# Low-molecular-weight collagen peptide · WOMAC pain in early knee osteoarthritis — Evidence Check

Verdict 2965 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Early knee osteoarthritis trial in adults with Kellgren–Lawrence grade 1–2: 80 randomized, 40/40, distinguished from primary efficacy PP60/80, exclusion of 20/80 (25%) and safety population of 80. PP KL imbalance P=.037 and detailed baseline/recruitment, group denominators, missingness/deviations remain original accounts or unverified.
- Ingredient, formulation and route: The specific research product was low-molecular-weight collagen peptide, 3 g daily. Detailed molecular weight, source/composition, batches and actual exposure are unverified. This is not transferred to undenatured type II, ordinary hydrolyzed type I/III or all oral collagen; no new intake instructions, product recommendations or treatment methods are created.
- Dose: Original 3 g daily for 180 days is retained. PP inclusion required at least 80% adherence and no major deviation, distinct from actual individual adherence, changes and discontinuation. No conversion/implementation guidance for other doses, durations or long-term exposure is created.
- Comparator: Double-blind randomized trial versus placebo manufactured by NEWTREE. Allocation generation/concealment, role-specific masking, placebo ingredients/matching, accompanying pain management and actual implementation are unverified. Company nonparticipation is a paper declaration, not current confirmation of independence.
- Measured outcome: Selected prespecified primary endpoint: baseline-to-day-180 WOMAC pain change. Original PP60 changes of -1.90±4.14 versus +0.61±3.97 with placebo and approximate between-group -2.51 points/P=.006 are retained. Group-specific PP observed denominators, meaning of ±, scale range/units, original model/CI are unverified or originally unreported. The 10-point WOMAC total sample-size assumption and post hoc SMD 0.46/external AAOS 0.39 are separate planning/interpretive context, not a prespecified pain-success threshold. VAS P=.299 is a different result.
- Duration: The 180-day study and prespecified WOMAC change timing are retained. Actual individual visit windows, repeated/intermediate results, completed follow-up/exposure and long-term outcomes are unverified. Exact VAS timing is not filled from WOMAC timing.
- Questions outside this scope: Mixing WOMAC pain, WOMAC total and VAS scales, timing, estimands, denominators or hierarchy; Calculating new effects, CIs, final values or response rates from original ± values, P values or sample size, or relabeling original approximate -2.51/SMD as a current calculation; Using the same-direction ITT account to fill quantitative effects, significance or confirmed CI; Reusing PP60/80, exclusion of 20/80 (25%), randomized 40/40 or safety population of 80 as the same confirmed denominator for the selected outcome; Turning the 10-point WOMAC total sample-size assumption or post hoc SMD 0.46/external AAOS 0.39 into a prespecified pain/VAS success threshold; Extending positive WOMAC results to all pain scales/collagen, or converting nonsignificant VAS into exact zero effect, equivalence or certified exclusion of all important benefit; Totaling the same report/KCT, participants/groups, scales, time points or sibling sheets as new independent trials/participants; Turning product/placebo manufacture, support, company/subsidiary affiliations or nonparticipation declarations into new confirmation of independence or all detailed disclosures; Assigning parent scores/axes or historical cross-checks to subclaim scores, current review or original-material reading; New calculations, hypothetical values, effects/CIs, grades, independence certification or implementation guidance for collagen/product intake or pain/knee treatment

## Checklist items

### N01 · Selected question and original subclaim values

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original selected Reduced WOMAC pain subclaim, grade C and note are retained. Parent C50 and original axes concern the parent verdict.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Subclaim score, status and axes are absent; parent values are not assigned to the subclaim. Existing-content review remains incomplete.
- Reason for missing information: Subclaim score, status and axes are absent; parent values are not assigned to the subclaim.
- Required materials and conditions: Selected question grade/note, parent context and presence of score/status/axes
- Materials to obtain first: Materials distinguishing the selected subclaim from the parent verdict
- Further research: Proposed updating research linking original-question scope to additional materials; no new search, calculation or trial was performed.
- Conditions for verification: Selected question grade/note, parent context and presence of score/status/axes: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing selected question grade/note, parent context and presence of score/status/axes to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N02 · Early knee osteoarthritis population

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original population was 80 adults with Kellgren–Lawrence grade 1–2 early knee osteoarthritis.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Detailed eligibility, age/symptoms, baseline pain, comorbidities and group-specific characteristics are unverified. Existing-content review remains incomplete.
- Reason for missing information: Detailed eligibility, age/symptoms, baseline pain, comorbidities and group-specific characteristics are unverified.
- Required materials and conditions: Actual disease stage, recruitment criteria and baseline characteristics
- Materials to obtain first: Recruitment/eligibility, baseline characteristics and group-specific population materials
- Further research: Proposed follow-up research on applicability and heterogeneity within the same population scope; no new search, calculation or trial was performed.
- Conditions for verification: Actual disease stage, recruitment criteria and baseline characteristics: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing actual disease stage, recruitment criteria and baseline characteristics to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP
- Related sources: S01

### N03 · Specific low-molecular-weight peptide

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The specific tested low-molecular-weight collagen peptide at 3 g daily is retained; it does not become an effect of all oral collagen or other compositions.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Molecular-weight distribution, source/manufacturing, detailed composition, batches and actual individual exposure are unverified. Existing-content review remains incomplete.
- Reason for missing information: Molecular-weight distribution, source/manufacturing, detailed composition, batches and actual individual exposure are unverified.
- Required materials and conditions: Identity, composition and exposure of the tested preparation
- Materials to obtain first: Original product-identity, composition, batch and exposure materials
- Further research: Proposed follow-up research distinguishing formulation differences and result attribution; no new search, calculation or trial was performed.
- Conditions for verification: Identity, composition and exposure of the tested preparation: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing identity, composition and exposure of the tested preparation to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: S01

### N04 · Placebo, manufacturing and control conditions

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original double-blind placebo-controlled design and account that NEWTREE manufactured product and placebo are retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Placebo ingredients, sensory matching, co-exposure and equality of actual conditions between groups are unverified. Existing-content review remains incomplete.
- Reason for missing information: Placebo ingredients, sensory matching, co-exposure and equality of actual conditions between groups are unverified.
- Required materials and conditions: Actual placebo identity, matching and accompanying conditions
- Materials to obtain first: Placebo identity, sensory matching and group-specific co-exposure materials
- Further research: Proposed follow-up research on control conditions and measurement bias; no new search, calculation or trial was performed.
- Conditions for verification: Actual placebo identity, matching and accompanying conditions: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing actual placebo identity, matching and accompanying conditions to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; CHAMGAP-specific independence/attribution conditions. Official-method sections used in this pilot do not certify all these detailed items.
- Related sources: S01

### N05 · Research exposure: 3 g daily for 180 days

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original research condition was 3 g daily for 180 days; no new intake instructions, product recommendations or treatment methods are provided.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Individual exposure, adherence measurement, discontinuation/changes and results for other durations/doses are unverified. Existing-content review remains incomplete.
- Reason for missing information: Individual exposure, adherence measurement, discontinuation/changes and results for other durations/doses are unverified.
- Required materials and conditions: Original dose/duration and actual exposure/discontinuation
- Materials to obtain first: Research exposure, adherence, discontinuation and change records
- Further research: Proposed follow-up research distinguishing dose/duration-specific applicability; no new search, calculation or trial was performed.
- Conditions for verification: Original dose/duration and actual exposure/discontinuation: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing original dose/duration and actual exposure/discontinuation to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: S01

### N06 · 80 randomized; 40/40

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original allocation denominators of 80 participants randomized, 40 per group, are retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original allocation generation/concealment, stratification, responsible roles and implementation remain unread. The two groups are not separate trials. Existing-content review remains incomplete.
- Reason for missing information: Original allocation generation/concealment, stratification, responsible roles and implementation remain unread. The two groups are not separate trials.
- Required materials and conditions: Allocation unit, generation/concealment and group denominators
- Materials to obtain first: Allocation procedures, access permissions and analysis-population flow materials
- Further research: Proposed follow-up research on allocation procedures and actual populations; no new search, calculation or trial was performed.
- Conditions for verification: Allocation unit, generation/concealment and group denominators: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing allocation unit, generation/concealment and group denominators to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.
- Related sources: S01

### N07 · Double blinding and measurement roles

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original double-blind design is retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Role-specific masking, maintenance/unmasking, sensory matching and measurement/analysis procedures are unverified. The design label does not certify absence of actual bias. Existing-content review remains incomplete.
- Reason for missing information: Role-specific masking, maintenance/unmasking, sensory matching and measurement/analysis procedures are unverified. The design label does not certify absence of actual bias.
- Required materials and conditions: Masking of participants, clinical/research staff and outcome assessment/analysis
- Materials to obtain first: Role-specific masking and measurement/analysis records
- Further research: Proposed follow-up research on maintained masking and outcome measurement; no new search, calculation or trial was performed.
- Conditions for verification: Masking of participants, clinical/research staff and outcome assessment/analysis: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing masking of participants, clinical/research staff and outcome assessment/analysis to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP
- Related sources: S01

### N08 · WOMAC pain scale

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected existing question is reduced WOMAC pain, distinguished from WOMAC total, other subscales and VAS.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. WOMAC version, pain range/score units, assessment procedures, observer/self-report and measurement conditions are unverified. Existing-content review remains incomplete.
- Reason for missing information: WOMAC version, pain range/score units, assessment procedures, observer/self-report and measurement conditions are unverified.
- Required materials and conditions: Definition, units, range and measurement conditions of the selected pain scale
- Materials to obtain first: Original scale, measurement procedures and outcome-specific materials
- Further research: Proposed follow-up research using the same pain scale and measurement scope; no new search, calculation or trial was performed.
- Conditions for verification: Definition, units, range and measurement conditions of the selected pain scale: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing definition, units, range and measurement conditions of the selected pain scale to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary
- Related sources: S01

### N09 · Change from baseline to day 180

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The prespecified primary endpoint was WOMAC pain change from baseline to day 180; it is not recast as final absolute values or another visit’s results.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific baseline/final values, actual visit windows, repeated/intermediate results and time-specific observed denominators are unverified. Existing-content review remains incomplete.
- Reason for missing information: Group-specific baseline/final values, actual visit windows, repeated/intermediate results and time-specific observed denominators are unverified.
- Required materials and conditions: Distinctions between change, final values, timing and analysis population
- Materials to obtain first: Baseline, final/visit-specific values and observed materials
- Further research: Proposed follow-up research distinguishing change, final values and time points; no new search, calculation or trial was performed.
- Conditions for verification: Distinctions between change, final values, timing and analysis population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing distinctions between change, final values, timing and analysis population to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application.
- Related sources: S01

### N10 · Group-specific PP pain change

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original WOMAC changes in the PP population of 60 were -1.90±4.14 versus +0.61±3.97 with placebo; values, signs and groups are retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific PP/observed denominators, meaning of ±, scale range, adjusted/change calculations and individual data are unverified. No new final values, dispersion or response rates are calculated. Existing-content review remains incomplete.
- Reason for missing information: Group-specific PP/observed denominators, meaning of ±, scale range, adjusted/change calculations and individual data are unverified. No new final values, dispersion or response rates are calculated.
- Required materials and conditions: Selected group-specific changes, dispersion and group correspondence
- Materials to obtain first: Group-specific analysis/observed denominators, change calculations and dispersion materials
- Further research: Proposed follow-up research using the same estimand/population scope; no new search, calculation or trial was performed.
- Conditions for verification: Selected group-specific changes, dispersion and group correspondence: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing selected group-specific changes, dispersion and group correspondence to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
- Related sources: S01

### N11 · Original approximate -2.51 and P=.006

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The approximate between-group -2.51 points and P=.006 are retained as existing reported/explanatory values, without new calculation or confirmation.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original between-group model, exact estimand, adjustment variables, test and 95% CI are unverified or originally unreported. Existing-content review remains incomplete.
- Reason for missing information: Original between-group model, exact estimand, adjustment variables, test and 95% CI are unverified or originally unreported.
- Required materials and conditions: Original between-group estimate, P value, model and precision
- Materials to obtain first: Original model, exact output and CI for the selected comparison
- Further research: Proposed follow-up research on precision and uncertainty of the same estimand; no new search, calculation or trial was performed.
- Conditions for verification: Original between-group estimate, P value, model and precision: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing original between-group estimate, P value, model and precision to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.
- Related sources: S01

### N12 · Between-group CI and clinical-meaning gaps

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The historical account that a between-group WOMAC pain CI was absent from the preserved summary is retained. No CI is calculated from ± values, sample size or P value.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Direct materials for a prespecified pain-success threshold, CI, measurement scope and clinical importance are unverified; post hoc SMD/external criteria do not fill gaps. Existing-content review remains incomplete.
- Reason for missing information: Direct materials for a prespecified pain-success threshold, CI, measurement scope and clinical importance are unverified; post hoc SMD/external criteria do not fill gaps.
- Required materials and conditions: CI and prespecified important difference for the selected comparison
- Materials to obtain first: Original analysis output, prespecified important difference and scale correspondence
- Further research: Proposed follow-up research separating uncertainty from important differences; no new search, calculation or trial was performed.
- Conditions for verification: CI and prespecified important difference for the selected comparison: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing cI and prespecified important difference for the selected comparison to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.
- Related sources: S01

### N13 · Null VAS; separate result

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Concurrent VAS pain had an original null result, P=.299. Positive WOMAC results are not generalized to all pain scales.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific VAS values, denominators, exact timing, prespecified hierarchy, CI and between-scale correspondence are unverified. Existing-content review remains incomplete.
- Reason for missing information: Group-specific VAS values, denominators, exact timing, prespecified hierarchy, CI and between-scale correspondence are unverified.
- Required materials and conditions: Relationship between another pain result in the same trial and the selected question
- Materials to obtain first: Original VAS outcome-specific data, analysis/hierarchy and WOMAC correspondence
- Further research: Proposed follow-up research distinguishing scale-specific results and disagreement; no new search, calculation or trial was performed.
- Conditions for verification: Relationship between another pain result in the same trial and the selected question: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing relationship between another pain result in the same trial and the selected question to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation
- Related sources: S01

### N14 · PP 60: selection criteria

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original primary efficacy population was 60/80 PP participants with at least 80% adherence and no major deviation, distinct from the safety population of 80 and randomized 40/40.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific PP denominators, time-specific observations, deviation/attrition reasons and the selected question’s actual analysis population are not verified in detail. Existing-content review remains incomplete.
- Reason for missing information: Group-specific PP denominators, time-specific observations, deviation/attrition reasons and the selected question’s actual analysis population are not verified in detail.
- Required materials and conditions: Inclusion criteria and group-specific denominators for the primary PP efficacy population
- Materials to obtain first: Group-specific PP inclusion/exclusion, observation and deviation materials
- Further research: Proposed follow-up research on differences between PP-selected and randomized populations; no new search, calculation or trial was performed.
- Conditions for verification: Inclusion criteria and group-specific denominators for the primary PP efficacy population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing inclusion criteria and group-specific denominators for the primary PP efficacy population to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application.
- Related sources: S01

### N15 · 20/80 (25%) excluded

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original exclusion of 20/80 (25%) is retained; exclusions are not all relabeled as follow-up losses or a single reason.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific adherence/deviation versus missingness/discontinuation, missingness assumptions and sensitivity results are unverified. Existing-content review remains incomplete.
- Reason for missing information: Group-specific adherence/deviation versus missingness/discontinuation, missingness assumptions and sensitivity results are unverified.
- Required materials and conditions: Reasons, group distribution and outcome implications of efficacy exclusions
- Materials to obtain first: Group-specific exclusion reasons, observation/missingness and analysis handling
- Further research: Proposed follow-up research on uncertainty under exclusion/missingness assumptions; no new search, calculation or trial was performed.
- Conditions for verification: Reasons, group distribution and outcome implications of efficacy exclusions: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing reasons, group distribution and outcome implications of efficacy exclusions to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application.
- Related sources: S01

### N16 · ITT described as the same direction

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account describes ITT only as the same direction; this does not fill equal effect sizes, significance, CI or confirmation of PP results.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Selected-outcome ITT values, group denominators, model, missingness handling and CI/P are unverified. Existing-content review remains incomplete.
- Reason for missing information: Selected-outcome ITT values, group denominators, model, missingness handling and CI/P are unverified.
- Required materials and conditions: ITT population, estimand, precision and relationship to PP
- Materials to obtain first: Outcome-specific ITT estimates, denominators, missingness model and PP correspondence
- Further research: Proposed follow-up research distinguishing different ITT/PP analysis scopes; no new search, calculation or trial was performed.
- Conditions for verification: ITT population, estimand, precision and relationship to PP: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing iTT population, estimand, precision and relationship to PP to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.
- Related sources: S01

### N17 · PP Kellgren–Lawrence imbalance

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account of PP Kellgren–Lawrence grade-distribution imbalance, P=.037, is retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific stage distributions, pain/other baseline differences, adjustment and sensitivity materials are unverified. No adjusted effect is newly calculated. Existing-content review remains incomplete.
- Reason for missing information: Group-specific stage distributions, pain/other baseline differences, adjustment and sensitivity materials are unverified. No adjusted effect is newly calculated.
- Required materials and conditions: Baseline disease-stage distribution and adjustment in the PP population
- Materials to obtain first: PP baseline characteristics and adjustment/sensitivity materials
- Further research: Proposed follow-up research on baseline imbalance and population selection; no new search, calculation or trial was performed.
- Conditions for verification: Baseline disease-stage distribution and adjustment in the PP population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing baseline disease-stage distribution and adjustment in the PP population to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application.
- Related sources: S01

### N18 · Co-exposure and adherence

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: The PP inclusion criterion of at least 80% adherence is distinguished from actual participant-specific adherence.
- Why unverified: The currently required information is unverified in the preserved summary. Concurrent analgesics, rehabilitation/activity, other supplements, rescue medication and actual adherence measurement/discontinuation are unverified. No new treatment/exercise methods are created. Existing-content review remains incomplete.
- Reason for missing information: Concurrent analgesics, rehabilitation/activity, other supplements, rescue medication and actual adherence measurement/discontinuation are unverified. No new treatment/exercise methods are created.
- Required materials and conditions: Pain-related co-exposure and adherence/change records
- Materials to obtain first: Group-specific co-exposure, adherence, change and rescue-medication records
- Further research: Proposed follow-up research on co-exposure and attribution of product results; no new search, calculation or trial was performed.
- Conditions for verification: Pain-related co-exposure and adherence/change records: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing pain-related co-exposure and adherence/change records to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design
- Related sources: S01

### N19 · KCT and prospective registration

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original registration identifier KCT0005507 and prospective-registration account are retained; identifier format is not changed and no new registration status is certified.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Registration full text, change history, protocol/SAP and comparison with actual recruitment/analysis timing remain unread. Existing-content review remains incomplete.
- Reason for missing information: Registration full text, change history, protocol/SAP and comparison with actual recruitment/analysis timing remain unread.
- Required materials and conditions: Original registration identity, prespecified endpoints/analyses and changes
- Materials to obtain first: Original registration history, protocol and SAP
- Further research: Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed.
- Conditions for verification: Original registration identity, prespecified endpoints/analyses and changes: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing original registration identity, prespecified endpoints/analyses and changes to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N20 · Two pain scales and prespecified hierarchy

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The prespecified primary endpoint was baseline-to-day-180 WOMAC pain change; concurrent VAS was a separate pain outcome. The original false marker for split coprimary results is not converted into a new coprimary declaration.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. VAS prespecified hierarchy, actual assessment windows, multiple outcome/time-point tests, multiplicity handling and SAP are unverified. Existing-content review remains incomplete.
- Reason for missing information: VAS prespecified hierarchy, actual assessment windows, multiple outcome/time-point tests, multiplicity handling and SAP are unverified.
- Required materials and conditions: Prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS
- Materials to obtain first: Original endpoint hierarchy, timing and multiplicity plans
- Further research: Proposed follow-up research distinguishing endpoint estimates and prespecified hierarchy; no new search, calculation or trial was performed.
- Conditions for verification: Prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.
- Related sources: S01

### N21 · Sample size: 10-point WOMAC total difference

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original sample-size calculation assumed a 10-point WOMAC total difference rather than WOMAC pain; those 10 points do not become a prespecified pain-success threshold.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Planned variance, power, attrition assumptions and precision scope for pain/VAS are unverified. Existing-content review remains incomplete.
- Reason for missing information: Planned variance, power, attrition assumptions and precision scope for pain/VAS are unverified.
- Required materials and conditions: Sample-size planning endpoint/assumptions and selected result
- Materials to obtain first: Sample-size calculation plan/assumptions and endpoint-specific precision
- Further research: Proposed follow-up research on planning assumptions and actual endpoints; no new search, calculation or trial was performed.
- Conditions for verification: Sample-size planning endpoint/assumptions and selected result: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing sample-size planning endpoint/assumptions and selected result to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.
- Related sources: S01

### N22 · Post hoc SMD and external important difference

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The authors’ post hoc interpretation that observed SMD 0.46 exceeded external AAOS minimum difference 0.39 is retained as original history; the original account states no clinical-success threshold was prespecified.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. SMD definition, corresponding endpoint, denominator, CI and population/scale/applicability scope of the external criterion are unverified. No new standardized effect or success certification is made. Existing-content review remains incomplete.
- Reason for missing information: SMD definition, corresponding endpoint, denominator, CI and population/scale/applicability scope of the external criterion are unverified. No new standardized effect or success certification is made.
- Required materials and conditions: Prespecified success threshold versus post hoc interpretation/external criteria
- Materials to obtain first: Prespecified important difference, original analysis and external-criterion correspondence
- Further research: Proposed follow-up research distinguishing important differences from post hoc interpretation; no new search, calculation or trial was performed.
- Conditions for verification: Prespecified success threshold versus post hoc interpretation/external criteria: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing prespecified success threshold versus post hoc interpretation/external criteria to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internal extension boundaries; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.
- Related sources: S01

### N23 · One trial, sibling sheets and independence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The same Kim DU 2025 report, KCT0005507, 80 participants/PP60, two scales, time points and sibling sheets are not totaled as new independent trials/participants. Original R1/I0 are historical parent-verdict context.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. External comparison of actual unique trial/participant correspondence and independent replication is unverified. Existing-content review remains incomplete.
- Reason for missing information: External comparison of actual unique trial/participant correspondence and independent replication is unverified.
- Required materials and conditions: Report–trial–population–outcome relationships and independent replication materials
- Materials to obtain first: Report/registration/population/outcome relationships and separate replication materials
- Further research: Proposed follow-up research distinguishing separate evidence for the same formulation/question; no new search, calculation or trial was performed.
- Conditions for verification: Report–trial–population–outcome relationships and independent replication materials: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing report–trial–population–outcome relationships and independent replication materials to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N24 · Research and publication support

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account that NEWTREE Co., Ltd. supported research and publication is retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original support contracts, amounts, individual costs/roles and disclosures remain unread; publication support does not establish every cost item was verified. Existing-content review remains incomplete.
- Reason for missing information: Original support contracts, amounts, individual costs/roles and disclosures remain unread; publication support does not establish every cost item was verified.
- Required materials and conditions: Separate funding and research/publication support roles
- Materials to obtain first: Original research/publication support contracts, roles and disclosures
- Further research: Proposed follow-up research on support roles and outcome reporting; no new search, calculation or trial was performed.
- Conditions for verification: Separate funding and research/publication support roles: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing separate funding and research/publication support roles to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N25 · Product and placebo manufacturing

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account that NEWTREE manufactured tested product and placebo is retained.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Manufacturing/batches, supply contracts, whether provision was free and role details are unverified. Manufacturing alone does not fill free-support details. Existing-content review remains incomplete.
- Reason for missing information: Manufacturing/batches, supply contracts, whether provision was free and role details are unverified. Manufacturing alone does not fill free-support details.
- Required materials and conditions: Individual records of manufacturing and free-product support/batches
- Materials to obtain first: Manufacturing, product/placebo supply, batches and cost materials
- Further research: Proposed follow-up research distinguishing manufacturing from supply roles; no new search, calculation or trial was performed.
- Conditions for verification: Individual records of manufacturing and free-product support/batches: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing individual records of manufacturing and free-product support/batches to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed
- Related sources: S01

### N26 · Company and subsidiary authors

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original Korean account states Do-Un Kim was a NEWTREE employee and Seung Un Kim was affiliated with subsidiary EVERSPRING; the complete original summary also retains the English employment/affiliation account.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original author-specific employment, contributions, equity/other relationships, timing and disclosures remain unread; no current affiliations/relationships are certified. Existing-content review remains incomplete.
- Reason for missing information: Original author-specific employment, contributions, equity/other relationships, timing and disclosures remain unread; no current affiliations/relationships are certified.
- Required materials and conditions: Author-specific affiliations/employment versus contributions/COI
- Materials to obtain first: Author-specific affiliation, contribution, employment and COI disclosures
- Further research: Proposed follow-up research distinguishing author relationships and reporting roles; no new search, calculation or trial was performed.
- Conditions for verification: Author-specific affiliations/employment versus contributions/COI: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing author-specific affiliations/employment versus contributions/COI to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N27 · Declaration of company nonparticipation

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved account states the paper declared that neither company participated in design, recruitment, collection, analysis or interpretation; this declaration is not new confirmation of independence.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Actual analysis/data access, author contributions, writing/publication roles and role-specific original records remain unread. Existing-content review remains incomplete.
- Reason for missing information: Actual analysis/data access, author contributions, writing/publication roles and role-specific original records remain unread.
- Required materials and conditions: Declared and actual roles in design, recruitment, collection, analysis and interpretation
- Materials to obtain first: Role declarations, contributions and analysis/writing/publication materials
- Further research: Proposed follow-up research on declarations and individual roles; no new search, calculation or trial was performed.
- Conditions for verification: Declared and actual roles in design, recruitment, collection, analysis and interpretation: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing declared and actual roles in design, recruitment, collection, analysis and interpretation to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N28 · Safety population of 80 and events

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Safety analysis included all 80 participants. The original account records one urticaria event judged unrelated to product, recovery without sequelae and no serious adverse event.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific safety denominators, observation windows, collection criteria, discontinuation, judgment procedures and long-term/vulnerable-population harms are unverified. No new rates, causal judgments or all-safety certification are made. Existing-content review remains incomplete.
- Reason for missing information: Group-specific safety denominators, observation windows, collection criteria, discontinuation, judgment procedures and long-term/vulnerable-population harms are unverified. No new rates, causal judgments or all-safety certification are made.
- Required materials and conditions: Safety population, harms collection, original events and relatedness judgments
- Materials to obtain first: Harms collection, group-specific denominators, events/discontinuation and judgment materials
- Further research: Proposed follow-up research on harms-reporting scope and subsequent follow-up; no new search, calculation or trial was performed.
- Conditions for verification: Safety population, harms collection, original events and relatedness judgments: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing safety population, harms collection, original events and relatedness judgments to link required evidence with current materials for the selected question.
- Application exceptions: Supplement the selected subclaim’s safety-material gaps; pain-scale results or parent safety wording do not determine safety, generate harms rates or create new usage instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application
- Related sources: S01

### N29 · Other collagen and opposing materials

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Undenatured type II and ordinary hydrolyzed type I/III differ in composition; the original context mentions null trials. They do not become the selected product’s direct comparison or new reports.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Individual bibliographies, compositions, populations, timing and estimands of mentioned other trials are not linked in the current preserved summary and remain unverified. Existing-content review remains incomplete.
- Reason for missing information: Individual bibliographies, compositions, populations, timing and estimands of mentioned other trials are not linked in the current preserved summary and remain unverified.
- Required materials and conditions: Other-composition trial identity and correspondence to the same formulation/question
- Materials to obtain first: Each mentioned report and composition/population-specific materials
- Further research: Proposed follow-up research distinguishing applicability across compositions/results; no new search, calculation or trial was performed.
- Conditions for verification: Other-composition trial identity and correspondence to the same formulation/question: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing other-composition trial identity and correspondence to the same formulation/question to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied.
- Related sources: S01

### N30 · Other populations and long-term/clinical outcomes

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original results concern the specific low-molecular-weight peptide and early knee osteoarthritis; they are not generalized to all collagen, all pain scales, advanced disease or long-term clinical outcomes.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Other preparations, disease stages, durations/doses, long-term functional/structural results and vulnerable-population materials are unverified. Existing-content review remains incomplete.
- Reason for missing information: Other preparations, disease stages, durations/doses, long-term functional/structural results and vulnerable-population materials are unverified.
- Required materials and conditions: Applicability and follow-up beyond the tested preparation, population and duration
- Materials to obtain first: Additional population, preparation, duration and long-term clinical/harms materials
- Further research: Proposed follow-up research distinguishing the selected question from other conditions; no new search, calculation or trial was performed.
- Conditions for verification: Applicability and follow-up beyond the tested preparation, population and duration: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing applicability and follow-up beyond the tested preparation, population and duration to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP
- Related sources: S01

### N31 · Original values, axes, Korean/English and history

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The complete original summary retains parent C50, B/P/R1/I0/E+/B2, unrecorded precision, three false markers, empty override reasons, Korean/English, 2026-08-26, empty corrections/deliberation and selected subclaim grade/note.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Historical cross-check/full-text-review accounts do not establish current review/reading or satisfied subclaim conditions. Absent subclaim score/status/axes and parent classification keys are not filled. Existing-content review remains incomplete.
- Reason for missing information: Historical cross-check/full-text-review accounts do not establish current review/reading or satisfied subclaim conditions. Absent subclaim score/status/axes and parent classification keys are not filled.
- Required materials and conditions: Selected subclaim versus original parent values, reference dates and correction/history
- Materials to obtain first: Original verdict, correction/change text and user comments
- Further research: Proposed updating research distinguishing original-material changes from preparation versions; no new search, calculation or trial was performed.
- Conditions for verification: Selected subclaim versus original parent values, reference dates and correction/history: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing selected subclaim versus original parent values, reference dates and correction/history to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed
- Related sources: S01

### N32 · Summary read; external material unread

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved summary was read for preparation, linking Kim DU 2025 bibliography/URL with PMID40977985. External papers, registration, protocols, SAP and original funding/COI disclosures remain unread without attempted access.
- Why unverified: Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Bibliography links or KCT identifiers do not upgrade external acquisition, reading or review. No separate external-link/click check is performed. Existing-content review remains incomplete.
- Reason for missing information: Bibliography links or KCT identifiers do not upgrade external acquisition, reading or review. No separate external-link/click check is performed.
- Required materials and conditions: Material-specific actual reading, identity/URL and additional-material gaps
- Materials to obtain first: Original paper, registration/plans, individual disclosures and user comments
- Further research: A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.
- Conditions for verification: Material-specific actual reading, identity/URL and additional-material gaps: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.
- Why this condition is needed: Preparation item distinguishing material-specific actual reading, identity/URL and additional-material gaps to link required evidence with current materials for the selected question.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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: S01

## Evidence and sources

### S01

Kim DU et al. 2025

[PubMed](https://pubmed.ncbi.nlm.nih.gov/40977985/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: -1.90±4.14 versus +0.61±3.97, approximate between-group -2.51 points, P=.006; VAS P=.299. Selected WOMAC concerns original prespecified day-180 baseline change in PP60/P=.006. Approximate -2.51 is an existing historical reported/explanatory value, not a new calculation. The preserved historical account of absent between-group CI is retained.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Kim DU2025/KCT0005507 concerns a double-blind placebo-controlled 180-day trial in 80 adults with Kellgren–Lawrence grade 1–2, randomized 40/40. Primary PP60/80 with exclusion of 20/80 (25%) for the specific 3-g-daily low-molecular-weight peptide is distinct from safety population of 80. Prespecified primary day-180 WOMAC pain change of -1.90±4.14 versus +0.61±3.97, approximate between-group -2.51 points/P=.006, and concurrent VAS P=.299 are different scales/results. Exact VAS timing, observed/analysis denominators, group values/CI/hierarchy are unverified in the current summary. Same-direction ITT accounts, PP KL imbalance P=.037, the 10-point WOMAC total sample-size assumption, post hoc SMD 0.46/external AAOS 0.39 and manufacturer support/author-relationship gaps are distinguished. The same report, registration, 80 participants/PP60, groups, scales, time points and sibling sheets are not totaled as new independent trials/participants. Report/material slots do not establish unique clinical-trial, participant or independent-replication totals; no new totals or independence certification are made.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
- Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
- Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
- Review incomplete: Existing content review remains incomplete.
- Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
- Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
- Not applicable: Not used as a substitute for an evidence gap.
- Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
- Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

## Change history

2026-10-12 · Public page/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.