Olistic Women · Direct-evidence gaps for visibly fuller hair

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Appearance, patient perception, instrumental context and materialsWhat are the selected original question and assessment record?Required	The selected original question and assessment record concern visibly fuller hair. Parent and sibling TrichoScan hair-density questions concern a different endpoint. R01	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.	Original visibly fuller hair wording, Korean/English texts and link	If the question changes, retain original wording, the previous complete version and the change event.
2	Partly verified	Full text not readStored summary read	N02 · Appearance, patient perception, instrumental context and materialsHow do the subclaim ? and parent C50, axes and history differ?Required	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. R01	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.	Subclaim grade/note, absent score/status/axes and actual parent values	Distinguish actual evidence-update events from preservation of original values.
3	Partly verified	Full text not readStored summary read	N03 · Appearance, patient perception, instrumental context and materialsWhich selected population of women entered the finished-product trial?Required	CT-OW-02 was a multicenter trial in 106 premenopausal women diagnosed with telogen effluvium. R01	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.	Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection	Distinguish other-population material by actual diagnosis, menopausal status, baseline characteristics and selection.
4	Partly verified	Full text not readStored summary read	N04 · Appearance, patient perception, instrumental context and materialsWhat material describes baseline appearance, hair loss and diagnosis?Required	The original summary records telogen-effluvium diagnosis and TrichoScan results without providing direct selected appearance-assessment material. R01	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.	Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment	Record actual baseline diagnosis and starting appearance when appearance-change material becomes available.
5	Partly verified	Full text not readStored summary read	N05 · Appearance, patient perception, instrumental context and materialsWhat are the finished product and ingredient scope?Required	The original product is Olistic Women drinkable multi-ingredient nutraceutical. The manufacturer is recorded as supplying trial product and placebo. R01	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.	Olistic Women drinkable multi-ingredient finished product, formulation and composition	If material is provided, distinguish the finished product from individual ingredients and other formulations.
6	Partly verified	Full text not readStored summary read	N06 · Appearance, patient perception, instrumental context and materialsWhat were the original trial exposure and actual implementation?Required	Original product information describes a finished-product trial of one 25-mL vial daily for six months. This preserves trial exposure. R01	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.	One 25-mL vial daily for six months and actual adherence/exposure	Distinguish nominal exposure from actual implementation in subsequent material.
7	Partly verified	Full text not readStored summary read	N07 · Appearance, patient perception, instrumental context and materialsWhat were the placebo and common conditions?Required	CT-OW-02 was placebo-controlled; the company is recorded as supplying product and placebo. R01	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.	Manufacturer-supplied placebo, actual composition/appearance and comparison direction	Distinguish the actual product/placebo contrast from comparisons with other ingredients.
8	Partly verified	Full text not readStored summary read	N08 · Appearance, patient perception, instrumental context and materialsWhat were randomization and actual analysis scopes?Required	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. R01	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.	106 participants, 53/53 allocation, sequence/concealment and completion/analysis	If original material is provided, distinguish allocation from actual completion/analysis and measurement level.
9	Partly verified	Full text not readStored summary read	N09 · Appearance, patient perception, instrumental context and materialsWhat were double-blinding and appearance-assessor conditions?Required	The original design was a multicenter double-blind placebo-controlled randomized trial. R01	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.	Participants/measurers, photograph/appearance reading and maintained blinding	Record patient/independent-assessor blinding and consistent assessment conditions in appearance material.
10	Unverified	Full text not readStored summary read	N10 · Appearance, patient perception, instrumental context and materialsWhat were concurrent hair care, treatment and natural course?Required	The summary records instrumental results for a particular finished product and placebo. R01	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.	Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery	Distinguish finished-product exposure from concurrent management/natural course in later appearance material.
11	Unverified	Full text not readStored summary read	N11 · Appearance, patient perception, instrumental context and materialsWhat is the direct endpoint for visibly fuller hair?Required	The original subclaim note says appearance was not the primary endpoint. The parent distinguishes TrichoScan counts from patient perception. R01	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.	Visible fullness definition, observer and patient perception	Report actual appearance assessor, definition, timing and denominator separately from instrumental counts.
12	Unverified	Full text not readStored summary read	N12 · Appearance, patient perception, instrumental context and materialsWhat are the appearance scale and units of visible change?Required	The summary provides no direct appearance-change score, unit or response category. R01	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.	Visible change, scale, photograph/assessment and direction	State scale direction, observer and change definition in appearance material.
13	Unverified	Full text not readStored summary read	N13 · Appearance, patient perception, instrumental context and materialsIs actual standardized-photograph or independent-assessment material available?Required	The original summary only provides the boundary that appearance assessment was not the primary endpoint. R01	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.	Photographs/independent observation, consistent conditions, blinding and judgment	State assessment conditions, independence and judgment level in later appearance material.
14	Unverified	Full text not readStored summary read	N14 · Appearance, patient perception, instrumental context and materialsWhat are the direct patient-perception, satisfaction and quality-of-life values?Required	The original reader answer distinguishes perceived visible fullness from instrumental counts. R01	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.	Distinguish patient perception, appearance/satisfaction and symptoms/quality of life	Record instrumental counts, appearance observation, satisfaction and quality of life as separate endpoints.
15	Unverified	Full text not readStored summary read	N15 · Appearance, patient perception, instrumental context and materialsWhat are appearance-assessment timing and durability?Required	The original trial describes six months and day-90/day-180 instrumental results. Actual selected appearance measurement/follow-up is not separately provided. R01	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.	Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up	Distinguish on-treatment measurement from post-discontinuation persistence by actual timing and denominator.
16	Partly verified	Full text not readStored summary read	N16 · Appearance, patient perception, instrumental context and materialsWhat separate measurement is the TrichoScan endpoint?Required	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. R01	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.	Phototrichoscopy, change from baseline density and hairs/cm²	Record hair counts, sites/areas and separate appearance/perception definitions together.
17	Partly verified	Full text not readStored summary read	N17 · Appearance, patient perception, instrumental context and materialsWhat are the original day-180 density-change values?Required	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. R01	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.	Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01	Link changes, group contrasts, variability and actual n separately in original results tables.
18	Partly verified	Full text not readStored summary read	N18 · Appearance, patient perception, instrumental context and materialsWhat hierarchy applies to day-90 and hair-cycle-ratio results?Required	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. R01	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.	Qualitative day-90 difference, secondary cycle ratio and separate endpoint	Distinguish density, cycle ratio and appearance endpoints, timing and hierarchy.
19	Unverified	Full text not readStored summary read	N19 · Appearance, patient perception, instrumental context and materialsAre direct between-group appearance effects and CIs provided?Required	Density P values and absent CIs in the summary concern instrumental context. Direct selected appearance contrasts/CIs are not provided. R01	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.	Actual appearance contrast, numerator/scale, intervals and adjustment	If original appearance material is provided, link its measure, unit, population and estimated interval.
20	Unverified	Full text not readStored summary read	N20 · Appearance, patient perception, instrumental context and materialsWhat are clinically important instrumental/appearance thresholds?Required	The original counterview says 95% CIs and a clinically important minimum hairs/cm² threshold were not reported. No separate direct appearance threshold is provided. R01	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.	Importance of hairs/cm² and direct visible/perceived-change criteria	Distinguish measure, population and prespecified/post-hoc importance criteria.
21	Unverified	Full text not readStored summary read	N21 · Appearance, patient perception, instrumental context and materialsHow do appearance-assessment denominators differ from 106 randomized participants?Required	The summary records 106 randomized participants, 53/53. Direct appearance-assessment/response denominators are not provided. R01	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.	53/53 allocation, valid appearance/responses and actual analysis by time point	Distinguish people, measurement areas, time points and instrumental/appearance denominators.
22	Partly verified	Full text not readStored summary read	N22 · Appearance, patient perception, instrumental context and materialsWhat records describe missingness, attrition and analysis populations?Required	The original research explanation says missing-data handling details were not confirmed in the public paper. External papers/tables remain unread here. R01	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.	Instrumental/appearance analysis populations, missingness/attrition and supporting analyses	Distinguish allocation, measurement, completion, response/analysis and missingness assumptions.
23	Partly verified	Full text not readStored summary read	N23 · Appearance, patient perception, instrumental context and materialsWhat actual prospective plans apply to appearance/instrumental endpoints?Required	The original primary endpoint was TrichoScan density rather than appearance. The cycle ratio is described as prespecified secondary in the original summary. R01	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.	Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration	If plans are provided, distinguish actual prospective/retrospective timing, endpoints and hierarchy.
24	Partly verified	Full text not readStored summary read	N24 · Appearance, patient perception, instrumental context and materialsWhat original records give registration, posting and completion dates?Required	The summary records NCT07111312 first posting 2025-08-08 and primary completion 2024-05-10, after-trial registration that cannot support prospective registration. R01	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.	NCT07111312, posting 2025-08-08 and completion 2024-05-10	If material is provided, distinguish original dates, current reading and condition/assessment-change events.
25	Partly verified	Full text not readStored summary read	N25 · Appearance, patient perception, instrumental context and materialsWhat are the report identity and actual preserved-summary locations?Required	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. R01	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.	SáezMoya2025·CT-OW-02·PMID41288927	When bibliography is supplemented, preserve original wording, report identity and change events.
26	Partly verified	Full text not readStored summary read	N26 · Appearance, patient perception, instrumental context and materialsAre subquestions, time points and hair measures kept separate from independent replication?Required	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. R01	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.	The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance	Distinguish the same population/re-reporting from different recruitment/trials in additional reports.
27	Partly verified	Full text not readStored summary read	N27 · Appearance, patient perception, instrumental context and materialsWhat were actual manufacturer roles and author relationships?Required	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. R01	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.	Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author	If disclosures are provided, distinguish product supply, funding, sponsor, employee author and analysis/publication.
28	Partly verified	Full text not readStored summary read	N28 · Appearance, patient perception, instrumental context and materialsCan this extend to other products, formulations, ingredients, populations or durability?Required	The summary says results cannot extend to Viviscal, Nutrafol or the supplement class and do not establish visible fullness, durability or other-formulation effects. R01	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.	Olistic Women finished product, selected population and other products/long-term outcomes	Link actual finished product, population, exposure and endpoints separately in new material.
29	Partly verified	Full text not readStored summary read	N29 · Appearance, patient perception, instrumental context and materialsHow are original dates, corrections, Korean/English texts, axes and history preserved?Required	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. R01	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.	2026-08-26, empty corrections/deliberation and original assessment	Distinguish complete pre-change text, events, versions and separate application when changes occur.
30	Partly verified	Full text not readStored summary read	N30 · Appearance, patient perception, instrumental context and materialsWhat was actually read and what are external-material states?Required	The selected original record and complete preserved 2956 summary were read for production. Distinguish one report summary from unread external/required-material slots. R01	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.	Complete preserved 2956 summary, selected original record and summary/external distinction	Distinguish material type, publication/access, acquisition and actual reading scope/dates in new material.
31	Partly verified	Full text not readStored summary read	N31 · Appearance, patient perception, instrumental context and materialsWhat is linked when new material or corrections become available?Required	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. R01	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.	Condition version, originals, observations, reading and change event	Separate actual additions/changes into complete prior versions, events, condition versions/freezing, separate application and current handoff.
32	Partly verified	Full text not readStored summary read	H01 · HarmsWere minor adverse events actually collected?Supporting harm information	The summary preserves the authors' explicit statement that minor adverse events were not collected at all and that general tolerability therefore cannot be assessed. R01	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.	Original minor-AE noncollection, definitions/collection and relatedness	Distinguish minor/serious events by actual collection scope and relatedness in subsequent material.
33	Partly verified	Full text not readStored summary read	H02 · HarmsWhat were actual safety-observation periods and exposure?Supporting harm information	Original product exposure was six months; minor-event noncollection prevents general tolerability assessment. R01	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.	Six-month trial exposure, harm-collection periods and post-discontinuation follow-up	Report the original trial period and actual collection/follow-up periods separately.
34	Unverified	Full text not readStored summary read	H03 · HarmsAre group-specific product/placebo harm comparisons available?Supporting harm information	The summary records minor-event noncollection and safety gaps without providing quantitative group-specific harms. R01	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.	Related/all, serious/minor, group-specific events and comparison	Link group definitions, collection, periods and effects/intervals separately in direct harm material.
35	Partly verified	Full text not readStored summary read	H04 · HarmsHow do safety denominators differ from allocation/analysis denominators?Supporting harm information	The 106 participants, 53/53, in the summary are randomized counts. Minor events were not collected. R01	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.	53/53 allocation, actual exposure/safety collection and endpoint-specific n	Distinguish allocation, exposure, collection and completion/analysis denominators in harm material.
36	Partly verified	Full text not readStored summary read	H05 · HarmsWhat are multi-ingredient, baseline, concurrent-exposure and relatedness records?Supporting harm information	Original exposure concerned a particular drinkable multi-ingredient finished product. Minor harms were outside the original collection scope. R01	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.	Finished product, individual ingredients, baseline/concurrent management and harm relatedness	Distinguish finished product, individual ingredients and baseline/concurrent factors in direct harm material.
37	Partly verified	Full text not readStored summary read	H06 · HarmsAre noncollection, nonreporting, unread material and zero events distinguished?Supporting harm information	The original record describes minor-event noncollection; external full texts/tables are currently unread. These remain distinct states. R01	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.	Original minor-AE noncollection, currently unread external material and other-harm states	Distinguish collection scope, nonreporting/missingness and actual zero only within provided material.
38	Partly verified	Full text not readStored summary read	H07 · HarmsAre manufacturer reports, time points and questions kept separate from duplicate totals?Supporting harm information	Days 90/180, density/cycle ratio and appearance questions in one report remain one trial context. Direct appearance effects/harms are separately unverified. R01	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.	The same CT-OW-02, 106 participants and instrumental/appearance/harm family	Distinguish re-reporting of the same events from new trials/events in additional harm material.
39	Partly verified	Full text not readStored summary read	H08 · HarmsWhat long-term safety gaps concern other populations, periods and products?Supporting harm information	Parent safety is Unknown and the trial concerns a particular finished product and selected population. R01	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.	Premenopausal telogen effluvium, finished product, six months and other conditions	State actual population, finished product/exposure, period and collection level in new harm material.
40	Partly verified	Full text not readStored summary read	H09 · HarmsAre instrumental signals, appearance gaps and Unknown safety retained together?Supporting harm information	Distinguish positive parent instrumental density from selected appearance ? while retaining minor-event noncollection and Unknown safety. R01	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.	Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps	Link each instrumental, appearance and harm endpoint, original location and change event separately in additional material.

No items match your search or filter.

40 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 106 premenopausal women diagnosed with telogen effluvium, allocated 53/53. Detailed diagnosis/baseline and appearance-response/analysis populations are unverified.
Ingredient, formulation and route: 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.
Measured outcome: 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.
Questions outside this scope: 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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Sáez Moya M, et al. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium. Dermatol Ther (Heidelb). 2025. PMID: 41288927.

PubMed

Material type: CT-OW-02 multicenter double-blind placebo-controlled finished-product trial
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: +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.
Record level: First original evidence record: instrumental endpoint and parent appearance/harm boundaries
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Local copy acquired	Summary read	Production reading of complete preserved 2956 bibliography, instrumental/appearance boundaries and registration/support/harm context; external paper not read.
External abstract	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original citation URL is linked; current abstract contents/access unverified.
External full text	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original report-identity source link is connected; current full-text location/publication/access unverified.
Registration	Current publication/access unverified	Access not attempted; not obtained	Not read	Original registration identifier and retrospective-registration dates retained; no current contents/history lookup.
Protocol	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material slot; actual file existence/publication, appearance/instrumental hierarchy and prospective plans unverified.
Statistical analysis plan	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material slot for appearance/instrumental denominators, models, multiple comparisons, missingness and selective analysis.
Results, denominator and harm details	Current publication/access unverified	Access not attempted; not obtained	Not read	Required originals for actual appearance results, denominators, intervals, instrumental contrasts and collected harms. Do not change noncollection/nonreading into zero.
Support and interests	Current publication/access unverified	Access not attempted; not obtained	Not read	Distinguish original full funding, sponsorship, supply and employee-author context from current external disclosures.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected original question and assessment record?

Required materials and conditions: Original visibly fuller hair wording, Korean/English texts and link
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not count instrumental and appearance questions in one report as new independent trials or participants.
Why this condition is needed: Production condition to record the actual scope of Original visibly fuller hair wording, Korean/English texts and link.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

N02 · How do the subclaim ? and parent C50, axes and history differ?

Required materials and conditions: Subclaim grade/note, absent score/status/axes and actual parent values
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not transfer parent measured-density C50 or historical cross-checks into a new appearance assessment, score or completed content review.
Why this condition is needed: Production condition to record the actual scope of Subclaim grade/note, absent score/status/axes and actual parent values.
Referenced methods: 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

N03 · Which selected population of women entered the finished-product trial?

Required materials and conditions: Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not generalize to all female hair loss, men, postmenopausal women, other hair-loss types or deficiency populations.
Why this condition is needed: Production condition to record the actual scope of Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N04 · What material describes baseline appearance, hair loss and diagnosis?

Required materials and conditions: Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not create clinical hair-loss severity, baseline perception or differential diagnoses from TrichoScan numbers alone.
Why this condition is needed: Production condition to record the actual scope of Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation

N05 · What are the finished product and ingredient scope?

Required materials and conditions: Olistic Women drinkable multi-ingredient finished product, formulation and composition
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not fill in unrecorded biotin/vitamins/botanicals or attribute an effect to an individual ingredient.
Why this condition is needed: Production condition to record the actual scope of Olistic Women drinkable multi-ingredient finished product, formulation and composition.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

N06 · What were the original trial exposure and actual implementation?

Required materials and conditions: One 25-mL vial daily for six months and actual adherence/exposure
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not write consumption, product-selection, dosing, dose-conversion or treatment instructions.
Why this condition is needed: Production condition to record the actual scope of One 25-mL vial daily for six months and actual adherence/exposure.
Referenced methods: 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

N07 · What were the placebo and common conditions?

Required materials and conditions: Manufacturer-supplied placebo, actual composition/appearance and comparison direction
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not change placebo into no treatment or an unrecorded active comparator.
Why this condition is needed: Production condition to record the actual scope of Manufacturer-supplied placebo, actual composition/appearance and comparison direction.
Referenced methods: 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

N08 · What were randomization and actual analysis scopes?

Required materials and conditions: 106 participants, 53/53 allocation, sequence/concealment and completion/analysis
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not copy 53/53 as verified analysis denominators for every time point/appearance endpoint or assign new methodological-defect scores.
Why this condition is needed: Production condition to record the actual scope of 106 participants, 53/53 allocation, sequence/concealment and completion/analysis.
Referenced methods: 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

N09 · What were double-blinding and appearance-assessor conditions?

Required materials and conditions: Participants/measurers, photograph/appearance reading and maintained blinding
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not confirm separate appearance assessment or blinding of every assessor from the design label alone.
Why this condition is needed: Production condition to record the actual scope of Participants/measurers, photograph/appearance reading and maintained blinding.
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

N10 · What were concurrent hair care, treatment and natural course?

Required materials and conditions: Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not write new treatment, washing/cosmetic or hair-care methods or calculate natural recovery.
Why this condition is needed: Production condition to record the actual scope of Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N11 · What is the direct endpoint for visibly fuller hair?

Required materials and conditions: Visible fullness definition, observer and patient perception
Conditions for verification: Link Visible fullness definition, observer and patient perception to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.
Requirement and applicability: Required
Application exceptions: Do not present density change or the question wording as observed appearance improvement.
Why this condition is needed: Production condition to record the actual scope of Visible fullness definition, observer and patient perception.
Referenced methods: 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

N12 · What are the appearance scale and units of visible change?

Required materials and conditions: Visible change, scale, photograph/assessment and direction
Conditions for verification: Link Visible change, scale, photograph/assessment and direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.
Requirement and applicability: Required
Application exceptions: Do not convert hairs/cm² into appearance scores, fullness percentages or perceived change.
Why this condition is needed: Production condition to record the actual scope of Visible change, scale, photograph/assessment and direction.
Referenced methods: 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

N13 · Is actual standardized-photograph or independent-assessment material available?

Required materials and conditions: Photographs/independent observation, consistent conditions, blinding and judgment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not assert that photographic assessment existed or did not exist, or provide photography/hair-care procedures.
Why this condition is needed: Production condition to record the actual scope of Photographs/independent observation, consistent conditions, blinding and judgment.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

N14 · What are the direct patient-perception, satisfaction and quality-of-life values?

Required materials and conditions: Distinguish patient perception, appearance/satisfaction and symptoms/quality of life
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not attribute positive density numbers to improved satisfaction or quality of life.
Why this condition is needed: Production condition to record the actual scope of Distinguish patient perception, appearance/satisfaction and symptoms/quality of life.
Referenced methods: 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

N15 · What are appearance-assessment timing and durability?

Required materials and conditions: Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not use day-90/day-180 instrumental signals to fill appearance improvement, long-term maintenance or recurrence prevention.
Why this condition is needed: Production condition to record the actual scope of Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up.
Referenced methods: 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

N16 · What separate measurement is the TrichoScan endpoint?

Required materials and conditions: Phototrichoscopy, change from baseline density and hairs/cm²
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not convert measured hair counts into total scalp hair count, thickness/appearance or clinical recovery.
Why this condition is needed: Production condition to record the actual scope of Phototrichoscopy, change from baseline density and hairs/cm².
Referenced methods: 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

N17 · What are the original day-180 density-change values?

Required materials and conditions: Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not subtract the numbers to create a new net effect or appearance increase, or treat ± as a CI.
Why this condition is needed: Production condition to record the actual scope of Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01.
Referenced methods: 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

N18 · What hierarchy applies to day-90 and hair-cycle-ratio results?

Required materials and conditions: Qualitative day-90 difference, secondary cycle ratio and separate endpoint
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not transfer cycle ratios or qualitative day-90 findings into direct visible-fullness values, effects or duration.
Why this condition is needed: Production condition to record the actual scope of Qualitative day-90 difference, secondary cycle ratio and separate endpoint.
Referenced methods: 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

N19 · Are direct between-group appearance effects and CIs provided?

Required materials and conditions: Actual appearance contrast, numerator/scale, intervals and adjustment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not calculate appearance effects, CIs or response rates from instrumental P values, ± or density changes.
Why this condition is needed: Production condition to record the actual scope of Actual appearance contrast, numerator/scale, intervals and adjustment.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N20 · What are clinically important instrumental/appearance thresholds?

Required materials and conditions: Importance of hairs/cm² and direct visible/perceived-change criteria
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not establish meaningful visible recovery solely from positive P values or hairs/cm² increase size.
Why this condition is needed: Production condition to record the actual scope of Importance of hairs/cm² and direct visible/perceived-change criteria.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

N21 · How do appearance-assessment denominators differ from 106 randomized participants?

Required materials and conditions: 53/53 allocation, valid appearance/responses and actual analysis by time point
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not copy 53/53 allocation as appearance-results n or add measurement areas/time points as people.
Why this condition is needed: Production condition to record the actual scope of 53/53 allocation, valid appearance/responses and actual analysis by time point.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N22 · What records describe missingness, attrition and analysis populations?

Required materials and conditions: Instrumental/appearance analysis populations, missingness/attrition and supporting analyses
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not change historical missing-data uncertainty into zero dropout, complete ITT or new defect counts/scores.
Why this condition is needed: Production condition to record the actual scope of Instrumental/appearance analysis populations, missingness/attrition and supporting analyses.
Referenced methods: 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.

N23 · What actual prospective plans apply to appearance/instrumental endpoints?

Required materials and conditions: Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not promote retrospective-registration outcomes to prospective registration or original prespecified-secondary wording to current plan verification.
Why this condition is needed: Production condition to record the actual scope of Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

N24 · What original records give registration, posting and completion dates?

Required materials and conditions: NCT07111312, posting 2025-08-08 and completion 2024-05-10
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not calculate elapsed time or change retrospective/original-date history into a registration lookup performed here.
Why this condition is needed: Production condition to record the actual scope of NCT07111312, posting 2025-08-08 and completion 2024-05-10.
Referenced methods: 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

N25 · What are the report identity and actual preserved-summary locations?

Required materials and conditions: SáezMoya2025·CT-OW-02·PMID41288927
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not infer DOI/PMCID from PMID or create additional slots/trials from other-product reports.
Why this condition is needed: Production condition to record the actual scope of Sáez Moya 2025, CT-OW-02 and PMID 41288927.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N26 · Are subquestions, time points and hair measures kept separate from independent replication?

Required materials and conditions: The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not add days 90/180, hair cycle/areas, parent/sibling sheets or report/material slots as independent trials/participants.
Why this condition is needed: Production condition to record the actual scope of The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance.
Referenced methods: 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

N27 · What were actual manufacturer roles and author relationships?

Required materials and conditions: Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not hide manufacturer roles or turn one manufacturer trial into current independence certification or a data-manipulation finding.
Why this condition is needed: Production condition to record the actual scope of Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N28 · Can this extend to other products, formulations, ingredients, populations or durability?

Required materials and conditions: Olistic Women finished product, selected population and other products/long-term outcomes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not write other-brand/ingredient or general hair-loss benefit/safety, consumption or treatment guidance.
Why this condition is needed: Production condition to record the actual scope of Olistic Women finished product, selected population and other products/long-term outcomes.
Referenced methods: 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

N29 · How are original dates, corrections, Korean/English texts, axes and history preserved?

Required materials and conditions: 2026-08-26, empty corrections/deliberation and original assessment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not fill absent/empty values or historical cross-checks with new scores/axes or completed review.
Why this condition is needed: Production condition to record the actual scope of 2026-08-26, empty corrections/deliberation and original assessment.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

N30 · What was actually read and what are external-material states?

Required materials and conditions: Complete preserved 2956 summary, selected original record and summary/external distinction
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not promote URLs, historical paper/registration wording or copies into full-text reading, successful access or link checks.
Why this condition is needed: Production condition to record the actual scope of Complete preserved 2956 summary, selected original record and summary/external distinction.
Referenced methods: 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

N31 · What is linked when new material or corrections become available?

Required materials and conditions: Condition version, originals, observations, reading and change event
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Original candidate pending/eligibility states are historical; do not revive active model/content/boundary-review waits.
Why this condition is needed: Production condition to record the actual scope of Condition version, originals, observations, reading and change event.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

H01 · Were minor adverse events actually collected?

Required materials and conditions: Original minor-AE noncollection, definitions/collection and relatedness
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not change minor-event noncollection into no events, good tolerability or access failure.
Why this condition is needed: Production condition to record the actual scope of Original minor-AE noncollection, definitions/collection and relatedness.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

H02 · What were actual safety-observation periods and exposure?

Required materials and conditions: Six-month trial exposure, harm-collection periods and post-discontinuation follow-up
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn six-month follow-up alone into comprehensive safety collection or long-term safety assurance.
Why this condition is needed: Production condition to record the actual scope of Six-month trial exposure, harm-collection periods and post-discontinuation follow-up.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

H03 · Are group-specific product/placebo harm comparisons available?

Required materials and conditions: Related/all, serious/minor, group-specific events and comparison
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not confirm zero serious events or safety equivalence from absent group-specific quantities.
Why this condition is needed: Production condition to record the actual scope of Related/all, serious/minor, group-specific events and comparison.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

H04 · How do safety denominators differ from allocation/analysis denominators?

Required materials and conditions: 53/53 allocation, actual exposure/safety collection and endpoint-specific n
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not copy 53/53 allocation as collection denominators for all harms or calculate incidence.
Why this condition is needed: Production condition to record the actual scope of 53/53 allocation, actual exposure/safety collection and endpoint-specific n.
Referenced methods: 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

H05 · What are multi-ingredient, baseline, concurrent-exposure and relatedness records?

Required materials and conditions: Finished product, individual ingredients, baseline/concurrent management and harm relatedness
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not invent unrecorded allergy/interaction cases as observed events or newly attribute product harm to an ingredient.
Why this condition is needed: Production condition to record the actual scope of Finished product, individual ingredients, baseline/concurrent management and harm relatedness.
Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed

H06 · Are noncollection, nonreporting, unread material and zero events distinguished?

Required materials and conditions: Original minor-AE noncollection, currently unread external material and other-harm states
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not change minor-AE noncollection or current nonreading into all events zero, absent papers or access failure.
Why this condition is needed: Production condition to record the actual scope of Original minor-AE noncollection, currently unread external material and other-harm states.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

H07 · Are manufacturer reports, time points and questions kept separate from duplicate totals?

Required materials and conditions: The same CT-OW-02, 106 participants and instrumental/appearance/harm family
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not add material slots, two subquestions, time points or areas as independent trials, participants or events.
Why this condition is needed: Production condition to record the actual scope of The same CT-OW-02, 106 participants and instrumental/appearance/harm family.
Referenced methods: 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

H08 · What long-term safety gaps concern other populations, periods and products?

Required materials and conditions: Premenopausal telogen effluvium, finished product, six months and other conditions
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn positive instrumental findings into long-term supplement safety or consumption/treatment guidance.
Why this condition is needed: Production condition to record the actual scope of Premenopausal telogen effluvium, finished product, six months and other conditions.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

H09 · Are instrumental signals, appearance gaps and Unknown safety retained together?

Required materials and conditions: Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps
Conditions for verification: 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.
Requirement and applicability: Supporting harm information
Application exceptions: Do not change instrumental positivity into appearance benefit or safety assurance, or appearance gaps into zero effect or treatment recommendations.
Why this condition is needed: Production condition to record the actual scope of Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

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.

Change history

2026-10-12 · Public page/material version 1.0

The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected original question and assessment record?

Current findings: The selected original question and assessment record concern visibly fuller hair. Parent and sibling TrichoScan hair-density questions concern a different endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: No new independent-claim certification, structural split or invented main assessment was created.
Required materials and conditions: Original visibly fuller hair wording, Korean/English texts and link
Materials to obtain first: Preserved selected assessment record and complete parent summary
Further research: If the question changes, retain original wording, the previous complete version and the change event.
Remaining uncertainty: Within the production scope of the preserved summary. No new independent-claim certification, structural split or invented main assessment was created.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Original visibly fuller hair wording, Korean/English texts and link.
Application exceptions: Do not count instrumental and appearance questions in one report as new independent trials or participants.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

Related sources R01

N02 · How do the subclaim ? and parent C50, axes and history differ?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Selected-row score, status and axes are null; do not fill them with parent score or grade.
Required materials and conditions: Subclaim grade/note, absent score/status/axes and actual parent values
Materials to obtain first: Original subclaim record and parent grade/score/axes and assessment history
Further research: Distinguish actual evidence-update events from preservation of original values.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Subclaim grade/note, absent score/status/axes and actual parent values.
Application exceptions: Do not transfer parent measured-density C50 or historical cross-checks into a new appearance assessment, score or completed content review.
Referenced methods: 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

Related sources R01

N03 · Which selected population of women entered the finished-product trial?

Current findings: CT-OW-02 was a multicenter trial in 106 premenopausal women diagnosed with telogen effluvium.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Age, diagnostic criteria, acute/chronic course, baseline hair loss, nutritional status, recruitment/exclusion and representativeness details are unverified.
Required materials and conditions: Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection
Materials to obtain first: Original diagnostic/selection criteria, baseline characteristics and recruitment flow
Further research: Distinguish other-population material by actual diagnosis, menopausal status, baseline characteristics and selection.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection.
Application exceptions: Do not generalize to all female hair loss, men, postmenopausal women, other hair-loss types or deficiency populations.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources R01

N04 · What material describes baseline appearance, hair loss and diagnosis?

Current findings: The original summary records telogen-effluvium diagnosis and TrichoScan results without providing direct selected appearance-assessment material.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Diagnostic methods, differential assessment, baseline photographs/appearance, patient burden, duration and mixed diagnoses are unverified.
Required materials and conditions: Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment
Materials to obtain first: Original diagnosis, baseline appearance/symptoms and assessment criteria
Further research: Record actual baseline diagnosis and starting appearance when appearance-change material becomes available.
Remaining uncertainty: Within the production scope of the preserved summary. Diagnostic methods, differential assessment, baseline photographs/appearance, patient burden, duration and mixed diagnoses are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment.
Application exceptions: Do not create clinical hair-loss severity, baseline perception or differential diagnoses from TrichoScan numbers alone.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation

Related sources R01

N05 · What are the finished product and ingredient scope?

Current findings: The original product is Olistic Women drinkable multi-ingredient nutraceutical. The manufacturer is recorded as supplying trial product and placebo.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Ingredient identities/quantities, batch, standardization, packaging/form and individual-ingredient effects are unverified.
Required materials and conditions: Olistic Women drinkable multi-ingredient finished product, formulation and composition
Materials to obtain first: Trial finished-product composition, batch, formulation and supply records
Further research: If material is provided, distinguish the finished product from individual ingredients and other formulations.
Remaining uncertainty: Within the production scope of the preserved summary. Ingredient identities/quantities, batch, standardization, packaging/form and individual-ingredient effects are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Olistic Women drinkable multi-ingredient finished product, formulation and composition.
Application exceptions: Do not fill in unrecorded biotin/vitamins/botanicals or attribute an effect to an individual ingredient.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

Related sources R01

N06 · What were the original trial exposure and actual implementation?

Current findings: Original product information describes a finished-product trial of one 25-mL vial daily for six months. This preserves trial exposure.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual adherence, cumulative exposure, stopping/changes, ingredients per vial and other-dose comparisons are unverified.
Required materials and conditions: One 25-mL vial daily for six months and actual adherence/exposure
Materials to obtain first: Actual product exposure, adherence and discontinuation records
Further research: Distinguish nominal exposure from actual implementation in subsequent material.
Remaining uncertainty: Within the production scope of the preserved summary. Actual adherence, cumulative exposure, stopping/changes, ingredients per vial and other-dose comparisons are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of One 25-mL vial daily for six months and actual adherence/exposure.
Application exceptions: Do not write consumption, product-selection, dosing, dose-conversion or treatment instructions.
Referenced methods: 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

Related sources R01

N07 · What were the placebo and common conditions?

Current findings: CT-OW-02 was placebo-controlled; the company is recorded as supplying product and placebo.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Placebo ingredients/calories, appearance/taste matching, distribution/adherence and differences in common management are unverified.
Required materials and conditions: Manufacturer-supplied placebo, actual composition/appearance and comparison direction
Materials to obtain first: Placebo composition, common conditions and actual exposure/blinding material
Further research: Distinguish the actual product/placebo contrast from comparisons with other ingredients.
Remaining uncertainty: Within the production scope of the preserved summary. Placebo ingredients/calories, appearance/taste matching, distribution/adherence and differences in common management are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Manufacturer-supplied placebo, actual composition/appearance and comparison direction.
Application exceptions: Do not change placebo into no treatment or an unrecorded active comparator.
Referenced methods: 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

Related sources R01

N08 · What were randomization and actual analysis scopes?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual completion and appearance/instrumental analysis denominators, original sequence/concealment methods and flow remain unread.
Required materials and conditions: 106 participants, 53/53 allocation, sequence/concealment and completion/analysis
Materials to obtain first: Allocation methods, group flow and actual endpoint-specific analysis n
Further research: If original material is provided, distinguish allocation from actual completion/analysis and measurement level.
Remaining uncertainty: Within the production scope of the preserved summary. Actual completion and appearance/instrumental analysis denominators, original sequence/concealment methods and flow remain unread.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of 106 participants, 53/53 allocation, sequence/concealment and completion/analysis.
Application exceptions: Do not copy 53/53 as verified analysis denominators for every time point/appearance endpoint or assign new methodological-defect scores.
Referenced methods: 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

Related sources R01

N09 · What were double-blinding and appearance-assessor conditions?

Current findings: The original design was a multicenter double-blind placebo-controlled randomized trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Who was blinded, product distinguishability, instrumental/appearance/photograph assessors and unblinding timing are unverified.
Required materials and conditions: Participants/measurers, photograph/appearance reading and maintained blinding
Materials to obtain first: Blinding, reading, photograph/appearance methods and actual implementation
Further research: Record patient/independent-assessor blinding and consistent assessment conditions in appearance material.
Remaining uncertainty: Within the production scope of the preserved summary. Who was blinded, product distinguishability, instrumental/appearance/photograph assessors and unblinding timing are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Participants/measurers, photograph/appearance reading and maintained blinding.
Application exceptions: Do not confirm separate appearance assessment or blinding of every assessor from the design label alone.
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

Related sources R01

N10 · What were concurrent hair care, treatment and natural course?

Current findings: The summary records instrumental results for a particular finished product and placebo.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Concurrent treatment/nutrition/hair care, cosmetic/styling changes, lifestyle, natural course and group differences are unverified.
Required materials and conditions: Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery
Materials to obtain first: Original common/restricted conditions, concurrent exposure and actual implementation
Further research: Distinguish finished-product exposure from concurrent management/natural course in later appearance material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery.
Application exceptions: Do not write new treatment, washing/cosmetic or hair-care methods or calculate natural recovery.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

Related sources R01

N11 · What is the direct endpoint for visibly fuller hair?

Current findings: The original subclaim note says appearance was not the primary endpoint. The parent distinguishes TrichoScan counts from patient perception.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Appearance definition, observer/patient judgment, actual assessment and scale/categories are unverified.
Required materials and conditions: Visible fullness definition, observer and patient perception
Materials to obtain first: Direct appearance/patient-perception definitions, results and methods
Further research: Report actual appearance assessor, definition, timing and denominator separately from instrumental counts.
Remaining uncertainty: Within the production scope of the preserved summary. Appearance definition, observer/patient judgment, actual assessment and scale/categories are unverified.
Conditions for verification: Link Visible fullness definition, observer and patient perception to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.
Why this condition is needed: Production condition to record the actual scope of Visible fullness definition, observer and patient perception.
Application exceptions: Do not present density change or the question wording as observed appearance improvement.
Referenced methods: 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

Related sources R01

N12 · What are the appearance scale and units of visible change?

Current findings: The summary provides no direct appearance-change score, unit or response category.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Photographic assessment/scale, overall appearance, observer agreement, assessment conditions and validity criteria are unverified.
Required materials and conditions: Visible change, scale, photograph/assessment and direction
Materials to obtain first: Direct appearance scale, definitions, measurement/reading methods and results
Further research: State scale direction, observer and change definition in appearance material.
Remaining uncertainty: Within the production scope of the preserved summary. Photographic assessment/scale, overall appearance, observer agreement, assessment conditions and validity criteria are unverified.
Conditions for verification: Link Visible change, scale, photograph/assessment and direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.
Why this condition is needed: Production condition to record the actual scope of Visible change, scale, photograph/assessment and direction.
Application exceptions: Do not convert hairs/cm² into appearance scores, fullness percentages or perceived change.
Referenced methods: 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

Related sources R01

N13 · Is actual standardized-photograph or independent-assessment material available?

Current findings: The original summary only provides the boundary that appearance assessment was not the primary endpoint.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Whether photographs were taken/read, lighting/angle/styling conditions, independent assessment, blinding, agreement and results are unverified.
Required materials and conditions: Photographs/independent observation, consistent conditions, blinding and judgment
Materials to obtain first: Original methods and actual direct photograph-assessment results
Further research: State assessment conditions, independence and judgment level in later appearance material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Photographs/independent observation, consistent conditions, blinding and judgment.
Application exceptions: Do not assert that photographic assessment existed or did not exist, or provide photography/hair-care procedures.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources R01

N14 · What are the direct patient-perception, satisfaction and quality-of-life values?

Current findings: The original reader answer distinguishes perceived visible fullness from instrumental counts.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Patient-reported fullness, satisfaction, burden/quality of life, response scales, denominators and effects are unverified.
Required materials and conditions: Distinguish patient perception, appearance/satisfaction and symptoms/quality of life
Materials to obtain first: Patient-centered outcomes, scales, response/analysis n and original results tables
Further research: Record instrumental counts, appearance observation, satisfaction and quality of life as separate endpoints.
Remaining uncertainty: Within the production scope of the preserved summary. Patient-reported fullness, satisfaction, burden/quality of life, response scales, denominators and effects are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Distinguish patient perception, appearance/satisfaction and symptoms/quality of life.
Application exceptions: Do not attribute positive density numbers to improved satisfaction or quality of life.
Referenced methods: 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

Related sources R01

N15 · What are appearance-assessment timing and durability?

Current findings: The original trial describes six months and day-90/day-180 instrumental results. Actual selected appearance measurement/follow-up is not separately provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Appearance-assessment timing, persistence, follow-up after stopping and long-term patient perception are unverified.
Required materials and conditions: Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up
Materials to obtain first: Direct appearance assessment by time point and post-discontinuation follow-up
Further research: Distinguish on-treatment measurement from post-discontinuation persistence by actual timing and denominator.
Remaining uncertainty: Within the production scope of the preserved summary. Appearance-assessment timing, persistence, follow-up after stopping and long-term patient perception are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up.
Application exceptions: Do not use day-90/day-180 instrumental signals to fill appearance improvement, long-term maintenance or recurrence prevention.
Referenced methods: 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

Related sources R01

N16 · What separate measurement is the TrichoScan endpoint?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Device/measurement site/area, image/hair-length conditions, repetition/reading and baseline values are unverified.
Required materials and conditions: Phototrichoscopy, change from baseline density and hairs/cm²
Materials to obtain first: Instrumental methods, area/site and original density-results tables
Further research: Record hair counts, sites/areas and separate appearance/perception definitions together.
Remaining uncertainty: Within the production scope of the preserved summary. Device/measurement site/area, image/hair-length conditions, repetition/reading and baseline values are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Phototrichoscopy, change from baseline density and hairs/cm².
Application exceptions: Do not convert measured hair counts into total scalp hair count, thickness/appearance or clinical recovery.
Referenced methods: 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

Related sources R01

N17 · What are the original day-180 density-change values?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: The statistical meaning of ±, time-specific analysis n, baseline/final values and between-group effects/intervals are unverified.
Required materials and conditions: Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01
Materials to obtain first: Original day-180 instrumental tables, variability/denominators and analysis methods
Further research: Link changes, group contrasts, variability and actual n separately in original results tables.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01.
Application exceptions: Do not subtract the numbers to create a new net effect or appearance increase, or treat ± as a CI.
Referenced methods: 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

Related sources R01

N18 · What hierarchy applies to day-90 and hair-cycle-ratio results?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Day-90 quantities, actual ratio timing/denominators, hierarchy/plan dates and intervals/adjustment are unverified.
Required materials and conditions: Qualitative day-90 difference, secondary cycle ratio and separate endpoint
Materials to obtain first: Original density/cycle-ratio tables by time point and plans/hierarchy
Further research: Distinguish density, cycle ratio and appearance endpoints, timing and hierarchy.
Remaining uncertainty: Within the production scope of the preserved summary. Day-90 quantities, actual ratio timing/denominators, hierarchy/plan dates and intervals/adjustment are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Qualitative day-90 difference, secondary cycle ratio and separate endpoint.
Application exceptions: Do not transfer cycle ratios or qualitative day-90 findings into direct visible-fullness values, effects or duration.
Referenced methods: 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

Related sources R01

N19 · Are direct between-group appearance effects and CIs provided?

Current findings: Density P values and absent CIs in the summary concern instrumental context. Direct selected appearance contrasts/CIs are not provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Appearance-score/response contrasts, baseline adjustment, models, variability and confidence intervals are unverified.
Required materials and conditions: Actual appearance contrast, numerator/scale, intervals and adjustment
Materials to obtain first: Direct appearance results, denominators, variability and models/intervals
Further research: If original appearance material is provided, link its measure, unit, population and estimated interval.
Remaining uncertainty: Within the production scope of the preserved summary. Appearance-score/response contrasts, baseline adjustment, models, variability and confidence intervals are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Actual appearance contrast, numerator/scale, intervals and adjustment.
Application exceptions: Do not calculate appearance effects, CIs or response rates from instrumental P values, ± or density changes.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

Related sources R01

N20 · What are clinically important instrumental/appearance thresholds?

Current findings: The original counterview says 95% CIs and a clinically important minimum hairs/cm² threshold were not reported. No separate direct appearance threshold is provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Validation connecting instrumental differences to visible/perceived change, minimum appearance importance and original prespecified criteria are unverified.
Required materials and conditions: Importance of hairs/cm² and direct visible/perceived-change criteria
Materials to obtain first: Validation linking instrumental and appearance/perception outcomes and importance criteria
Further research: Distinguish measure, population and prespecified/post-hoc importance criteria.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Importance of hairs/cm² and direct visible/perceived-change criteria.
Application exceptions: Do not establish meaningful visible recovery solely from positive P values or hairs/cm² increase size.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

Related sources R01

N21 · How do appearance-assessment denominators differ from 106 randomized participants?

Current findings: The summary records 106 randomized participants, 53/53. Direct appearance-assessment/response denominators are not provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Instrumental/appearance completion, valid responses, analysis n, areas/repeated measurements and group correspondence are unverified.
Required materials and conditions: 53/53 allocation, valid appearance/responses and actual analysis by time point
Materials to obtain first: Group flow, actual endpoint/time-specific denominators and response criteria
Further research: Distinguish people, measurement areas, time points and instrumental/appearance denominators.
Remaining uncertainty: Within the production scope of the preserved summary. Instrumental/appearance completion, valid responses, analysis n, areas/repeated measurements and group correspondence are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of 53/53 allocation, valid appearance/responses and actual analysis by time point.
Application exceptions: Do not copy 53/53 allocation as appearance-results n or add measurement areas/time points as people.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources R01

N22 · What records describe missingness, attrition and analysis populations?

Current findings: The original research explanation says missing-data handling details were not confirmed in the public paper. External papers/tables remain unread here.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Completion/dropout counts/reasons, ITT/PP, imputation/sensitivity, appearance-response selection and actual analysis are unverified.
Required materials and conditions: Instrumental/appearance analysis populations, missingness/attrition and supporting analyses
Materials to obtain first: Original flow, analysis populations, missingness/attrition and sensitivity material
Further research: Distinguish allocation, measurement, completion, response/analysis and missingness assumptions.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Instrumental/appearance analysis populations, missingness/attrition and supporting analyses.
Application exceptions: Do not change historical missing-data uncertainty into zero dropout, complete ITT or new defect counts/scores.
Referenced methods: 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.

Related sources R01

N23 · What actual prospective plans apply to appearance/instrumental endpoints?

Current findings: The original primary endpoint was TrichoScan density rather than appearance. The cycle ratio is described as prespecified secondary in the original summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Appearance-endpoint existence/hierarchy, original protocol/SAP dates, multiplicity, selective reporting and actual prespecification are unverified.
Required materials and conditions: Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration
Materials to obtain first: Registration history and protocol/SAP outcomes, hierarchy and analysis
Further research: If plans are provided, distinguish actual prospective/retrospective timing, endpoints and hierarchy.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration.
Application exceptions: Do not promote retrospective-registration outcomes to prospective registration or original prespecified-secondary wording to current plan verification.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

Related sources R01

N24 · What original records give registration, posting and completion dates?

Current findings: The summary records NCT07111312 first posting 2025-08-08 and primary completion 2024-05-10, after-trial registration that cannot support prospective registration.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Current registration text, revision history, original plans and individual-endpoint/completion material are unread.
Required materials and conditions: NCT07111312, posting 2025-08-08 and completion 2024-05-10
Materials to obtain first: Original registration/history, protocol/SAP and actual trial timeline
Further research: If material is provided, distinguish original dates, current reading and condition/assessment-change events.
Remaining uncertainty: Within the production scope of the preserved summary. Current registration text, revision history, original plans and individual-endpoint/completion material are unread.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of NCT07111312, posting 2025-08-08 and completion 2024-05-10.
Application exceptions: Do not calculate elapsed time or change retrospective/original-date history into a registration lookup performed here.
Referenced methods: 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

Related sources R01

N25 · What are the report identity and actual preserved-summary locations?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: DOI, PMCID, current external bibliography/full text and original appearance-results locations are not provided.
Required materials and conditions: SáezMoya2025·CT-OW-02·PMID41288927
Materials to obtain first: Original bibliography, full text and registration/product/population links
Further research: When bibliography is supplemented, preserve original wording, report identity and change events.
Remaining uncertainty: Within the production scope of the preserved summary. DOI, PMCID, current external bibliography/full text and original appearance-results locations are not provided.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Sáez Moya 2025, CT-OW-02 and PMID 41288927.
Application exceptions: Do not infer DOI/PMCID from PMID or create additional slots/trials from other-product reports.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources R01

N26 · Are subquestions, time points and hair measures kept separate from independent replication?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Unique trial/participant totals and independent replication were not newly searched, summed or certified.
Required materials and conditions: The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance
Materials to obtain first: Trial-report-person-time-area-endpoint links
Further research: Distinguish the same population/re-reporting from different recruitment/trials in additional reports.
Remaining uncertainty: Within the production scope of the preserved summary. Unique trial/participant totals and independent replication were not newly searched, summed or certified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance.
Application exceptions: Do not add days 90/180, hair cycle/areas, parent/sibling sheets or report/material slots as independent trials/participants.
Referenced methods: 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

Related sources R01

N27 · What were actual manufacturer roles and author relationships?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Original disclosures of analysis/writing/publication decisions, data access, other authors/relationships and current contracts are unread.
Required materials and conditions: Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author
Materials to obtain first: Original support, product/placebo, author disclosures and analysis/publication roles
Further research: If disclosures are provided, distinguish product supply, funding, sponsor, employee author and analysis/publication.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author.
Application exceptions: Do not hide manufacturer roles or turn one manufacturer trial into current independence certification or a data-manipulation finding.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources R01

N28 · Can this extend to other products, formulations, ingredients, populations or durability?

Current findings: The summary says results cannot extend to Viviscal, Nutrafol or the supplement class and do not establish visible fullness, durability or other-formulation effects.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Other products/ingredients, populations, doses/durations and direct appearance/long-term/post-discontinuation outcomes are unverified within this reading scope.
Required materials and conditions: Olistic Women finished product, selected population and other products/long-term outcomes
Materials to obtain first: Direct comparisons and appearance results for actual other formulations/populations/durations
Further research: Link actual finished product, population, exposure and endpoints separately in new material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Olistic Women finished product, selected population and other products/long-term outcomes.
Application exceptions: Do not write other-brand/ingredient or general hair-loss benefit/safety, consumption or treatment guidance.
Referenced methods: 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

Related sources R01

N29 · How are original dates, corrections, Korean/English texts, axes and history preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Classification and primary_failed_secondary_positive keys are absent. Empty corrections are not a current external correction/retraction check.
Required materials and conditions: 2026-08-26, empty corrections/deliberation and original assessment
Materials to obtain first: Complete previous summary and actual change/correction events
Further research: Distinguish complete pre-change text, events, versions and separate application when changes occur.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of 2026-08-26, empty corrections/deliberation and original assessment.
Application exceptions: Do not fill absent/empty values or historical cross-checks with new scores/axes or completed review.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources R01

N30 · What was actually read and what are external-material states?

Current findings: The selected original record and complete preserved 2956 summary were read for production. Distinguish one report summary from unread external/required-material slots.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: External abstracts, full texts, registration, plans, original results/harms and disclosures were not accessed or acquired.
Required materials and conditions: Complete preserved 2956 summary, selected original record and summary/external distinction
Materials to obtain first: User-provided originals and actual acquisition/reading records
Further research: Distinguish material type, publication/access, acquisition and actual reading scope/dates in new material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Complete preserved 2956 summary, selected original record and summary/external distinction.
Application exceptions: Do not promote URLs, historical paper/registration wording or copies into full-text reading, successful access or link checks.
Referenced methods: 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

Related sources R01

N31 · What is linked when new material or corrections become available?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: No new clinical search, calculation, evidence/effect, reassessment, independence certification or model/self content review was performed.
Required materials and conditions: Condition version, originals, observations, reading and change event
Materials to obtain first: User-provided direct appearance/patient assessments, denominators, plans, harms/corrections
Further research: Separate actual additions/changes into complete prior versions, events, condition versions/freezing, separate application and current handoff.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Condition version, originals, observations, reading and change event.
Application exceptions: Original candidate pending/eligibility states are historical; do not revive active model/content/boundary-review waits.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources R01

H01 · Were minor adverse events actually collected?

Current findings: The summary preserves the authors' explicit statement that minor adverse events were not collected at all and that general tolerability therefore cannot be assessed.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual minor-event types/frequencies, full collection definitions and relatedness are unverified. The original external wording was not read here.
Required materials and conditions: Original minor-AE noncollection, definitions/collection and relatedness
Materials to obtain first: Original harm-collection plans, definitions, full results and disclosed wording
Further research: Distinguish minor/serious events by actual collection scope and relatedness in subsequent material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Original minor-AE noncollection, definitions/collection and relatedness.
Application exceptions: Do not change minor-event noncollection into no events, good tolerability or access failure.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01

H02 · What were actual safety-observation periods and exposure?

Current findings: Original product exposure was six months; minor-event noncollection prevents general tolerability assessment.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Serious/other harm-collection periods, collection by visit, stopping/follow-up courses and actual exposure are unverified.
Required materials and conditions: Six-month trial exposure, harm-collection periods and post-discontinuation follow-up
Materials to obtain first: Periods/exposure, collection schedules and stopping/follow-up harm material
Further research: Report the original trial period and actual collection/follow-up periods separately.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Six-month trial exposure, harm-collection periods and post-discontinuation follow-up.
Application exceptions: Do not turn six-month follow-up alone into comprehensive safety collection or long-term safety assurance.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

Related sources R01

H03 · Are group-specific product/placebo harm comparisons available?

Current findings: The summary records minor-event noncollection and safety gaps without providing quantitative group-specific harms.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual product/placebo events, severity/relatedness, intervals and comparable collection are unverified.
Required materials and conditions: Related/all, serious/minor, group-specific events and comparison
Materials to obtain first: Group-specific all/serious harms, relatedness and collection/denominator tables
Further research: Link group definitions, collection, periods and effects/intervals separately in direct harm material.
Remaining uncertainty: Within the production scope of the preserved summary. Actual product/placebo events, severity/relatedness, intervals and comparable collection are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Related/all, serious/minor, group-specific events and comparison.
Application exceptions: Do not confirm zero serious events or safety equivalence from absent group-specific quantities.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

Related sources R01

H04 · How do safety denominators differ from allocation/analysis denominators?

Current findings: The 106 participants, 53/53, in the summary are randomized counts. Minor events were not collected.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual safety exposure/completion, collection/analysis n, group exclusion/stopping and serious-event denominators are unverified.
Required materials and conditions: 53/53 allocation, actual exposure/safety collection and endpoint-specific n
Materials to obtain first: Exposure, stopping, safety populations/denominators and original flow
Further research: Distinguish allocation, exposure, collection and completion/analysis denominators in harm material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of 53/53 allocation, actual exposure/safety collection and endpoint-specific n.
Application exceptions: Do not copy 53/53 allocation as collection denominators for all harms or calculate incidence.
Referenced methods: 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

Related sources R01

H05 · What are multi-ingredient, baseline, concurrent-exposure and relatedness records?

Current findings: Original exposure concerned a particular drinkable multi-ingredient finished product. Minor harms were outside the original collection scope.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Ingredient quantities, concurrent supplements/medication, baseline disease, actual cases, alternative factors and relatedness judgments are unverified.
Required materials and conditions: Finished product, individual ingredients, baseline/concurrent management and harm relatedness
Materials to obtain first: Product composition, concurrent exposure, actual cases and relatedness review
Further research: Distinguish finished product, individual ingredients and baseline/concurrent factors in direct harm material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Finished product, individual ingredients, baseline/concurrent management and harm relatedness.
Application exceptions: Do not invent unrecorded allergy/interaction cases as observed events or newly attribute product harm to an ingredient.
Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed

Related sources R01

H06 · Are noncollection, nonreporting, unread material and zero events distinguished?

Current findings: The original record describes minor-event noncollection; external full texts/tables are currently unread. These remain distinct states.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Actual noncollection/nonreporting/missingness/zero distinctions for other harms and serious-event originals are unverified.
Required materials and conditions: Original minor-AE noncollection, currently unread external material and other-harm states
Materials to obtain first: Full safety collection/results, omission reasons and reading records
Further research: Distinguish collection scope, nonreporting/missingness and actual zero only within provided material.
Remaining uncertainty: Within the production scope of the preserved summary. Actual noncollection/nonreporting/missingness/zero distinctions for other harms and serious-event originals are unverified.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Original minor-AE noncollection, currently unread external material and other-harm states.
Application exceptions: Do not change minor-AE noncollection or current nonreading into all events zero, absent papers or access failure.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

Related sources R01

H07 · Are manufacturer reports, time points and questions kept separate from duplicate totals?

Current findings: Days 90/180, density/cycle ratio and appearance questions in one report remain one trial context. Direct appearance effects/harms are separately unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: New independent harm reports, duplicated events/people and other recruitment populations were not verified here.
Required materials and conditions: The same CT-OW-02, 106 participants and instrumental/appearance/harm family
Materials to obtain first: Trial-person-time-endpoint-event-report links
Further research: Distinguish re-reporting of the same events from new trials/events in additional harm material.
Remaining uncertainty: Within the production scope of the preserved summary. New independent harm reports, duplicated events/people and other recruitment populations were not verified here.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of The same CT-OW-02, 106 participants and instrumental/appearance/harm family.
Application exceptions: Do not add material slots, two subquestions, time points or areas as independent trials, participants or events.
Referenced methods: 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

Related sources R01

H08 · What long-term safety gaps concern other populations, periods and products?

Current findings: Parent safety is Unknown and the trial concerns a particular finished product and selected population.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Longer/different exposures, other products/ingredients, postmenopausal/other populations and disease/medication-specific direct harms are unverified in this scope.
Required materials and conditions: Premenopausal telogen effluvium, finished product, six months and other conditions
Materials to obtain first: Direct harms by population/product/period and long-term collection
Further research: State actual population, finished product/exposure, period and collection level in new harm material.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Premenopausal telogen effluvium, finished product, six months and other conditions.
Application exceptions: Do not turn positive instrumental findings into long-term supplement safety or consumption/treatment guidance.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01

H09 · Are instrumental signals, appearance gaps and Unknown safety retained together?

Current findings: Distinguish positive parent instrumental density from selected appearance ? while retaining minor-event noncollection and Unknown safety.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: No new benefit-harm synthesis, treatment/product selection or independence/causal certification was performed.
Required materials and conditions: Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps
Materials to obtain first: Direct appearance/patient results, harms and original follow-up material
Further research: Link each instrumental, appearance and harm endpoint, original location and change event separately in additional material.
Remaining uncertainty: Within the production scope of the preserved summary. No new benefit-harm synthesis, treatment/product selection or independence/causal certification was performed.
Conditions for verification: 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.
Why this condition is needed: Production condition to record the actual scope of Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps.
Application exceptions: Do not change instrumental positivity into appearance benefit or safety assurance, or appearance gaps into zero effect or treatment recommendations.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

Related sources R01