{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Topical 10% peppermint oil × Response at 120 minutes in acute tension-type headache",
  "language": "en",
  "translation_date": "2026-10-20",
  "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "How does the selected 120-minute response differ from the parent verdict?",
      "needed": "Distinction between the selected question, grade, original explanation and parent context",
      "role": "Required",
      "role_reason": "This condition links Distinction between the selected question, grade, original explanation and parent context with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between the selected question, grade, original explanation and parent context must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Individual score, status and axes are absent from the selection. Original selected and parent records must be linked without automatically assigning parent values to the subclaim. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which population with acute tension-type headache was studied?",
      "needed": "Diagnosis, eligibility, age and attack selection in the follow-up trial",
      "role": "Required",
      "role_reason": "This condition links Diagnosis, eligibility, age and attack selection in the follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Diagnosis, eligibility, age and attack selection in the follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original diagnostic, inclusion and exclusion, age, baseline pain, comorbidity and attack-selection rules are needed. Detailed eligibility absent from the stored summary is not filled in. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which 10% topical peppermint-oil formulation was studied?",
      "needed": "Topical formulation, concentration, vehicle, quality and application sites",
      "role": "Required",
      "role_reason": "This condition links Topical formulation, concentration, vehicle, quality and application sites with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Topical formulation, concentration, vehicle, quality and application sites must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: S02 product, manufacturing, quality, vehicle, ethanol concentration and application specifications are needed. The early formulation is not automatically treated as identical to the follow-up formulation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which trial used 90% ethanol and the 0/15/30-minute schedule?",
      "needed": "Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials",
      "role": "Required",
      "role_reason": "This condition links Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Follow-up application amount, volume, frequency, timing, vehicle and adherence records are needed. No new undiluted preparation or personal-use instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the placebo vehicle and blinding procedures verified?",
      "needed": "Sensory matching and participant and assessor blinding in the follow-up trial",
      "role": "Required",
      "role_reason": "This condition links Sensory matching and participant and assessor blinding in the follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Sensory matching and participant and assessor blinding in the follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: S02 control formulation, vehicle, sensory differences, blinding procedures and assessment records are needed. Unread external material is not converted into procedure verification or blinding failure. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are 209 starters and 189 in FAS distinguished?",
      "needed": "Participant flow across starting, allocation, analysis populations and individual outcomes",
      "role": "Required",
      "role_reason": "This condition links Participant flow across starting, allocation, analysis populations and individual outcomes with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Participant flow across starting, allocation, analysis populations and individual outcomes must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original flow diagrams, arm-specific allocation, FAS definitions, exclusion reasons and other analysis populations are needed. Preserved counts are not arbitrarily relabeled as recruitment, allocation or completion counts. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "How are 120-minute responders and denominators linked?",
      "needed": "Correspondence between original arm labels, responders, denominators and analysis populations",
      "role": "Required",
      "role_reason": "This condition links Correspondence between original arm labels, responders, denominators and analysis populations with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Correspondence between original arm labels, responders, denominators and analysis populations must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original arm-specific VPRS tables, denominator definitions, arm labels and missing-data handling are needed. New response rates, effects or CIs are not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "How were FAS exclusions and missing outcomes handled?",
      "needed": "Analysis populations, missing assessments, rescue medication and sensitivity analyses",
      "role": "Required",
      "role_reason": "This condition links Analysis populations, missing assessments, rescue medication and sensitivity analyses with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Analysis populations, missing assessments, rescue medication and sensitivity analyses must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: FAS, ITT and PP definitions, handling of exclusions, missingness, rescue medication and protocol deviations, and sensitivity analyses are needed. Unverified missing-data policies are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What is the exact definition of a VPRS response?",
      "needed": "Scale, response threshold, baseline conditions, assessors and measurement window",
      "role": "Required",
      "role_reason": "This condition links Scale, response threshold, baseline conditions, assessors and measurement window with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Scale, response threshold, baseline conditions, assessors and measurement window must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original VPRS items, response criteria, baseline pain, assessment manuals and timing are needed. Definitions absent from the stored summary are not added. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Is the 120-minute response the same as early pain findings from 15 minutes?",
      "needed": "Distinction between trial-specific time points, scales and assessment units",
      "role": "Required",
      "role_reason": "This condition links Distinction between trial-specific time points, scales and assessment units with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between trial-specific time points, scales and assessment units must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Time-specific results, scales, prespecified outcomes and analysis units from both reports are needed. Persistence or the same target effect is not inferred without direct linking information. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What was the prespecified order of the first primary endpoint and VAS-SPID?",
      "needed": "Hierarchy and testing rules for VPRS and VAS-SPID",
      "role": "Required",
      "role_reason": "This condition links Hierarchy and testing rules for VPRS and VAS-SPID with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Hierarchy and testing rules for VPRS and VAS-SPID must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Complete initial registration, protocols, analysis plans, amendment history and hierarchy rules are needed. Preserved statements about prespecification are not converted into current reading of original plans. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What is the prespecified one-sided Fisher .025 threshold?",
      "needed": "Prespecified test direction, significance level, exact P value and decision rule",
      "role": "Required",
      "role_reason": "This condition links Prespecified test direction, significance level, exact P value and decision rule with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Prespecified test direction, significance level, exact P value and decision rule must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original prespecified testing plans, direction, significance level, exact P value and analysis output are needed. A two-sided calculation is not substituted for the prespecified one-sided result. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Whose calculation is the two-sided Fisher P≈.101?",
      "needed": "Distinction between the original prespecified analysis and the historical Codex calculation",
      "role": "Required",
      "role_reason": "This condition links Distinction between the original prespecified analysis and the historical Codex calculation with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between the original prespecified analysis and the historical Codex calculation must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original prespecified analysis output and historical calculation records are separately needed. The historical value is not relabeled as a one-sided P value prespecified and reported by the trial. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are precision and importance of the 120-minute effect established?",
      "needed": "Original between-arm effect measure, CI, clinical importance threshold and sample-size plan",
      "role": "Required",
      "role_reason": "This condition links Original between-arm effect measure, CI, clinical importance threshold and sample-size plan with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Original between-arm effect measure, CI, clinical importance threshold and sample-size plan must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original between-arm estimates, CIs, effect measures, clinical importance thresholds and sample-size plans are needed. New RDs, RRs, CIs or importance thresholds are not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Does missing the prespecified threshold establish an exact zero effect?",
      "needed": "Separate preservation of the failed threshold, effect direction and uncertainty",
      "role": "Required",
      "role_reason": "This condition links Separate preservation of the failed threshold, effect direction and uncertainty with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Separate preservation of the failed threshold, effect direction and uncertainty must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original estimates, CIs and testing plans are needed. This is not converted into exact zero effects, equivalence, established efficacy or a new grade. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "How far can the second VAS-SPID endpoint be interpreted?",
      "needed": "VAS-SPID definition, time window, estimation and interpretation after hierarchical testing",
      "role": "Required",
      "role_reason": "This condition links VAS-SPID definition, time window, estimation and interpretation after hierarchical testing with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for VAS-SPID definition, time window, estimation and interpretation after hierarchical testing must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original VAS-SPID definitions, result tables, estimates, CIs, P values and prespecified hierarchy are needed. Exact findings absent from the summary are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Do the early 41 participants and 164 attacks represent the same denominator?",
      "needed": "Distinction between patients, repeated attacks, treatment order and analysis units",
      "role": "Required",
      "role_reason": "This condition links Distinction between patients, repeated attacks, treatment order and analysis units with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between patients, repeated attacks, treatment order and analysis units must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Attacks per patient, patient and attack flow, correlation structure, completion denominators and analysis models are needed. New participant or event totals are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are sequence, period and carryover effects in the crossover trial verified?",
      "needed": "Treatment sequence, washout, carryover, period effects and repeated-data handling",
      "role": "Required",
      "role_reason": "This condition links Treatment sequence, washout, carryover, period effects and repeated-data handling with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Treatment sequence, washout, carryover, period effects and repeated-data handling must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original crossover protocols, analysis plans, period-specific results and handling of repeated observations are needed. Unread originals are not labeled as verified procedures. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are the small early positive finding and larger follow-up failure both preserved?",
      "needed": "Findings and directness across different trials, outcomes and designs",
      "role": "Required",
      "role_reason": "This condition links Findings and directness across different trials, outcomes and designs with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Findings and directness across different trials, outcomes and designs must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Populations, formulations, outcomes, timing, protocols and analyses from both reports are needed. New confirmation of matched independent replication for the same target effect is not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Is equivalence to acetaminophen the same question?",
      "needed": "Distinction between placebo comparisons and separate equivalence or noninferiority designs",
      "role": "Required",
      "role_reason": "This condition links Distinction between placebo comparisons and separate equivalence or noninferiority designs with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between placebo comparisons and separate equivalence or noninferiority designs must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original comparison designs, results, equivalence margins, tests and CIs are needed. No new judgment establishing equivalence or noninferiority is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Do EudraCT and NCT identifiers count as separate trials?",
      "needed": "Links between registration identifiers, result reports and the same trial family",
      "role": "Required",
      "role_reason": "This condition links Links between registration identifiers, result reports and the same trial family with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Links between registration identifiers, result reports and the same trial family must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original registration versions, cross-references, result documents and cohort links are needed. Current external identity verification or unique participant and replication totals are not established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "How do the registered-results version, posting date and original evidence date differ?",
      "needed": "Distinction between result posting, version, preserved evidence and production dates",
      "role": "Required",
      "role_reason": "This condition links Distinction between result posting, version, preserved evidence and production dates with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between result posting, version, preserved evidence and production dates must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original results versions, subsequent amendments and registration history are needed. Current public availability and the latest linked version are unverified; condition and view production dates are distinct from completed content review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Were original registration, protocols and analysis plans actually read?",
      "needed": "Links between prespecified plans, outcome changes and actual results",
      "role": "Required",
      "role_reason": "This condition links Links between prespecified plans, outcome changes and actual results with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Links between prespecified plans, outcome changes and actual results must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original initial registration, amendment history, protocols, analysis plans and correspondence to results are needed. External materials remain unread with access unattempted. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are rescue medication, concurrent care and actual application distinguished?",
      "needed": "Analgesic rescue medication, other care, application adherence and assessment timing",
      "role": "Supplementary",
      "role_reason": "This condition links Analgesic rescue medication, other care, application adherence and assessment timing with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Analgesic rescue medication, other care, application adherence and assessment timing must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original concurrent-medication and rescue rules, application performance, adherence, assessment records and analysis policies are needed. Effects of concurrent care are not attributed solely to peppermint oil. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are funding and manufacturer involvement in the early trial verified?",
      "needed": "Separate verification of funding, supplied products, employee authors and interests",
      "role": "Required",
      "role_reason": "This condition links Separate verification of funding, supplied products, employee authors and interests with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Separate verification of funding, supplied products, employee authors and interests must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original funding, supplied-product, author-affiliation, employee-role and COI documents are needed. Unverified entries are not filled in as independent. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Which roles are known from Cassella-med sponsorship?",
      "needed": "Sponsorship, product support, authorship, interests and analysis or publication control",
      "role": "Required",
      "role_reason": "This condition links Sponsorship, product support, authorship, interests and analysis or publication control with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Sponsorship, product support, authorship, interests and analysis or publication control must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original sponsorship, support, author affiliations, COI and analysis or publication-role documents are needed. Sponsorship alone does not establish other roles or a new independence grade. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are direct data on skin and eye harms available?",
      "needed": "Adverse-event definitions, collection, severity, arm-specific events and denominators",
      "role": "Supplementary",
      "role_reason": "This condition links Adverse-event definitions, collection, severity, arm-specific events and denominators with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Adverse-event definitions, collection, severity, arm-specific events and denominators must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: S02 original adverse-event tables, arm-specific events and denominators, collection, discontinuation, exposure and timing are needed. Evidence gaps are not labeled as safety or absence of harm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are harms comparisons and missingness for oil, ethanol and vehicle verified?",
      "needed": "Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures",
      "role": "Supplementary",
      "role_reason": "This condition links Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original arm-specific harms, exposure, concurrent exposures, observation and missingness records are needed. Vehicle effects are not converted into causality attributed to oil itself or new risk numbers. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Is safety established for repeated or long-term use and vulnerable groups?",
      "needed": "Distinction between acute trials and repeated-use, long-term and age-specific harms",
      "role": "Supplementary",
      "role_reason": "This condition links Distinction between acute trials and repeated-use, long-term and age-specific harms with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between acute trials and repeated-use, long-term and age-specific harms must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Direct safety information for repeated or long-term use, ages and vulnerable groups is needed. Unlinked materials are not used to create new application, discontinuation or treatment instructions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Can findings be extended to other formulations, headache types or long-term outcomes?",
      "needed": "Scope of topical formulation, tension-type headache and acute response",
      "role": "Required",
      "role_reason": "This condition links Scope of topical formulation, tension-type headache and acute response with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Scope of topical formulation, tension-type headache and acute response must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Separate information on the relevant formulation, condition, period and direct comparisons is needed. Effects of different exposures are not transferred merely because names are shared. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are the parent's representative details and assessment axes the same as the follow-up outcome?",
      "needed": "Distinction between parent early-trial details and the selected follow-up trial",
      "role": "Required",
      "role_reason": "This condition links Distinction between parent early-trial details and the selected follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Distinction between parent early-trial details and the selected follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original formulation, population, timing and outcome records must be linked to the applicable scope of parent flags. Preserved assessment flags do not establish new content review or subclaim assessment. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are original Korean and English wording, grades and correction history retained?",
      "needed": "Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records",
      "role": "Required",
      "role_reason": "This condition links Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Complete original materials, the selected explanation, authorized corrections and prior-version records are needed. Scores, status or axes absent from the selection, or new deliberation findings, are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are reading of stored summaries and external originals distinguished?",
      "needed": "Actual reading, material type, links and access scope for each report",
      "role": "Required",
      "role_reason": "This condition links Actual reading, material type, links and access scope for each report with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created.",
      "criterion": "Original material for Actual reading, material type, links and access scope for each report must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Authorized external originals, registered results, original registration, protocols, analysis plans and support documents are needed. Links or needed-material entries are not converted into acquisition, full-text reading or completed clinical review. This records needed materials; no new research was executed."
    }
  ]
}