{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral berberine alone or combined with letrozole × Cumulative live birth in infertility associated with PCOS",
  "language": "en",
  "translation_date": "2026-10-27",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-05",
  "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; distinguish intervention variants.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Link studies and reports separately; do not omit studies solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method 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.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.",
    "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.",
    "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.",
    "Not applicable": "The condition has no applicable subject within the current retained set and narrow question. This does not replace a material gap or unread status.",
    "Not reported": "Limited to the particular material or section actually read. It is not extended to the entirety of an unread external paper.",
    "Review incomplete": "A status for external original-material comparison not yet performed, distinguished from review of locally retained content."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Is the question bounded to cumulative live birth when berberine is added to the same letrozole treatment?",
      "needed": "Linked records of the original claim, intervention, comparator and derived-comparison boundary",
      "role": "Required",
      "role_reason": "The additional contribution on a common letrozole background must be distinguished from the effect of replacing treatment with monotherapy.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Retain the original claim and identify letrozole plus berberine versus letrozole alone as a derived comparison.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If the boundary changes, redefine the actual intervention/comparator combination and review it in a separate version."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Does the text distinguish the combination arm, the common letrozole control and the roles of double-dummy placebos?",
      "needed": "Records of active ingredients, placebo allocation and actual comparator roles in the 3 arms",
      "role": "Required",
      "role_reason": "A common active comparator must be retained to distinguish the effect of letrozole itself from the additional contribution of berberine.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Select letrozole plus berberine and letrozole alone; do not interpret the double-dummy design as a pure untreated placebo control.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If the full protocol is obtained, compare active/placebo allocation by arm and keep different strategies distinct."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are the trial berberine’s exact salt form, source, product and standardization established?",
      "needed": "Berberine product name, manufacturer, salt form, batch and standardization material",
      "role": "Required",
      "role_reason": "Product matching prevents the result of adding berberine to letrozole from being transferred to the add-on effect of arbitrary salts or botanical combinations.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish the exact chemical form, product identifier, source, content standardization and application to the selected arm.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If original product material is obtained, compare composition and standardization and review unmatched products as separate questions."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are the planned oral dose, actual intake and adherence for the added berberine established?",
      "needed": "Arm-specific prescriptions, adherence, actual daily doses and discontinuation records",
      "role": "Required",
      "role_reason": "Actual exposure to the added ingredient must be compared with the planned dose to interpret its contribution on the common letrozole background.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish planned oral 1.5 g/day from actual intake, adherence, discontinuation and changes.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Use dosing records to distinguish planned from actual exposure and compare the effects of deviations with the predefined analysis."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the letrozole plan, dose escalation and actual administration established as the same in the combination and control arms?",
      "needed": "Cycle-specific letrozole prescriptions, escalation, actual intake and between-arm balance in the combination and control arms",
      "role": "Required",
      "role_reason": "If actual escalation of the common background medication differed, the result is difficult to attribute solely to the additional contribution of berberine.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Check the common letrozole plan of 2.5 mg on cycle days 3–7, increasing to 5 mg if needed, and the between-arm balance of actual escalation and administration.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare letrozole administration, escalation and deviations in both arms to examine whether the common background treatment matched."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are the actual population and Rotterdam PCOS/infertility eligibility criteria sufficiently established for the selected comparison?",
      "needed": "Diagnosis, age, infertility duration, inclusion/exclusion criteria and arm-specific population characteristics",
      "role": "Required",
      "role_reason": "The population boundary prevents the add-on result from being extended to general PCOS management or other populations.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish the description of infertile women with Rotterdam PCOS and the detailed diagnostic, age and eligibility criteria.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If eligibility criteria and baseline tables are obtained, compare the target population with the actual trial population."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are baseline infertility causes, prior treatment and arm-specific prognostic characteristics established?",
      "needed": "Arm-specific baseline tables, investigations of infertility causes, prior treatment and medical histories",
      "role": "Required",
      "role_reason": "Baseline prognostic balance in the berberine add-on comparison must be examined using actual data.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish prognosis in the selected arms, including male/tubal factors, baseline ovulatory/metabolic status and previous treatment.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare baseline material with planned handling of prognostic variables and actual balance."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are actual random-sequence generation and implementation of the allocation ratio established in this multicenter trial?",
      "needed": "Random-sequence generation, stratification, site-specific allocation procedures and CONSORT flow material",
      "role": "Required",
      "role_reason": "Evaluating selection bias in the two add-on comparison arms requires more than an allocation description.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish not only the multicenter RCT and 1:1:1 description but also sequence generation, stratification and site-specific implementation.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare the protocol and allocation procedures to examine implementation of randomization for the selected arms."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are allocation concealment and recruitment procedures established for the two selected arms?",
      "needed": "Allocation concealment, enrollment timing, recruitment sequence and actual implementation material",
      "role": "Required",
      "role_reason": "Recruitment bias from predictable allocation must also be examined when comparing an addition to the same background medication.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish recruitment before allocation disclosure, concealment methods and actual implementation in the selected arms.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Obtain allocation/enrollment documents to examine concealment procedures in relation to recruitment timing."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are actual double-dummy blinding and the independence of live-birth ascertainment established?",
      "needed": "Placebo matching, maintenance/breaking of blinding, outcome assessors and verification procedures",
      "role": "Required",
      "role_reason": "This condition examines deviations in dosing, subsequent care and outcome assessment caused by knowledge of the added ingredient.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish the double-blind/double-dummy description, placebo matching, unblinding or guessability and birth-ascertainment procedures.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare protocol and ascertainment documents to examine implementation of blinding and independence of outcome assessment."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are concomitant treatment, rescue treatment and deviations beyond the common letrozole established in both arms?",
      "needed": "Arm-specific concomitant/rescue treatment, crossover, other infertility treatment and reasons for discontinuation",
      "role": "Required",
      "role_reason": "If concomitant treatment beyond the common letrozole differed, attribution solely to added berberine is difficult.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Check concomitant, rescue and other infertility treatment and differences between the arms apart from the added ingredient.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Reconstruct arm-specific treatment pathways to examine the definition of the effect of interest and appropriate handling of deviations."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are the maximum 6-month plan, actual individual treatment/cycle counts and exposure after pregnancy established?",
      "needed": "Arm-specific actual treatment duration, cycle counts, discontinuation timing and dosing after pregnancy",
      "role": "Required",
      "role_reason": "This condition prevents actual treatment duration for the added exposure from being substituted for the entire pregnancy follow-up period.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish the maximum 6-month plan from actual treatment duration, ovulatory cycle counts, discontinuation and exposure after pregnancy confirmation.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Distinguish the treatment calendar from pregnancy follow-up and examine actual exposure duration and discontinuation pathways."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are the length, end and completeness of pregnancy follow-up for live-birth ascertainment established?",
      "needed": "Arm-specific pregnancy/birth follow-up schedules, last contact, follow-up end and completeness",
      "role": "Required",
      "role_reason": "The observation window needed to obtain birth outcomes in the add-on comparison may differ from the treatment duration.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish treatment end from follow-up after pregnancy through birth and establish arm-specific follow-up start, end and completeness.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare the observation window from pregnancy onset to birth confirmation with incomplete follow-up."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are the event definition, cumulative method and measurement unit of cumulative live birth sufficiently established?",
      "needed": "Endpoint definition, birth-verification procedures, cycle-accumulation rules and handling of multiple/repeated births",
      "role": "Required",
      "role_reason": "Ovulation, pregnancy or infant counts must not be substituted for cumulative live birth per woman in the add-on comparison.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish the cumulative-live-birth label, gestational-age criteria, woman/infant unit, accumulation across cycles, multiple-birth handling and verification procedures.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Obtain endpoint specifications to examine consistency of woman, cycle and infant units with cumulative counting."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are the original reported rates of 34% versus 36% correctly attributed to the add-on comparison?",
      "needed": "Attribution records linking each arm’s reported rate, name, original statement and result location",
      "role": "Required",
      "role_reason": "This condition preserves the observation for the add-on comparison without confusing the reported rates of the three arms.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Link combination 34% and letrozole 36% to the selected comparison, while retaining berberine monotherapy 22% as original context.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When new reports are obtained, first verify arm names for the same endpoint, denominator and time, then compare with existing attribution."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are randomized, analyzed, completed and endpoint-observed denominators established for the two selected arms?",
      "needed": "CONSORT counts, analysis populations, birth-endpoint denominators and missing-data flow for the two selected arms",
      "role": "Required",
      "role_reason": "The combination and shared-control denominators must not be replaced by the overall 644 participants or by 644/3.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish the overall 644-participant allocation description from each selected arm’s randomized, analyzed, completed and endpoint-observed numbers.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare definitions of each denominator to distinguish overall allocation from the endpoint-analysis population."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are live-birth event counts and person/infant/cycle units established for the two selected arms?",
      "needed": "Original live-birth events, denominators, units and handling of repeated/multiple births",
      "role": "Required",
      "role_reason": "Birth-event counts or numbers of women cannot be generated from the combination arm’s reported percentage alone.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish original event counts and the person/infant/cycle units of their denominators without back-calculating reported rates.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Obtain original result tables to examine the relation between events and person/cycle denominators."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are the estimand, ITT/PP and handling of intercurrent events established for the add-on comparison on the common letrozole background?",
      "needed": "Estimand specifications, ITT/PP populations and plans/results for intercurrent events and missing data",
      "role": "Required",
      "role_reason": "The effect of assignment to added berberine may differ from the effect of actual additional intake.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Define whether the effect concerns the assigned add-on strategy or actual additional intake, and check handling of pregnancy, discontinuation, rescue, missingness and ITT/PP.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "After establishing the estimand and analysis populations, examine how pregnancy, discontinuation and rescue treatment enter the definition."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are the formal estimator, method, P and confidence interval for the selected between-arm effect established?",
      "needed": "Original between-arm effect estimates, model, P, confidence interval, denominator and endpoint time",
      "role": "Required",
      "role_reason": "A comparison of reported combination-arm rates must be distinguished from the precision of a formal add-on effect estimate.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish original estimates, uncertainty, denominator and time from an appropriate unadjusted or adjusted between-arm model.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original analysis tables and the SAP to establish comparison estimates and precision. Do not exclude an unadjusted analysis solely because it is unadjusted."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are clinical importance and interpretation criteria for superiority, noninferiority or equivalence established for the selected comparison?",
      "needed": "Hypotheses, clinical-importance/noninferiority margins, effect confidence intervals and interpretation plans",
      "role": "Required",
      "role_reason": "The historical statement of no additional benefit differs from establishing an add-on effect of 0 or equivalence.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Compare prespecified hypotheses and clinical-importance criteria with the corresponding confidence interval; do not convert nonsignificance or original no-benefit wording into equivalence.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Establish original hypotheses and margins, then examine how confidence intervals address clinically important differences."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are losses, missing data, incomplete birth follow-up and the effects of their handling established for the selected arms?",
      "needed": "Arm-specific losses, missing/incomplete pregnancy or birth follow-up, reasons, handling and sensitivity material",
      "role": "Required",
      "role_reason": "The add-on strategy’s reported rate may also be affected by the handling of women who were not followed up.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish arm-specific missing data, reasons for loss, unconfirmed births, analysis handling and sensitivity analyses.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine consistency between missing-data flow and planned handling and establish the scope of original sensitivity analyses."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Is consistency of preregistration, protocol and SAP with actual reporting established for the selected comparison?",
      "needed": "Actual ChiCTR/WHO registration versions, change histories, protocol, SAP and original result tables",
      "role": "Required",
      "role_reason": "Establishing whether the add-on comparison was a prior question and analysis requires more than a registration number.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Use the ChiCTR identifier as a lead to compare actual registration versions, timing, selected arms, endpoints and analysis plans with the original report.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If registration and SAP are obtained, compare registration timing, hypotheses, arms, endpoints and analyses with reporting."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are multiplicity handling and hypothesis hierarchy established for the two derived comparisons in the 3-arm trial?",
      "needed": "3-arm hypothesis hierarchy, multiplicity handling, comparison-specific SAP and reported results",
      "role": "Required",
      "role_reason": "Splitting a 3-arm trial into two sheets does not remove the need to establish the hypothesis hierarchy of the add-on comparison.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish prespecified hierarchy and multiplicity handling for the monotherapy/add-on comparisons and examine reporting selection.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare the original SAP with complete results to examine comparison selection and multiplicity handling."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are both the lack of added benefit with the combination and the unfavorable direction for monotherapy retained?",
      "needed": "Preservation records of original results, counterviews, original assessment, axes and correction history",
      "role": "Required",
      "role_reason": "The original statement of no added benefit must not be overwritten by metabolic possibilities or the monotherapy result.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Retain all three-arm rates, original conclusions, D 34 and all axes without alteration rather than selecting favorable results only.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If subsequent reports become available, compare favorable, unfavorable and no-benefit material under the same attribution rules and record changes as separate events."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are the ChiCTR link, exclusion of the wrong NCT and original unverified registration-field wording kept distinct?",
      "needed": "Linked records of PMID, DOI, ChiCTR, excluded NCT and the original registration field",
      "role": "Required",
      "role_reason": "This record condition prevents the add-on trial’s identity from being replaced with an incorrect registration for another trial.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish ChiCTR-TRC-09000376/PMID/DOI from the excluded NCT01116167 and retain the original registration field’s “not established” wording.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If actual registration material is obtained, compare identifiers, population, 3 arms and endpoints and record discrepancies as separate correction events."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Is it explicit that the two derived sheets concern the same 3-arm trial and shared letrozole arm?",
      "needed": "Relationship records linking one study family, two comparisons, the shared control and report identifiers",
      "role": "Required",
      "role_reason": "Even when the add-on and monotherapy comparisons are presented as separate questions, the control arm of one study must not be counted twice.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Group the same PMID/DOI/ChiCTR into one study family and do not add the two sheets/shared control as independent trials or independent participants.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare report populations, recruitment and identifiers to link the same family and duplicated controls."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are independent replication of the same question and the scope of access established?",
      "needed": "Identities, reports, search scope and original material for independently recruited studies",
      "role": "Required",
      "role_reason": "Replication of the add-on comparison is not obtained by splitting the same 3-arm report into two sheets.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Establish separately recruited studies of the same population, exposure, comparator and live-birth endpoint and the actual reading/search scope.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If new-material review is authorized, assess question-specific eligibility and compare independent recruitment and report overlap."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Is there an applicable set for examining heterogeneity between distinct independent trials in the current retained material?",
      "needed": "Differences in populations, interventions, endpoints and analyses if additional independent families are established",
      "role": "Supplementary; required when synthesizing multiple independent study families",
      "role_reason": "The single family retained for the add-on comparison must not be synthesized as multiple independent trials.",
      "application_exception": "With only one family in the current retained set, between-trial heterogeneity is not applicable. Differences between comparisons within the study and dependence from the shared control remain subject to examination.",
      "criterion": "Do not treat two comparisons in the same study family as between-trial heterogeneity; examine differences between trials when another eligible family is established.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If a separate family is obtained, compare question matching and design, population and estimator differences to examine whether synthesis is appropriate."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are additional dose-response, long-term and subgroup effects beyond the tested dose and duration established?",
      "needed": "Direct comparisons and interaction data for additional doses, durations, products and subgroups",
      "role": "Supplementary; required when extending to other doses, durations or subgroups",
      "role_reason": "A trial adding 1.5 g/day must not be extended to added effects at every dose, formulation or long-term exposure.",
      "application_exception": "The narrow selected comparison does not always require evidence for every dose. Direct evidence is needed only for the extension being considered.",
      "criterion": "Establish extensions beyond actual trial dose, duration and population using direct material and prespecified subgroup/interaction evidence.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When an extension question is needed, review its material as a separate question; do not read simple subgroup differences as interactions."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Is the boundary between live birth and ovulation, pregnancy, metabolic or weight outcomes maintained?",
      "needed": "Records of endpoint hierarchy and attribution boundaries for other outcomes",
      "role": "Required",
      "role_reason": "The combination arm’s birth outcome must not be replaced with another intermediate endpoint.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Fix the selected comparison to cumulative live birth; do not replace it with possible effects on ovulation, pregnancy rates, insulin or weight.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If material on other outcomes is obtained, review those questions separately and interpret their relationship to live birth only where direct linking evidence exists."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are funding, product support, author relationships and conflicts specifically established?",
      "needed": "Funding bodies, research funding, berberine/letrozole supply, author relationships and conflict declarations",
      "role": "Required",
      "role_reason": "Funding and product influence on the add-on result must also be examined using the actual support provided to each arm.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish the public-research-network description from actual supporting institutions, product supply, author relationships and conflict declarations.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original support and conflict statements to establish research funding, product provision and author relationships separately."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are actual maternal, pregnancy and fetal/neonatal harm collection and results established for the selected comparison?",
      "needed": "Arm-specific maternal/pregnancy/fetal/neonatal harm definitions, active collection, event/person denominators, timing, exposure, discontinuation and concomitant-treatment material",
      "role": "Supplementary; required when explaining pregnancy safety or personal-use decisions",
      "role_reason": "Separate harm information is needed because the live-birth add-on comparison alone cannot establish safety during pregnancy.",
      "application_exception": "The principal question concerns live-birth efficacy. Harm incidence is not imposed as an efficacy condition, while safety explanation and personal application require separate direct material.",
      "criterion": "Establish arm-specific harm definitions, collection methods, exposure/follow-up timing, event/person denominators, discontinuations, concomitant treatment and actual results.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If original safety material is obtained, compare harm definitions, collection, follow-up, denominators and discontinuation/concomitant treatment to distinguish signals from comparative risks."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are historical warnings, actual trial harms and personal-use decisions kept distinct?",
      "needed": "Records distinguishing the roles of original safety warnings and actual event material",
      "role": "Required",
      "role_reason": "The roles of the add-on strategy’s live-birth result and the original pregnancy warning must be distinguished.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Retain original warnings without promoting them to actual risk estimates, established causation, long-term safety or new personal dosing instructions.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If original safety material is added, establish the warning’s basis, population and events and examine these separately from comparative risk."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are the original review date, correction date, current sheet-review date and search/reading limits distinguished?",
      "needed": "Original review date, correction date, current review date, search scope and actual access records",
      "role": "Required",
      "role_reason": "The currency of the add-on comparison cannot be established by changing the original review date into a new search date.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Retain original review and correction dates, do not infer absent cutoff/individual access dates, and distinguish whether current new searches or external reading occurred.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When new evidence updating is authorized, record search dates, scope and access events as new records without backdating historical dates."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Are English correction history, remaining generic wording and original null/empty values retained?",
      "needed": "Preservation records of original corrections, bilingual fields, empty values, absent fields and types",
      "role": "Required",
      "role_reason": "Generic English wording must not be read as new denominator, CI or funding facts in the add-on comparison either.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Do not fill the 1 correction or remaining generic verification wording with specific clinical values; retain empty detailed-claim lists/review notes, original axes and original types.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If a new bilingual correction is needed, establish corresponding original values and the correction event and preserve the entire text before change."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Are current retained-summary reading, unread external materials and historical matching statements separated by material type?",
      "needed": "Material-specific current acquisition/reading, URL, version, historical access date/level and original-location records",
      "role": "Required",
      "role_reason": "Reading the add-on comparison’s summary must not be represented as rereading the paper’s full text.",
      "application_exception": "This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.",
      "criterion": "Distinguish actual reading of retained summaries from current unattempted/unread PubMed, DOI, paper, registration and SAP materials; do not inherit access levels/dates from a containing document.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If external material is actually obtained, verify its own access event, version and original locations and update only the current reading record."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Are joint-estimation and dependence-handling materials established for the two comparisons using the shared letrozole arm?",
      "needed": "Joint-estimation, covariance and multiplicity/SAP material accounting for the shared control",
      "role": "Supplementary; required when synthesizing or making joint comparative claims about the two comparisons",
      "role_reason": "The add-on and monotherapy comparisons are linked through one study’s shared control, so their two effects cannot be pooled as independent observations.",
      "application_exception": "A joint synthesis model is not always required to describe this add-on comparison alone. Joint synthesis or relative interpretation of the two comparisons requires material accounting for dependence from the shared arm.",
      "criterion": "Check the original analysis for joint-estimation, covariance, shared-control handling and multiplicity specifications for the two comparisons.",
      "basis": "Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern cumulative live birth with berberine added to common letrozole versus letrozole alone and were developed with knowledge of the retained content. They were frozen before application; this does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If joint interpretation is needed, compare the original SAP and comparison-specific estimates and establish a method accounting for shared-control dependence. Do not pool the effects in the two sheets as independent."
    }
  ]
}