{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2969-s0", "verdict_number": "2969", "title": "Intravenous tranexamic acid × Improved 90-day functional status in spontaneous intracerebral hemorrhage", "view_version": "1.0", "view_created_date": "2026-10-13", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "TICH-2 population with acute spontaneous intracerebral hemorrhage within eight hours of onset. Original exclusions such as anticoagulation, trauma and structural-lesion causes are preserved. Twelve countries, 124 hospitals, 2,325 randomized participants (1,161/1,164) and 90-day mRS observed in 2,307/2,325 (99.2%) are recorded as separate original denominators. Recruitment, group-specific missingness and missing-data assumptions remain unverified.", "intervention": "The original study exposure of intravenous tranexamic acid, 2 g total within eight hours of onset, is preserved. Results from other indications such as trauma/postpartum hemorrhage are not transferred to this functional question, and administration/treatment procedures are not created.", "dose": "The original study conditions of 2 g within eight hours are distinguished from actual individual administration, timing and adherence. Original detailed administration/discontinuation and time/dose subgroup materials remain unverified; no new conversion or administration guidance is created.", "comparator": "Active drug versus saline placebo in identical packaging. Historical original descriptions of central allocation, country stratification/minimization on prognostic factors, role-specific concealment/masking and ITT are preserved without inheriting them as original-procedure verification. Concurrent treatment, actual individual exposure and analysis details remain unverified.", "endpoint": "Selected question: improved 90-day functional status. TICH-2’s mRS 0–6, lower-is-better distribution-shift adjusted OR 0.88 (95% CI 0.76–1.03), P=.11 is preserved. Death/dependence sensitivity analysis, 24-hour hematoma expansion and seven-day death signals are separate results. The 2026 IPD meta-analysis reports 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), a separate estimand with an unspecified threshold; it is not used as a recalculation of the same distribution shift.", "duration": "TICH-2’s prespecified 90-day functional status is separated from early 24-hour/seven-day outcomes. Actual individual assessment windows, later function and long-term results remain unverified. The IPD meta-analysis’s 90-day outcome and early seven-day death adjusted OR 0.70 also remain within separate original-report scopes.", "excluded_extensions": [ "Mixing TICH-2 mRS distribution shift with IPD meta-analysis poor-function thresholds/estimands/denominators, or creating new effects/CI", "Promoting 24-hour hematoma expansion/seven-day death to 90-day functional efficacy", "Changing death/dependence sensitivity or nonsignificance to certification of equivalence, zero effect or exclusion of all important benefits", "Summing meta-analysis nine trials/3,194, IPD five trials/2,860 and TICH-2, reports, groups, timepoints or sibling sheets as new independent trials/participants", "Inheriting original R1, author overlap or historical cross-validation as new independence certification", "Changing bias-risk wording preserved in the meta-analysis funding field to funding verification, or changing the registration-identifier record’s Not applicable to verified absence of registration/plans", "Transferring results to other indications/formulations, periods or populations", "Inheriting parent score/axes or historical narratives as subclaim score, current review or original-text reading", "New calculations, invented values, effects/CI, grades, independence certification or medication/antisepsis/surgery/treatment implementation guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected 90-day functional question and original values", "needed": "Distinguish the existing grade/note from the parent score/axes", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the existing grade/note from the parent score/axes and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the existing grade/note from the parent score/axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying the functional endpoint/timepoint; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected subclaim is ‘Improved 90-day functional status’, graded D with a note that the prespecified primary endpoint was null at P=.11. Subclaim score/status/axes are absent; the parent D34 is not used to fill a subclaim score.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score/status/axes are absent; early imaging/death results are not transferred to functional improvement. Existing content review remains incomplete.", "missingness": "Subclaim score/status/axes are absent; early imaging/death results are not transferred to functional improvement.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected/parent records and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Spontaneous intracerebral hemorrhage and population", "needed": "Actual scope of acuity/cause, eligibility and baseline risk", "role": "Required", "role_reason": "Applicability item distinguishing actual scope of acuity/cause, eligibility and baseline risk and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for actual scope of acuity/cause, eligibility and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up comparative research specifying the population/indication; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original scope is acute spontaneous intracerebral hemorrhage not caused by anticoagulation, trauma or structural lesions. Established benefits in trauma/postpartum hemorrhage or other causes are not transferred to the selected functional result.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed eligibility, age/baseline severity, recruitment, exclusions and between-group balance remain unverified. Existing content review remains incomplete.", "missingness": "Detailed eligibility, age/baseline severity, recruitment, exclusions and between-group balance remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/recruitment, baseline characteristics and definitions of cause" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Intravenous 2 g within eight hours: research exposure", "needed": "Distinguish the original drug/route/timing from actual exposure", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the original drug/route/timing from actual exposure and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the original drug/route/timing from actual exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing route/timing and population specifications; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Only the research exposure of intravenous tranexamic acid 2 g within eight hours of acute hemorrhage is preserved. No administration/selection procedure, timing-specific effect or instructions for other doses/routes are created.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Actual administration/onset times, product/batch, exposure/discontinuation and timing-specific analyses remain unverified. Existing content review remains incomplete.", "missingness": "Actual administration/onset times, product/batch, exposure/discontinuation and timing-specific analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Drug/product, onset/administration and actual-exposure materials" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Identical packs and saline comparator", "needed": "Trial-drug/placebo preparation, support, sensory characteristics and contact specifications", "role": "Required", "role_reason": "Applicability item distinguishing trial-drug/placebo preparation, support, sensory characteristics and contact specifications and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for trial-drug/placebo preparation, support, sensory characteristics and contact specifications should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research disclosing the actual comparator and preparation/support roles; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that Sharp Clinical Services prepared active drug/saline placebo in identical packs at trial expense. This is not changed to donated product support or confirmation of all contact/masking maintenance.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original preparation/product, payment, concurrent treatment/contact, masking maintenance and role materials remain unread. Existing content review remains incomplete.", "missingness": "Original preparation/product, payment, concurrent treatment/contact, masking maintenance and role materials remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preparation/product agreements, contact and masking materials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Central allocation, minimization and concealment", "needed": "Historical allocation procedures and scope of actual original-material access", "role": "Required", "role_reason": "Applicability item distinguishing historical allocation procedures and scope of actual original-material access and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for historical allocation procedures and scope of actual original-material access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trials disclosing allocation procedures; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records real-time central allocation through a secure website, country stratification, minimization on prognostic factors and allocation concealment. This is not upgraded to current certification of procedures/allocation records.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original variables, sequence/implementation, exceptions, baseline balance and protocol remain unread. Existing content review remains incomplete.", "missingness": "Original variables, sequence/implementation, exceptions, baseline balance and protocol remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation/minimization, baseline and protocol materials" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Masking and 90-day collection", "needed": "Masking scope for participants, assessment, clinical care and mRS collection", "role": "Required", "role_reason": "Applicability item distinguishing masking scope for participants, assessment, clinical care and mRS collection and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for masking scope for participants, assessment, clinical care and mRS collection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research specifying masking of measurement/adjudication; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original description of concealment from patients/assessors/clinical staff and masked collection of 90-day mRS is preserved. This does not declare current original-material reading, masking-maintenance or expectation-effect verification.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original roles, maintenance/unmasking, actual collection methods and assessor training/adjudication details remain unread. Existing content review remains incomplete.", "missingness": "Original roles, maintenance/unmasking, actual collection methods and assessor training/adjudication details remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original masking and mRS collection/adjudication materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "mRS 0–6, direction and distribution", "needed": "Scale definitions and distinction of distribution shift from means/thresholds", "role": "Required", "role_reason": "Applicability item distinguishing scale definitions and distinction of distribution shift from means/thresholds and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for scale definitions and distinction of distribution shift from means/thresholds should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4; internal extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying differences between distributions, thresholds and importance; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "mRS ranges from 0, no symptoms, to 6, death, with lower scores better; the TICH-2 endpoint is distribution shift at 90 days. This is not changed to a mean score, specific threshold or survival-only result.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Category-specific distributions, adjudication/collection, model categories/direction and clinical importance remain unverified. Existing content review remains incomplete.", "missingness": "Category-specific distributions, adjudication/collection, model categories/direction and clinical importance remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "mRS category distributions, collection/adjudication and model definitions" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "90 days and actual assessment window", "needed": "Distinguish the original timepoint from assessment/follow-up and other periods", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the original timepoint from assessment/follow-up and other periods and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the original timepoint from assessment/follow-up and other periods should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating timepoints, function and survival outcomes; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The prespecified primary endpoint is modified Rankin functional status at 90 days. Seven-day death, 24-hour hematoma expansion and long-term functional/daily-life outcomes are not combined as the same timepoint/endpoint.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Assessment windows, individual follow-up, period-specific missingness and later function/survival remain unverified. Existing content review remains incomplete.", "missingness": "Assessment windows, individual follow-up, period-specific missingness and later function/survival remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Assessment/follow-up and timepoint-specific functional/missingness materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "TICH-2 adjusted OR, CI and P", "needed": "Distinguish the original shift estimand from new effects/proportions", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the original shift estimand from new effects/proportions and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the original shift estimand from new effects/proportions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research disclosing the original estimand/precision; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Adjusted OR 0.88 (95% CI 0.76–1.03), P=.11 is preserved. No new between-group difference, RR, mean score, CI or individual response proportion is calculated.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original model/covariates, proportional-odds/category handling, exact distributions and sensitivity analyses remain unread. Existing content review remains incomplete.", "missingness": "Original model/covariates, proportional-odds/category handling, exact distributions and sensitivity analyses remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Distribution/adjusted-model, CI and original-result materials" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "CI, meaningful benefits and the null result", "needed": "Scope of nonsignificance versus importance/equivalence", "role": "Required", "role_reason": "Applicability item distinguishing scope of nonsignificance versus importance/equivalence and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for scope of nonsignificance versus importance/equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing effects/importance and question scope; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that no minimum clinically important between-group difference was declared, so the CI cannot be said to exclude all meaningful benefits. A null result is not newly certified as exactly zero effect, equivalence or no effect in every population.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and a sufficient range for the exact effect remain unverified. Existing content review remains incomplete.", "missingness": "Prespecified importance/success/equivalence criteria and a sufficient range for the exact effect remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified criteria, estimand/CI and clinical-importance materials" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "2,325 participants, countries/hospitals and denominators", "needed": "Randomized population versus 90-day observation and multicenter/group units", "role": "Required", "role_reason": "Applicability item distinguishing randomized population versus 90-day observation and multicenter/group units and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for randomized population versus 90-day observation and multicenter/group units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing recruitment, observation and analysis units; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Twelve countries, 124 hospitals and 2,325 participants (1,161/1,164) are preserved. Countries/hospitals, groups, timepoints and events are not summed as new independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific 90-day observation/analysis, hospital/country distributions and risk/effective denominators remain unverified. Existing content review remains incomplete.", "missingness": "Group-specific 90-day observation/analysis, hospital/country distributions and risk/effective denominators remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and group/timepoint-specific analysis/observation denominators" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "90-day 2,307/2,325 and 99.2%", "needed": "Distinguish the original availability rate from missingness/analysis populations", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the original availability rate from missingness/analysis populations and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the original availability rate from missingness/analysis populations should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing availability/missingness from estimation populations; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original wording that 90-day mRS was available in 2,307/2,325 participants, 99.2%, is preserved. No new missing counts/proportions are calculated, and this is not changed to complete observation of every endpoint/timepoint.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific missingness/dropout reasons, categories/timepoints, handling/sensitivity and actual analysis denominators remain unverified. Existing content review remains incomplete.", "missingness": "Group-specific missingness/dropout reasons, categories/timepoints, handling/sensitivity and actual analysis denominators remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "mRS flow/missingness, group denominators and handling/sensitivity materials" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "ITT and retaining allocated groups", "needed": "Historical analysis principles and current original-material access scope", "role": "Required", "role_reason": "Applicability item distinguishing historical analysis principles and current original-material access scope and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for historical analysis principles and current original-material access scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately disclosing allocation, observation and actual-exposure analyses; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original description of ITT retaining participants in their minimization-allocated groups is preserved. Actual mRS measurements for everyone, absence of missing-data effects or model details are not stated as verified in this work.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original inclusion/exclusion, missing-data/model and PPS/sensitivity materials remain unread. Existing content review remains incomplete.", "missingness": "Original inclusion/exclusion, missing-data/model and PPS/sensitivity materials remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ITT/inclusion, missing-data/model and sensitivity materials" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Registration, prespecified primary endpoint and combined identifiers", "needed": "Descriptions of prerecruitment registration/endpoint agreement versus full plans", "role": "Required", "role_reason": "Applicability item distinguishing descriptions of prerecruitment registration/endpoint agreement versus full plans and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for descriptions of prerecruitment registration/endpoint agreement versus full plans should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research publicly linking prespecified plans with actual analyses; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registration-identifier value in the evidence list is ISRCTN93732214 · EudraCT 2012-004108-37. Historical statements of agreement with the prespecified 90-day mRS and registration before recruitment are preserved; full registration/plan materials remain unread in this work.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration dates/changes, protocol/SAP and full analysis specifications remain unread. Existing content review remains incomplete.", "missingness": "Registration dates/changes, protocol/SAP and full analysis specifications remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both registrations, protocol and SAP" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Early secondary hematoma/death outcomes", "needed": "Hierarchy of 24-hour imaging, seven-day death and 90-day primary function", "role": "Required", "role_reason": "Applicability item distinguishing hierarchy of 24-hour imaging, seven-day death and 90-day primary function and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for hierarchy of 24-hour imaging, seven-day death and 90-day primary function should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M03 §3.2.4; internal extension boundary; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing primary function from early death/imaging outcomes; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Reduced 24-hour hematoma expansion and seven-day death are secondary signals. They are not promoted to successful 90-day functional recovery, a primary endpoint or independent confirmation.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Counts/denominators, CI/P, prespecified hierarchy/multiplicity and measurement/analysis specifications for each secondary outcome remain unverified. Existing content review remains incomplete.", "missingness": "Counts/denominators, CI/P, prespecified hierarchy/multiplicity and measurement/analysis specifications for each secondary outcome remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete timepoint/endpoint-specific results, SAP and imaging/death definitions" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Death/dependence sensitivity analysis", "needed": "Distinguish distribution shift from other definitions/sensitivity analyses", "role": "Required", "role_reason": "Applicability item distinguishing distinguish distribution shift from other definitions/sensitivity analyses and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish distribution shift from other definitions/sensitivity analyses should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately reporting the primary distribution and sensitivity/threshold results; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that the 90-day death-or-dependence sensitivity analysis was also statistically null. No specific mRS threshold, exact effect or CI is newly filled, and other functional outcomes are not treated as the same result.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Death/dependence definitions, threshold, denominators/estimates/CI and model remain unverified. Existing content review remains incomplete.", "missingness": "Death/dependence definitions, threshold, denominators/estimates/CI and model remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sensitivity definitions/models and original results/CI" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "IPD meta-analysis: poor function and OR", "needed": "Distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution", "role": "Required", "role_reason": "Applicability item distinguishing distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up evidence synthesis distinguishing functional definitions/estimands; no new search, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S02 originally records null 90-day poor function: 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07). This does not replace TICH-2’s distribution OR 0.88 as the same original result or a newly pooled value.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Poor-function threshold/definition, distribution/common-OR model, proportion denominators and time/exposure correspondence remain unverified. Existing content review remains incomplete.", "missingness": "Poor-function threshold/definition, distribution/common-OR model, proportion denominators and time/exposure correspondence remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Meta-analysis/trial definitions and model/estimand/denominator materials" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Nine trials/3,194 and IPD from five/2,860", "needed": "Distinguish reported aggregates/individual data from unique participants/overlap", "role": "Required", "role_reason": "Applicability item distinguishing distinguish reported aggregates/individual data from unique participants/overlap and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish reported aggregates/individual data from unique participants/overlap should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately disclosing inclusion, acquisition, overlap and denominators; no new search, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original meta-analysis counts are nine trials/3,194 participants, with IPD supplied by five trials/2,860 participants (90%). These are not added to TICH-2, and remaining counts/proportions or new effects are not calculated.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial lists/cohort correspondence, missing IPD/variable-specific denominators, duplication/weighting and data acquisition remain unread. Existing content review remains incomplete.", "missingness": "Included-trial lists/cohort correspondence, missing IPD/variable-specific denominators, duplication/weighting and data acquisition remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Included trials/data acquisition, variable-specific denominators and pooling models" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Meta-analysis early death and imaging", "needed": "Separate meta-analysis results for 90-day function versus seven-day death/hematoma", "role": "Required", "role_reason": "Applicability item distinguishing separate meta-analysis results for 90-day function versus seven-day death/hematoma and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for separate meta-analysis results for 90-day function versus seven-day death/hematoma should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately synthesizing early and long-term endpoints; no new search, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original meta-analysis record states significant reductions in seven-day death/hematoma expansion and an adjusted OR of 0.70 for seven-day death. These are not used as success for the selected 90-day functional question or as the same estimand.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/denominators/CI/P, multiplicity/plans and trial-specific correspondence for each early outcome remain unverified. Existing content review remains incomplete.", "missingness": "Definitions/denominators/CI/P, multiplicity/plans and trial-specific correspondence for each early outcome remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original meta-analysis timepoint/endpoint-specific results and plans/CI" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Meta-analysis/authors, original R1 and independence", "needed": "Synthesis reports versus unique trials, endpoint hierarchy and author relationships", "role": "Required", "role_reason": "Applicability item distinguishing synthesis reports versus unique trials, endpoint hierarchy and author relationships and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for synthesis reports versus unique trials, endpoint hierarchy and author relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up independent comparative research with the same functional specifications; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Because meta-analysis authors overlapped with TICH-2 investigators and 90-day mRS was not primary in component trials, the original verdict did not count independent replication and retained R1. The same trials, references, follow-up or synthesis reports are not used as new independent-trial/participant totals.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial/author/endpoint correspondence, unique clinical totals and independent replication are not newly established. Existing content review remains incomplete.", "missingness": "Included-trial/author/endpoint correspondence, unique clinical totals and independent replication are not newly established.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Included-trial/report/author and endpoint/cohort relationships" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Meta-analysis funding and registration: preserved records", "needed": "Distinguish original fields from funding/registration verification", "role": "Required", "role_reason": "Applicability item distinguishing distinguish original fields from funding/registration verification and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish original fields from funding/registration verification should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research disclosing synthesis plans, support and assessment scope; no new search, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S02’s funding field preserves ‘All included trials were at low risk of bias’, and its registration-identifier value is ‘Not applicable’. These are not used as verification of actual funding/no registration or as current bias assessment of individual trials.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original synthesis-report funding/COI, review registration/protocol and bias-domain/assessment materials remain unread. Existing content review remains incomplete.", "missingness": "Original synthesis-report funding/COI, review registration/protocol and bias-domain/assessment materials remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Meta-analysis funding/COI, registration/protocol and assessment materials" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Concurrent treatment and timing/group analyses", "needed": "Distinguish the study drug from concurrent acute treatment/exposure", "role": "Required", "role_reason": "Applicability item distinguishing distinguish the study drug from concurrent acute treatment/exposure and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish the study drug from concurrent acute treatment/exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing concurrent treatment from study exposure; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original scope is a placebo comparison in acute spontaneous intracerebral hemorrhage within eight hours. Absence of effects from other treatments/lifestyle, actual exposure or timing/subgroups is not verified.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the preserved summary. Concurrent treatments/drugs, procedures, group-specific contact/timing, subgroups/interactions and analyses remain unverified. Existing content review remains incomplete.", "missingness": "Concurrent treatments/drugs, procedures, group-specific contact/timing, subgroups/interactions and analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent-exposure/treatment and period/subgroup-analysis materials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "NIHR/Swiss support and trial sponsor", "needed": "Support organizations and the University of Nottingham’s role", "role": "Required", "role_reason": "Applicability item distinguishing support organizations and the University of Nottingham’s role and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for support organizations and the University of Nottingham’s role should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately disclosing support and research roles; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states support from the NIHR HTA Programme and Swiss Heart Foundation, with Nottingham as trial sponsor. Public/foundation funding does not newly certify absence of all relationships/roles or independence.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original funding/sponsorship agreements, data/analysis/publication rights and author COI remain unread. Existing content review remains incomplete.", "missingness": "Original funding/sponsorship agreements, data/analysis/publication rights and author COI remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding/sponsor, role and COI disclosures" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Preparation expense and pharmaceutical/analysis/writing support", "needed": "Trial-expense preparation versus donated support/unreported items", "role": "Required", "role_reason": "Applicability item distinguishing trial-expense preparation versus donated support/unreported items and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for trial-expense preparation versus donated support/unreported items should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing support items from preparation/research roles; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that Sharp prepared identical packs at trial expense and no pharmaceutical donation, analysis, medical writing or publication funding was reported. Unreported items are not judged actually absent.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original agreements/provision, support-specific roles, author relationships and external analysis/writing materials remain unread. Existing content review remains incomplete.", "missingness": "Original agreements/provision, support-specific roles, author relationships and external analysis/writing materials remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preparation/product and analysis/writing/publication-support disclosures" }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Seizures, thrombosis and serious adverse events", "needed": "Distinguish separate safety endpoints/denominators from functional efficacy", "role": "Supplementary", "role_reason": "Applicability item distinguishing distinguish separate safety endpoints/denominators from functional efficacy and connecting materials needed for the selected question with current materials.", "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.", "criterion": "Corresponding original materials and analysis scope for distinguish separate safety endpoints/denominators from functional efficacy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separating harms from functional efficacy; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states seizures in 77 (7%) vs 85 (7%), no increase in venous thromboembolism and fewer serious adverse events through 90 days. These are not used as success on primary function or absence of all harms.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/collection, group denominators/frequencies, relatedness/severity, effects/CI and long-term harms for each adverse outcome remain unverified. Existing content review remains incomplete.", "missingness": "Definitions/collection, group denominators/frequencies, relatedness/severity, effects/CI and long-term harms for each adverse outcome remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event/thrombosis/seizure and denominator/follow-up/CI materials" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Other indications/periods and generalization", "needed": "Original spontaneous hemorrhage/route/timing versus separate effects", "role": "Required", "role_reason": "Applicability item distinguishing original spontaneous hemorrhage/route/timing versus separate effects and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original spontaneous hemorrhage/route/timing versus separate effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; M03 §3.2.4; internal extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing directness across indications/periods; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved summary states that benefits in trauma/postpartum hemorrhage concern separate indications. This is not extended to other causes/doses/routes, emergency treatment/procedural guidance or long-term functional effects.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct functional comparisons under other specifications and later persistence/long-term harms remain unverified. Existing content review remains incomplete.", "missingness": "Direct functional comparisons under other specifications and later persistence/long-term harms remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct trials/follow-up by population, route and timing" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Original axes, Korean/English text, dates and corrections", "needed": "Distinguish parent/subclaim values, verdict date/meta-analysis year and history", "role": "Required", "role_reason": "Applicability item distinguishing distinguish parent/subclaim values, verdict date/meta-analysis year and history and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinguish parent/subclaim values, verdict date/meta-analysis year and history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing original values/history from the scope of update materials; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent D34, B/P/R1/I2/E0/B0/C0, three false markers, empty override reasons and subclaim grade D are preserved. The summary’s 2026 meta-analysis label, 2026-08-26 date, Korean/English manuscripts, empty corrections/deliberation and cross-validation are not inherited as a current latest search or review in this work.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled from parent values; original dates/history are not changed. Existing content review remains incomplete.", "missingness": "Absent subclaim score/status/axes are not filled from parent values; original dates/history are not changed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Corrections/versions and user correction comments" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Actual summary reading, links and gaps", "needed": "Preserved summary versus external trial/meta-analysis/registration/plan access", "role": "Required", "role_reason": "Applicability item distinguishing preserved summary versus external trial/meta-analysis/registration/plan access and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for preserved summary versus external trial/meta-analysis/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research updating records with actual acquisition, timing and scope distinguished; no new search, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete preserved summary and references were used for production, and links are retained. External TICH-2/meta-analysis, registration, protocol/SAP and support/COI originals remain unread, with no access attempted or separate external-link testing.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External contents, included-trial correspondence and actual acquisition/accessibility remain unverified. Existing content review remains incomplete.", "missingness": "External contents, included-trial correspondence and actual acquisition/accessibility remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External original papers, registration, protocol/SAP and support materials, or user comments" } ], "reports": [ { "report_id": "S01", "title": "Sprigg N et al. 2018 TICH-2", "url": "https://pubmed.ncbi.nlm.nih.gov/29778325/", "report_type": "International multicenter double-blind randomized placebo-controlled phase 3 trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2969-TICH-2", "independent_replication": null, "observed_result": "Adjusted OR 0.88 (95% CI 0.76–1.03), P=0.11; graded D. In TICH-2’s 2,325 participants, adjusted OR for 90-day mRS distribution shift was 0.88 (95% CI 0.76–1.03), P=0.11, a null result. The individual-patient-data meta-analysis described as latest in the preserved manuscript also had a null 90-day poor-functional-outcome result: 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07). The manuscript records the same conclusion across the randomized evidence available to it, beyond TICH-2 alone.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29778325/" } ] }, { "report_id": "S02", "title": "2026 individual-patient-data meta-analysis of tranexamic acid", "url": "https://pubmed.ncbi.nlm.nih.gov/42276775/", "report_type": "Systematic review and individual-patient-data meta-analysis of randomized trials in acute spontaneous intracerebral hemorrhage", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "SYN2969-IPD-META-2026", "independent_replication": null, "observed_result": "At 90 days, 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07); significant reductions in seven-day death and hematoma expansion (adjusted OR 0.70 for seven-day death). The original funding-field wording All included trials were at low risk of bias does not identify a funder, and the original registration-identifier record’s Not applicable does not verify absence of a synthesis plan/registration.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/42276775/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 TICH-2 reports randomization of 2,325 participants (1,161/1,164) with spontaneous intracerebral hemorrhage across 124 hospitals in 12 countries. Observed 90-day mRS in 2,307/2,325 (99.2%) and mRS distribution-shift OR 0.88 (95% CI 0.76–1.03)/P=.11 are preserved and distinguished from 24-hour hematoma expansion, seven-day death and death/dependence sensitivity analysis. Participants, groups, timepoints, early endpoints, the same references and sibling sheets are not summed as new independent trials/participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed. S02 is the preserved 2026 systematic-review/IPD-meta-analysis report. Nine trials/3,194 participants overall, IPD from five trials/2,860 participants (90%), and 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), are recorded as separate synthesis results. Component-trial lists/IPD correspondence, detailed TICH-2 inclusion relationships and thresholds remain externally unread. The manuscript’s overall evidence relationships, TICH-2 author overlap and original R1 judgment are preserved as history; current independence is not certified. Early seven-day death OR 0.70 and hematoma results are not changed to primary functional results. This synthesis is not turned into a new independent RCT or nine new reports, or added to TICH-2 participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed." }, "history": [ { "date": "2026-10-13", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-13" }