{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Low-molecular-weight collagen peptide · VAS pain in early knee osteoarthritis — Evidence Check",
  "language": "en",
  "translation_date": "2026-10-13",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected question and original subclaim values",
      "needed": "Selected question grade/note, parent context and presence of score/status/axes",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed updating research linking original-question scope to additional materials; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Early knee osteoarthritis population",
      "needed": "Actual disease stage, recruitment criteria and baseline characteristics",
      "role": "Required",
      "role_reason": "Preparation item distinguishing actual disease stage, recruitment criteria and baseline characteristics to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on applicability and heterogeneity within the same population scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Specific low-molecular-weight peptide",
      "needed": "Identity, composition and exposure of the tested preparation",
      "role": "Required",
      "role_reason": "Preparation item distinguishing identity, composition and exposure of the tested preparation to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing formulation differences and result attribution; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Placebo, manufacturing and control conditions",
      "needed": "Actual placebo identity, matching and accompanying conditions",
      "role": "Required",
      "role_reason": "Preparation item distinguishing actual placebo identity, matching and accompanying conditions to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on control conditions and measurement bias; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Research exposure: 3 g daily for 180 days",
      "needed": "Original dose/duration and actual exposure/discontinuation",
      "role": "Required",
      "role_reason": "Preparation item distinguishing original dose/duration and actual exposure/discontinuation to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing dose/duration-specific applicability; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "80 randomized; 40/40",
      "needed": "Allocation unit, generation/concealment and group denominators",
      "role": "Required",
      "role_reason": "Preparation item distinguishing allocation unit, generation/concealment and group denominators to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on allocation procedures and actual populations; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Double blinding and measurement roles",
      "needed": "Masking of participants, clinical/research staff and outcome assessment/analysis",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on maintained masking and outcome measurement; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "VAS pain scale",
      "needed": "Definition, units, range and measurement conditions of the selected VAS",
      "role": "Required",
      "role_reason": "Preparation item distinguishing definition, units, range and measurement conditions of the selected VAS to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "Definition, units, range and measurement conditions of the selected VAS: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research using the same scale and measurement scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "VAS assessment timing and change versus final values",
      "needed": "Actual VAS timing, change/final values and observed population",
      "role": "Required",
      "role_reason": "Preparation item distinguishing actual VAS timing, change/final values and observed population to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "Actual VAS timing, change/final values and observed population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M08 §8.2.2, M15 §15.3.1; our own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing scales, timing and change/final values; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "VAS P=.299: original null-result account",
      "needed": "VAS between-group testing distinguished from estimation and precision",
      "role": "Required",
      "role_reason": "Preparation item distinguishing vAS between-group testing distinguished from estimation and precision to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "VAS between-group testing distinguished from estimation and precision: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing nonsignificance from uncertainty; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "VAS analysis denominators and ITT/PP",
      "needed": "Actual VAS analysis population and group-specific denominators",
      "role": "Required",
      "role_reason": "Preparation item distinguishing actual VAS analysis population and group-specific denominators to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "Actual VAS analysis population and group-specific denominators: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing outcome-specific populations and missingness assumptions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "VAS important difference and success threshold",
      "needed": "Prespecified VAS important difference, precision and interpretation scope",
      "role": "Required",
      "role_reason": "Preparation item distinguishing prespecified VAS important difference, precision and interpretation scope to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "Prespecified VAS important difference, precision and interpretation scope: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on scale-specific important differences and uncertainty; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Positive WOMAC: a separate result",
      "needed": "Relationship between WOMAC and VAS results/hierarchy in the same report",
      "role": "Required",
      "role_reason": "Preparation item distinguishing relationship between WOMAC and VAS results/hierarchy in the same report to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "Relationship between WOMAC and VAS results/hierarchy in the same report: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied; M08 Table 8.2.a, M04 §4.6.3; internal application.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing scale-specific results and disagreement; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "PP 60: selection criteria",
      "needed": "Inclusion criteria and group-specific denominators for the primary PP efficacy population",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on differences between PP-selected and randomized populations; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "20/80 (25%) excluded",
      "needed": "Reasons, group distribution and outcome implications of efficacy exclusions",
      "role": "Required",
      "role_reason": "Preparation item distinguishing reasons, group distribution and outcome implications of efficacy exclusions to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on uncertainty under exclusion/missingness assumptions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "ITT described as the same direction",
      "needed": "ITT population, estimand, precision and relationship to PP",
      "role": "Required",
      "role_reason": "Preparation item distinguishing iTT population, estimand, precision and relationship to PP to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing different ITT/PP analysis scopes; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "PP Kellgren–Lawrence imbalance",
      "needed": "Baseline disease-stage distribution and adjustment in the PP population",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on baseline imbalance and population selection; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Co-exposure and adherence",
      "needed": "Pain-related co-exposure and adherence/change records",
      "role": "Required",
      "role_reason": "Preparation item distinguishing pain-related co-exposure and adherence/change records to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on co-exposure and attribution of product results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "KCT and prospective registration",
      "needed": "Original registration identity, prespecified endpoints/analyses and changes",
      "role": "Required",
      "role_reason": "Preparation item distinguishing original registration identity, prespecified endpoints/analyses and changes to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Two pain scales and prespecified hierarchy",
      "needed": "Prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing endpoint estimates and prespecified hierarchy; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Sample size: 10-point WOMAC total difference",
      "needed": "Sample-size planning endpoint/assumptions and selected result",
      "role": "Required",
      "role_reason": "Preparation item distinguishing sample-size planning endpoint/assumptions and selected result to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on planning assumptions and actual endpoints; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Post hoc SMD and external important difference",
      "needed": "Prespecified success threshold versus post hoc interpretation/external criteria",
      "role": "Required",
      "role_reason": "Preparation item distinguishing prespecified success threshold versus post hoc interpretation/external criteria to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing important differences from post hoc interpretation; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "One trial, sibling sheets and independence",
      "needed": "Report–trial–population–outcome relationships and independent replication materials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing report–trial–population–outcome relationships and independent replication materials to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing separate evidence for the same formulation/question; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Research and publication support",
      "needed": "Separate funding and research/publication support roles",
      "role": "Required",
      "role_reason": "Preparation item distinguishing separate funding and research/publication support roles to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on support roles and outcome reporting; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Product and placebo manufacturing",
      "needed": "Individual records of manufacturing and free-product support/batches",
      "role": "Required",
      "role_reason": "Preparation item distinguishing individual records of manufacturing and free-product support/batches to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing manufacturing from supply roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Company and subsidiary authors",
      "needed": "Author-specific affiliations/employment versus contributions/COI",
      "role": "Required",
      "role_reason": "Preparation item distinguishing author-specific affiliations/employment versus contributions/COI to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing author relationships and reporting roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Declaration of company nonparticipation",
      "needed": "Declared and actual roles in design, recruitment, collection, analysis and interpretation",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on declarations and individual roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Safety population of 80 and events",
      "needed": "Safety population, harms collection, original events and relatedness judgments",
      "role": "Supplementary",
      "role_reason": "Preparation item distinguishing safety population, harms collection, original events and relatedness judgments to link required evidence with current materials for the selected question.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on harms-reporting scope and subsequent follow-up; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Other collagen and opposing materials",
      "needed": "Other-composition trial identity and correspondence to the same formulation/question",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing applicability across compositions/results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Other populations and long-term/clinical outcomes",
      "needed": "Applicability and follow-up beyond the tested preparation, population and duration",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing the selected question from other conditions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Original values, axes, Korean/English and history",
      "needed": "Selected subclaim versus original parent values, reference dates and correction/history",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed updating research distinguishing original-material changes from preparation versions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Summary read; external material unread",
      "needed": "Material-specific actual reading, identity/URL and additional-material gaps",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion."
    }
  ]
}