summary locations?",
      "needed": "SáezMoya2025·CT-OW-02·PMID41288927",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Sáez Moya 2025, CT-OW-02 and PMID 41288927.",
      "application_exception": "Do not infer DOI/PMCID from PMID or create additional slots/trials from other-product reports.",
      "criterion": "Link Sáez Moya 2025, CT-OW-02 and PMID 41288927 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "When bibliography is supplemented, preserve original wording, report identity and change events.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "R01 is Sáez Moya M et al., 2025 CT-OW-02, Dermatol Ther (Heidelb), PMID 41288927, linked to the first original evidence and citation records.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. DOI, PMCID, current external bibliography/full text and original appearance-results locations are not provided.",
      "missingness": "DOI, PMCID, current external bibliography/full text and original appearance-results locations are not provided.",
      "uncertainty": "Within the production scope of the preserved summary. DOI, PMCID, current external bibliography/full text and original appearance-results locations are not provided.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original bibliography, full text and registration/product/population links"
    },
    {
      "item_id": "N26",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "Are subquestions, time points and hair measures kept separate from independent replication?",
      "needed": "The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance.",
      "application_exception": "Do not add days 90/180, hair cycle/areas, parent/sibling sheets or report/material slots as independent trials/participants.",
      "criterion": "Link The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish the same population/re-reporting from different recruitment/trials in additional reports.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "One manufacturer trial in the summary contains instrumental density and other endpoints/time points in the same report. Selected appearance has a direct-evidence gap.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Unique trial/participant totals and independent replication were not newly searched, summed or certified.",
      "missingness": "Unique trial/participant totals and independent replication were not newly searched, summed or certified.",
      "uncertainty": "Within the production scope of the preserved summary. Unique trial/participant totals and independent replication were not newly searched, summed or certified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial-report-person-time-area-endpoint links"
    },
    {
      "item_id": "N27",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What were actual manufacturer roles and author relationships?",
      "needed": "Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author.",
      "application_exception": "Do not hide manufacturer roles or turn one manufacturer trial into current independence certification or a data-manipulation finding.",
      "criterion": "Link Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "If disclosures are provided, distinguish product supply, funding, sponsor, employee author and analysis/publication.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original rationale records Olistic Research Labs S.L. fully paying research/publication fees, sponsorship/responsibility, product/placebo supply and Manuel Sáez Moya company affiliation.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Original disclosures of analysis/writing/publication decisions, data access, other authors/relationships and current contracts are unread.",
      "missingness": "Original disclosures of analysis/writing/publication decisions, data access, other authors/relationships and current contracts are unread.",
      "uncertainty": "Within the production scope of the preserved summary. Original disclosures of analysis/writing/publication decisions, data access, other authors/relationships and current contracts are unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original support, product/placebo, author disclosures and analysis/publication roles"
    },
    {
      "item_id": "N28",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "Can this extend to other products, formulations, ingredients, populations or durability?",
      "needed": "Olistic Women finished product, selected population and other products/long-term outcomes",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Olistic Women finished product, selected population and other products/long-term outcomes.",
      "application_exception": "Do not write other-brand/ingredient or general hair-loss benefit/safety, consumption or treatment guidance.",
      "criterion": "Link Olistic Women finished product, selected population and other products/long-term outcomes to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Link actual finished product, population, exposure and endpoints separately in new material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary says results cannot extend to Viviscal, Nutrafol or the supplement class and do not establish visible fullness, durability or other-formulation effects.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Other products/ingredients, populations, doses/durations and direct appearance/long-term/post-discontinuation outcomes are unverified within this reading scope.",
      "missingness": "Other products/ingredients, populations, doses/durations and direct appearance/long-term/post-discontinuation outcomes are unverified within this reading scope.",
      "uncertainty": "Within the production scope of the preserved summary. Other products/ingredients, populations, doses/durations and direct appearance/long-term/post-discontinuation outcomes are unverified within this reading scope.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct comparisons and appearance results for actual other formulations/populations/durations"
    },
    {
      "item_id": "N29",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "How are original dates, corrections, Korean/English texts, axes and history preserved?",
      "needed": "2026-08-26, empty corrections/deliberation and original assessment",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of 2026-08-26, empty corrections/deliberation and original assessment.",
      "application_exception": "Do not fill absent/empty values or historical cross-checks with new scores/axes or completed review.",
      "criterion": "Link 2026-08-26, empty corrections/deliberation and original assessment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish complete pre-change text, events, versions and separate application when changes occur.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The cut-off is 2026-08-26, corrections are an empty array and deliberation an empty string. Complete preservation retains Korean/English text, synthesis/assessment decisions, axes, false flags and precision null.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Classification and primary_failed_secondary_positive keys are absent. Empty corrections are not a current external correction/retraction check.",
      "missingness": "Classification and primary_failed_secondary_positive keys are absent. Empty corrections are not a current external correction/retraction check.",
      "uncertainty": "Within the production scope of the preserved summary. Classification and primary_failed_secondary_positive keys are absent. Empty corrections are not a current external correction/retraction check.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Complete previous summary and actual change/correction events"
    },
    {
      "item_id": "N30",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What was actually read and what are external-material states?",
      "needed": "Complete preserved 2956 summary, selected original record and summary/external distinction",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Complete preserved 2956 summary, selected original record and summary/external distinction.",
      "application_exception": "Do not promote URLs, historical paper/registration wording or copies into full-text reading, successful access or link checks.",
      "criterion": "Link Complete preserved 2956 summary, selected original record and summary/external distinction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish material type, publication/access, acquisition and actual reading scope/dates in new material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The selected original record and complete preserved 2956 summary were read for production. Distinguish one report summary from unread external/required-material slots.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. External abstracts, full texts, registration, plans, original results/harms and disclosures were not accessed or acquired.",
      "missingness": "External abstracts, full texts, registration, plans, original results/harms and disclosures were not accessed or acquired.",
      "uncertainty": "Within the production scope of the preserved summary. External abstracts, full texts, registration, plans, original results/harms and disclosures were not accessed or acquired.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "User-provided originals and actual acquisition/reading records"
    },
    {
      "item_id": "N31",
      "question_type": "Appearance, patient perception, instrumental context and materials",
      "question": "What is linked when new material or corrections become available?",
      "needed": "Condition version, originals, observations, reading and change event",
      "role": "Required",
      "role_reason": "Production condition to record the actual scope of Condition version, originals, observations, reading and change event.",
      "application_exception": "Original candidate pending/eligibility states are historical; do not revive active model/content/boundary-review waits.",
      "criterion": "Link Condition version, originals, observations, reading and change event to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Separate actual additions/changes into complete prior versions, events, condition versions/freezing, separate application and current handoff.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original appearance question and parent instrumental context are rendered in the same seven-column format. Conditions were saved/frozen first with separate application timing.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. No new clinical search, calculation, evidence/effect, reassessment, independence certification or model/self content review was performed.",
      "missingness": "No new clinical search, calculation, evidence/effect, reassessment, independence certification or model/self content review was performed.",
      "uncertainty": "Within the production scope of the preserved summary. No new clinical search, calculation, evidence/effect, reassessment, independence certification or model/self content review was performed.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "User-provided direct appearance/patient assessments, denominators, plans, harms/corrections"
    },
    {
      "item_id": "H01",
      "question_type": "Harms",
      "question": "Were minor adverse events actually collected?",
      "needed": "Original minor-AE noncollection, definitions/collection and relatedness",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Original minor-AE noncollection, definitions/collection and relatedness.",
      "application_exception": "Do not change minor-event noncollection into no events, good tolerability or access failure.",
      "criterion": "Link Original minor-AE noncollection, definitions/collection and relatedness to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish minor/serious events by actual collection scope and relatedness in subsequent material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary preserves the authors' explicit statement that minor adverse events were not collected at all and that general tolerability therefore cannot be assessed.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Actual minor-event types/frequencies, full collection definitions and relatedness are unverified. The original external wording was not read here.",
      "missingness": "Actual minor-event types/frequencies, full collection definitions and relatedness are unverified. The original external wording was not read here.",
      "uncertainty": "Within the production scope of the preserved summary. Actual minor-event types/frequencies, full collection definitions and relatedness are unverified. The original external wording was not read here.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original harm-collection plans, definitions, full results and disclosed wording"
    },
    {
      "item_id": "H02",
      "question_type": "Harms",
      "question": "What were actual safety-observation periods and exposure?",
      "needed": "Six-month trial exposure, harm-collection periods and post-discontinuation follow-up",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Six-month trial exposure, harm-collection periods and post-discontinuation follow-up.",
      "application_exception": "Do not turn six-month follow-up alone into comprehensive safety collection or long-term safety assurance.",
      "criterion": "Link Six-month trial exposure, harm-collection periods and post-discontinuation follow-up to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Report the original trial period and actual collection/follow-up periods separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original product exposure was six months; minor-event noncollection prevents general tolerability assessment.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Serious/other harm-collection periods, collection by visit, stopping/follow-up courses and actual exposure are unverified.",
      "missingness": "Serious/other harm-collection periods, collection by visit, stopping/follow-up courses and actual exposure are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Serious/other harm-collection periods, collection by visit, stopping/follow-up courses and actual exposure are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Periods/exposure, collection schedules and stopping/follow-up harm material"
    },
    {
      "item_id": "H03",
      "question_type": "Harms",
      "question": "Are group-specific product/placebo harm comparisons available?",
      "needed": "Related/all, serious/minor, group-specific events and comparison",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Related/all, serious/minor, group-specific events and comparison.",
      "application_exception": "Do not confirm zero serious events or safety equivalence from absent group-specific quantities.",
      "criterion": "Link Related/all, serious/minor, group-specific events and comparison to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Link group definitions, collection, periods and effects/intervals separately in direct harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The summary records minor-event noncollection and safety gaps without providing quantitative group-specific harms.",
      "condition_status": "Unverified",
      "status_reason": "Direct definitions, values and material needed within the preserved-summary/unread-external scope are unverified. Actual product/placebo events, severity/relatedness, intervals and comparable collection are unverified.",
      "missingness": "Actual product/placebo events, severity/relatedness, intervals and comparable collection are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Actual product/placebo events, severity/relatedness, intervals and comparable collection are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group-specific all/serious harms, relatedness and collection/denominator tables"
    },
    {
      "item_id": "H04",
      "question_type": "Harms",
      "question": "How do safety denominators differ from allocation/analysis denominators?",
      "needed": "53/53 allocation, actual exposure/safety collection and endpoint-specific n",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of 53/53 allocation, actual exposure/safety collection and endpoint-specific n.",
      "application_exception": "Do not copy 53/53 allocation as collection denominators for all harms or calculate incidence.",
      "criterion": "Link 53/53 allocation, actual exposure/safety collection and endpoint-specific n to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish allocation, exposure, collection and completion/analysis denominators in harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The 106 participants, 53/53, in the summary are randomized counts. Minor events were not collected.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Actual safety exposure/completion, collection/analysis n, group exclusion/stopping and serious-event denominators are unverified.",
      "missingness": "Actual safety exposure/completion, collection/analysis n, group exclusion/stopping and serious-event denominators are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Actual safety exposure/completion, collection/analysis n, group exclusion/stopping and serious-event denominators are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exposure, stopping, safety populations/denominators and original flow"
    },
    {
      "item_id": "H05",
      "question_type": "Harms",
      "question": "What are multi-ingredient, baseline, concurrent-exposure and relatedness records?",
      "needed": "Finished product, individual ingredients, baseline/concurrent management and harm relatedness",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Finished product, individual ingredients, baseline/concurrent management and harm relatedness.",
      "application_exception": "Do not invent unrecorded allergy/interaction cases as observed events or newly attribute product harm to an ingredient.",
      "criterion": "Link Finished product, individual ingredients, baseline/concurrent management and harm relatedness to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish finished product, individual ingredients and baseline/concurrent factors in direct harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original exposure concerned a particular drinkable multi-ingredient finished product. Minor harms were outside the original collection scope.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Ingredient quantities, concurrent supplements/medication, baseline disease, actual cases, alternative factors and relatedness judgments are unverified.",
      "missingness": "Ingredient quantities, concurrent supplements/medication, baseline disease, actual cases, alternative factors and relatedness judgments are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Ingredient quantities, concurrent supplements/medication, baseline disease, actual cases, alternative factors and relatedness judgments are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Product composition, concurrent exposure, actual cases and relatedness review"
    },
    {
      "item_id": "H06",
      "question_type": "Harms",
      "question": "Are noncollection, nonreporting, unread material and zero events distinguished?",
      "needed": "Original minor-AE noncollection, currently unread external material and other-harm states",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Original minor-AE noncollection, currently unread external material and other-harm states.",
      "application_exception": "Do not change minor-AE noncollection or current nonreading into all events zero, absent papers or access failure.",
      "criterion": "Link Original minor-AE noncollection, currently unread external material and other-harm states to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish collection scope, nonreporting/missingness and actual zero only within provided material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original record describes minor-event noncollection; external full texts/tables are currently unread. These remain distinct states.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Actual noncollection/nonreporting/missingness/zero distinctions for other harms and serious-event originals are unverified.",
      "missingness": "Actual noncollection/nonreporting/missingness/zero distinctions for other harms and serious-event originals are unverified.",
      "uncertainty": "Within the production scope of the preserved summary. Actual noncollection/nonreporting/missingness/zero distinctions for other harms and serious-event originals are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Full safety collection/results, omission reasons and reading records"
    },
    {
      "item_id": "H07",
      "question_type": "Harms",
      "question": "Are manufacturer reports, time points and questions kept separate from duplicate totals?",
      "needed": "The same CT-OW-02, 106 participants and instrumental/appearance/harm family",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of The same CT-OW-02, 106 participants and instrumental/appearance/harm family.",
      "application_exception": "Do not add material slots, two subquestions, time points or areas as independent trials, participants or events.",
      "criterion": "Link The same CT-OW-02, 106 participants and instrumental/appearance/harm family to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Distinguish re-reporting of the same events from new trials/events in additional harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Days 90/180, density/cycle ratio and appearance questions in one report remain one trial context. Direct appearance effects/harms are separately unverified.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. New independent harm reports, duplicated events/people and other recruitment populations were not verified here.",
      "missingness": "New independent harm reports, duplicated events/people and other recruitment populations were not verified here.",
      "uncertainty": "Within the production scope of the preserved summary. New independent harm reports, duplicated events/people and other recruitment populations were not verified here.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial-person-time-endpoint-event-report links"
    },
    {
      "item_id": "H08",
      "question_type": "Harms",
      "question": "What long-term safety gaps concern other populations, periods and products?",
      "needed": "Premenopausal telogen effluvium, finished product, six months and other conditions",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Premenopausal telogen effluvium, finished product, six months and other conditions.",
      "application_exception": "Do not turn positive instrumental findings into long-term supplement safety or consumption/treatment guidance.",
      "criterion": "Link Premenopausal telogen effluvium, finished product, six months and other conditions to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "State actual population, finished product/exposure, period and collection level in new harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Parent safety is Unknown and the trial concerns a particular finished product and selected population.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. Longer/different exposures, other products/ingredients, postmenopausal/other populations and disease/medication-specific direct harms are unverified in this scope.",
      "missingness": "Longer/different exposures, other products/ingredients, postmenopausal/other populations and disease/medication-specific direct harms are unverified in this scope.",
      "uncertainty": "Within the production scope of the preserved summary. Longer/different exposures, other products/ingredients, postmenopausal/other populations and disease/medication-specific direct harms are unverified in this scope.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct harms by population/product/period and long-term collection"
    },
    {
      "item_id": "H09",
      "question_type": "Harms",
      "question": "Are instrumental signals, appearance gaps and Unknown safety retained together?",
      "needed": "Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps",
      "role": "Supporting harm information",
      "role_reason": "Production condition to record the actual scope of Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps.",
      "application_exception": "Do not change instrumental positivity into appearance benefit or safety assurance, or appearance gaps into zero effect or treatment recommendations.",
      "criterion": "Link Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.",
      "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run",
      "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately",
      "proposed_research": "Link each instrumental, appearance and harm endpoint, original location and change event separately in additional material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved summary linked; existence/current publication of needed external details unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Distinguish positive parent instrumental density from selected appearance ? while retaining minor-event noncollection and Unknown safety.",
      "condition_status": "Partly verified",
      "status_reason": "Original summary information is linked for production; clinical verification, condition fulfillment and content review are not complete. No new benefit-harm synthesis, treatment/product selection or independence/causal certification was performed.",
      "missingness": "No new benefit-harm synthesis, treatment/product selection or independence/causal certification was performed.",
      "uncertainty": "Within the production scope of the preserved summary. No new benefit-harm synthesis, treatment/product selection or independence/causal certification was performed.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct appearance/patient results, harms and original follow-up material"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Sáez Moya M, et al. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium. Dermatol Ther (Heidelb). 2025. PMID: 41288927.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/41288927/",
      "report_type": "CT-OW-02 multicenter double-blind placebo-controlled finished-product trial",
      "existence": "Bibliography/URL retained from the preserved-summary citation list",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "Olistic Women · CT-OW-02 · NCT07111312 original population",
      "independent_replication": false,
      "observed_result": "+27.31±2.61 versus +18.23±2.98 hairs/cm², P<0.01; 95% CI not reported. Instrumental density results, not direct selected appearance/patient-perception effects. Distinguish original subclaim ? and the note that appearance was not primary.",
      "result_level": "First original evidence record: instrumental endpoint and parent appearance/harm boundaries",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Local copy acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-06T16:50:59.988098+09:00",
          "qualification": "Production reading of complete preserved 2956 bibliography, instrumental/appearance boundaries and registration/support/harm context; external paper not read."
        },
        {
          "material_type": "External abstract",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation URL is linked; current abstract contents/access unverified."
        },
        {
          "material_type": "External full text",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original report-identity source link is connected; current full-text location/publication/access unverified."
        },
        {
          "material_type": "Registration",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original registration identifier and retrospective-registration dates retained; no current contents/history lookup."
        },
        {
          "material_type": "Protocol",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material slot; actual file existence/publication, appearance/instrumental hierarchy and prospective plans unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material slot for appearance/instrumental denominators, models, multiple comparisons, missingness and selective analysis."
        },
        {
          "material_type": "Results, denominator and harm details",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required originals for actual appearance results, denominators, intervals, instrumental contrasts and collected harms. Do not change noncollection/nonreading into zero."
        },
        {
          "material_type": "Support and interests",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Distinguish original full funding, sponsorship, supply and employee-author context from current external disclosures."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/41288927/"
        }
      ]
    }
  ],
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "One preserved-summary report for the same CT-OW-02/Olistic Women finished product and selected population of women. Do not add days 90/180, density/cycle ratio or parent/subclaim sheets as new independent trials or participants."
  },
  "history": [
    {
      "date": "2026-10-12",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-12"
}