{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3115-main", "verdict_number": "3115", "title": "Vitamin C (L-ascorbic acid) × Isotope-measured fractional iron absorption in nonanemic women with low iron stores", "view_version": "1.0", "view_created_date": "2026-11-06", "criteria_version": "NGM-v3115-LOW-STORES-NONANEMIC-FIA-1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-16", "review_scope": { "materials_read": "Stored Korean and English manuscripts and case-specific criteria and application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "No external clinical abstracts, full texts, registrations or analysis plans were newly read. Reading the stored summaries is distinguished from not having read the external original materials, and the original assessment, numerical values and unverified information are preserved. No new searches, calculations or reassessments were performed.", "date_meaning": "This is the date the stored materials were checked, not the date of an up-to-date clinical literature search." }, "claim_context": { "population": "Nonpregnant, nonlactating women aged 18–45 years; ferritin ≤30 μg/L, Hb >12 g/dL, CRP <5 mg/L; BMI 18.5–26.5 kg/m², body weight <70 kg; no major chronic disease.", "intervention": "Addition of 80 mg of single-ingredient, food-grade L-ascorbic acid to the same fasted oral iron exposure", "dose": "Ascorbic acid 80 mg + elemental iron 100 mg in a ferrous fumarate capsule + the reported isotope label 3 mg; author-reported ascorbic acid:iron molar ratio 0.24:1.", "comparator": "The same participant takes the same labeled ferrous fumarate capsule with 200 mL of water at 07:00–09:00 in the morning after an overnight fast, without added ascorbic acid.", "endpoint": "Stable-isotope-derived fractional iron absorption (%); a model assuming 80% erythrocyte incorporation, distinct from hemoglobin or ferritin recovery.", "duration": "Exposure 1 time per condition; crossover dosing days 1,3,5,22,24,26; according to the Methods section, isotope incorporation measured 17–21 days after each dose, with blood sampling on days 22/43.", "excluded_extensions": "Anemia/Hb recovery, fatigue/vitality, long-term use/optimal dose, juice alone, salts/combination products, other iron formulations, meals, intravenous administration, other populations and individual safety are separate questions." }, "requirements": [ { "item_id": "N01", "question_type": "Independent question", "question": "Which iron absorption comparison does this table address?", "needed": "Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption", "role": "Required", "role_reason": "Needed to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification.", "application_exception": "The subclaims array is empty. No additional main table is created for anemia treatment, Hb recovery, fatigue or long-term health effects.", "criterion": "Preserve the exact /ko/effect and link the scope to the single comparison adding 80 mg to the same fasted iron exposure.", "basis": "C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the original claim, population, exposure, comparator and endpoint to document included/excluded questions and the different Hb endpoint in 907.", "current_reports": [ "S01", "P907" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The original claim is ‘isotope-measured fractional iron absorption in nonanemic women with low iron stores.’ It compares addition of 80 mg of single-ingredient L-ascorbic acid with an identical fasted oral iron-and-water control. Anemia treatment, fatigue, vitality and Hb recovery in 907 are separate questions.", "condition_status": "Met", "status_reason": "The identity of the question and its exclusion boundaries have been linked to the current manuscript. This does not mean that a clinical treatment effect or suitability for an individual's use has been verified.", "missingness": "The boundaries of the independent question have been documented. The exact paired effect and clinical benefit remain unverified in other rows.", "uncertainty": "The boundaries of the independent question have been documented. The exact paired effect and clinical benefit remain unverified in other rows. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption" }, { "item_id": "N02", "question_type": "Main trial identity", "question": "To which article is the main absorption result attributed?", "needed": "Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article", "role": "Required", "role_reason": "Needed to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL.", "application_exception": "Verification of bibliographic agreement does not replace rereading the full text or certification of original-data accuracy.", "criterion": "Link the DOI 10.1002/ajh.26987, PMID 37357807 and main-result locations in S01 and S02 to the same article.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the article identity and citation locations, keeping the roles of other outcomes/cited reports separate.", "current_reports": [ "S01", "S02" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "S01 is the 2023 Am J Hematol article by von Siebenthal and colleagues. The PubMed identity in S02 has the same DOI and PMID. The current main-trial summary is attributed to Methods 2.1–2.5 and Results 3/Figure 2A in S01.", "condition_status": "Met", "status_reason": "The bibliography and attribution of the main-trial summary agree within the current stored summary. The external publisher site and PubMed were not opened this time.", "missingness": "The original article's full text and original tables/figures have not been cross-checked again in the current work.", "uncertainty": "The original article's full text and original tables/figures have not been cross-checked again in the current work. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article" }, { "item_id": "N03", "question_type": "Report family", "question": "Are the 22 bibliographic entries being kept distinct from independent absorption trials?", "needed": "The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907", "role": "Required", "role_reason": "Needed to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications.", "application_exception": "Because sources and trial_families are absent from the current stored summary, no new definitive count of unique families for other cohorts is made.", "criterion": "Identify verified reports belonging to the same family and provisional/unverified links, distinguishing the bibliographic count from the number of direct trials.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / H07: M04 §4.6.1–4.6.2; adaptation for harms material is internally designed. The rationale for application to this case is to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the DOI, registration, population/schedule and included-trial tables across all reports to audit family duplication and unverified relationships.", "current_reports": [ "S01", "S02", "S03", "S17", "P907" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "There are 22 bibliographic entries: S01–S21 and P907. S01/S02/S03 belong to the same article family: main text, index and supplementary material. S17 reflects a historical inference that it is probably the registration for the same trial. The 1 directly eligible family in the original evidence_status reflects the verification scope at that time; other bibliographic entries are not added as independent direct trials.", "condition_status": "Partly verified", "status_reason": "The same-article family and material types have been distinguished. The official link for S17 and the complete identities of unique cohorts in other reports cannot be established from the current input alone.", "missingness": "Official registration linkage and a mapping of unique trials/cohorts in the related articles", "uncertainty": "Official registration linkage and a mapping of unique trials/cohorts in the related articles. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907" }, { "item_id": "N04", "question_type": "Reading scope", "question": "Have materials actually read now been distinguished from full texts read in the past?", "needed": "Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type", "role": "Required", "role_reason": "Needed to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time.", "application_exception": "Preserve the past supplementary-material 403 and failed registration-history access as historical records, without labeling them as current inaccessibility.", "criterion": "Separate reading of the current stored summary from external access not attempted/materials not acquired/not read, and attach only links appropriate to each material type.", "basis": "C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Audit the current input scope and the access/acquisition/reading history by material type, and update separately only when an actual new reading event occurs.", "current_reports": [ "S01", "S03", "S04", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The current retained KO 16 fields, structured evidence, 22 bibliographic entries, assessment and gap/correction records were read. The original assessment records past verification of the full S01 HTML and official index/safety materials. The content referenced in sources.json, the old ZIP and external materials were not opened this time; all external material types remain unread.", "condition_status": "Met", "status_reason": "Actual summary reading has been distinguished from past full-text/partial access and current access not attempted. No new verification of full-text content is claimed.", "missingness": "No current cross-check of external original articles, appendices, registration histories or similar materials has been performed.", "uncertainty": "No current cross-check of external original articles, appendices, registration histories or similar materials has been performed. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type" }, { "item_id": "N05", "question_type": "Selected population", "question": "What were the actual population's iron stores, anemia status and selection criteria?", "needed": "Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow", "role": "Required", "role_reason": "Needed to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations.", "application_exception": "Iron-store criteria alone do not establish vitamin C deficiency, absence of iron overload or representativeness.", "criterion": "Link ferritin ≤30 μg/L, Hb >12 g/dL and the other criteria for the actual nonpregnant, nonlactating women aged 18–45 years to the limits of applicability.", "basis": "C04: M03 §3.2.1; detailed population criteria are internally designed / E01: M08 §8.1–8.2.3; internal application. The rationale for application to this case is to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check inclusion/exclusion criteria, the baseline-characteristics table and recruitment flow to examine the actual analyzed population and scope of generalization.", "current_reports": [ "S01", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The population comprises nonpregnant, nonlactating women aged 18–45 years with ferritin ≤30 μg/L, Hb >12 g/dL and CRP <5 mg/L. The retained criteria also specify BMI 18.5–26.5 kg/m², body weight <70 kg and no major chronic disease. This is not classified as a treatment trial in women with anemia.", "condition_status": "Partly verified", "status_reason": "The claim's population has been linked to the retained selection criteria. Verification against original data remains outstanding for actual baseline distributions, recruitment representativeness and differences from the registration criteria.", "missingness": "Cross-check of baseline characteristics/recruitment distributions and official registration criteria against original data", "uncertainty": "Cross-check of baseline characteristics/recruitment distributions and official registration criteria against original data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow" }, { "item_id": "N06", "question_type": "Baseline nutritional status", "question": "Can this be interpreted as an effect of correcting vitamin C deficiency or of the habitual diet?", "needed": "Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion", "role": "Required", "role_reason": "Needed to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake.", "application_exception": "Tests retained as not reported are not filled in as normal values or deficiency.", "criterion": "Identify the actual reporting scope for baseline vitamin C status, habitual diet and total intake, without classifying this as a deficiency trial.", "basis": "C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check baseline nutritional testing, dietary records and intake by condition to distinguish deficiency status from the contribution of the added dose.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Baseline vitamin C status, habitual diet and total vitamin C intake are recorded as not reported in the stored summary. The current trial is not classified as a trial of vitamin C deficiency correction.", "condition_status": "Unverified", "status_reason": "The current input has no actual baseline test/intake values, so deficiency status and total exposure cannot be established. This does not constitute new verification that reporting is absent from the entire external full text.", "missingness": "Baseline vitamin C test values, dietary assessment and total intake", "uncertainty": "Baseline vitamin C test values, dietary assessment and total intake. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion" }, { "item_id": "N07", "question_type": "Baseline risk screening", "question": "Have selection boundaries relating to iron, renal status and G6PD been verified?", "needed": "Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records", "role": "Required", "role_reason": "Needed to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases.", "application_exception": "The safety context of G6PD and high-dose intravenous administration is not transferred to the 80 mg oral exposure as an equivalent risk estimate.", "criterion": "Retain unverified information for each entry/screening record and identify boundaries for safety interpretation appropriate to the route and dose.", "basis": "C04: M03 §3.2.1; detailed population criteria are internally designed / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check entry-test tables and exclusion/safety-screening records to examine the actual eligible population and separate vulnerable groups.", "current_reports": [ "S01", "S14", "S15" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Entry criteria for TSAT and renal function, and screening for iron overload and G6PD, remain in unresolved_facets. This unverified information does not justify directly applying risks from high-dose intravenous vitamin C materials to the current oral condition.", "condition_status": "Unverified", "status_reason": "Specific screening criteria/results cannot be verified from the current input. No conclusion that the individuals are safe candidates is drawn.", "missingness": "TSAT/renal entry criteria and iron-overload/G6PD screening records", "uncertainty": "TSAT/renal entry criteria and iron-overload/G6PD screening records. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records" }, { "item_id": "N08", "question_type": "Active ingredient identity", "question": "What are the identities of the trial's vitamin C ingredient and product?", "needed": "Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations", "role": "Required", "role_reason": "Needed to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C.", "application_exception": "Do not fill unverified manufacturing origin, lot or purity with estimates, or infer product supply/funding from a brand name.", "criterion": "Distinguish food-grade L-ascorbic acid as a single ingredient from verified/unverified product attributes.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check product specifications, trial batches and ingredient records to verify a reproducible identity for the active ingredient and formulation.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The added ingredient is food-grade, single-ingredient L-ascorbic acid from Sigma Aldrich. Manufacturing origin, lot and exact purity are recorded as not reported in the stored summary. It is distinguished from sodium/calcium salts, juice and multinutrient products.", "condition_status": "Partly verified", "status_reason": "The active ingredient and product designation are verified, but manufacturing/batch/purity information remains outstanding. Equivalence to other formulations has not been verified.", "missingness": "Manufacturing origin, lot, exact purity and actual batch specifications", "uncertainty": "Manufacturing origin, lot, exact purity and actual batch specifications. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations" }, { "item_id": "N09", "question_type": "Route of administration", "question": "By what route and in what prepared form were they administered together?", "needed": "Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions", "role": "Required", "role_reason": "Needed to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route.", "application_exception": "An intravenous-administration trial is not required as direct evidence for this narrow oral condition.", "criterion": "Identify the addition of a single-ingredient oral aqueous solution together with exposure to the same iron capsule, excluding other routes/formulations.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check preparation/administration procedures, and design separate questions and direct comparisons when examining other routes/media.", "current_reports": [ "S01", "S15" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Single-ingredient L-ascorbic acid dissolved in water was administered orally together with iron in the fasted state. The effect size is not transferred to intravenous administration, juice, foods, salts, combination products or other iron formulations.", "condition_status": "Met", "status_reason": "The criteria for documenting the actual route and excluded formulations are met. This does not verify efficacy of other formulations or safety by route.", "missingness": "Equivalence of other routes/formulations and actual preparation details require separate examination.", "uncertainty": "Equivalence of other routes/formulations and actual preparation details require separate examination. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions" }, { "item_id": "N10", "question_type": "Iron exposure amount", "question": "How are the 100 mg capsule and the amount of isotope label distinguished?", "needed": "The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron", "role": "Required", "role_reason": "Needed to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption.", "application_exception": "Do not add the reported label amount to create a new total or recalculate the authors' molar ratio.", "criterion": "Preserve separately the nominal capsule amount, label amount, unverified total and author-reported molar ratio.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check preparation/label masses and the actual total-dose table to distinguish the different estimands for fractional and absolute amounts.", "current_reports": [ "S01", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The same Ferrum Hausmann 100 mg Kaps is reported to contain 100 mg of elemental iron, with an isotope label of 3 mg also reported. The authors' molar ratio of 0.24:1 is preserved. Because the record states that total elemental iron including the label was not presented in a separate table, absolute absorbed iron in mg is not calculated.", "condition_status": "Partly verified", "status_reason": "The capsule amount, label amount and reported molar ratio have been linked, but the actual total elemental iron amount is unverified. No new addition or calculation of absolute absorption was performed.", "missingness": "Actual total elemental iron including the label and the preparation mass table", "uncertainty": "Actual total elemental iron including the label and the preparation mass table. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron" }, { "item_id": "N11", "question_type": "Actual comparator", "question": "Apart from the added 80 mg, are the iron and water exposures identical in the main comparison?", "needed": "The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments", "role": "Required", "role_reason": "Needed to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments.", "application_exception": "Compare only the two selected conditions, without forcing all elements of the 6 different conditions into a common control.", "criterion": "Link the selected main comparison to whether it adds only 80 mg of ascorbic acid under the same fasted iron-and-water conditions.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the composition/common-treatment table for each dosing condition to audit the actual comparison of interest and differences in concomitant treatments/media.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The comparison concerns conditions in which the same participant takes a labeled ferrous fumarate capsule with 200 mL of water. In the main comparison, the difference is whether 80 mg of food-grade L-ascorbic acid is added. Other comparisons among the 6 conditions are not merged with these two conditions.", "condition_status": "Partly verified", "status_reason": "The retained manuscript explicitly specifies the same iron-and-water comparator. A current cross-check of the original composition table and condition-specific concomitant-treatment/adherence records remains outstanding.", "missingness": "Condition-specific composition, concomitant treatments/adherence and verification of actual administration", "uncertainty": "Condition-specific composition, concomitant treatments/adherence and verification of actual administration. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments" }, { "item_id": "N12", "question_type": "Fasting and timing", "question": "What were the meal and morning dosing conditions for the absorption comparison?", "needed": "Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition", "role": "Required", "role_reason": "Needed to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals.", "application_exception": "Do not arbitrarily attribute the 1 withdrawal due to difficulty adhering to fasting to a safety event or failure of a particular condition.", "criterion": "Identify fasting, administration time, simultaneous administration and unverified adherence separately.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check meal/administration diaries and observation records, and examine questions about dosing after meals or at different times through separate comparisons.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The main comparison concerns simultaneous administration of the same iron and water with vitamin C at 07:00–09:00 in the morning after an overnight fast. An identical effect size with meals has not been verified.", "condition_status": "Partly verified", "status_reason": "The nominal fasting and timing conditions are preserved. Individual adherence and corresponding effect data for other times/meals have not been cross-checked in the current work.", "missingness": "Fasting/timing adherence and separate comparative data for dosing after meals or at other times", "uncertainty": "Fasting/timing adherence and separate comparative data for dosing after meals or at other times. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition" }, { "item_id": "N13", "question_type": "Exposure and blood-sampling schedule", "question": "Have single-exposure absorption measurements been distinguished from the duration of long-term use?", "needed": "Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information", "role": "Required", "role_reason": "Needed to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects.", "application_exception": "Preserve the Methods schedule with its source attribution, without treating it as a definitive resolution of the conflicting final blood-sampling dates.", "criterion": "Separate exposure 1 time per condition from the incorporation-measurement window, linking both the Methods schedule and the unresolved schedule conflict.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check dosing/blood-sampling schedules, figures and registration history by date to verify the exposure window and label-specific observation windows.", "current_reports": [ "S01", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Each condition involves exposure 1 time, with crossover dosing on days 1·3·5·22·24·26. According to the Methods section, blood sampling occurs on days 22/43, with label-specific incorporation measured 17–21 days after each dose. The recorded conflict over the final blood-sampling day remains unresolved, and this is not interpreted as an effect of long-term use.", "condition_status": "Partly verified", "status_reason": "The Methods schedule and single exposure are preserved. The conflict with other records over the final blood-sampling day remains, so the schedule is not promoted to a definitive final schedule.", "missingness": "Cross-check of the conflicting final blood-sampling day across the original schedule/figures/registration history", "uncertainty": "Cross-check of the conflicting final blood-sampling day across the original schedule/figures/registration history. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information" }, { "item_id": "N14", "question_type": "Allocation and blinding", "question": "What was the actual extent of crossover allocation and blinding?", "needed": "Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data", "role": "Required", "role_reason": "Needed to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized.", "application_exception": "An open-label design or unreported blinding does not automatically render the measurement invalid.", "criterion": "Distinguish the actual open-label randomized crossover design and reported/unreported procedures in relation to the endpoint.", "basis": "E01: M08 §8.1–8.2.3; internal application / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / C04: M03 §3.2.1; detailed population criteria are internally designed. The rationale for application to this case is to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check random-sequence generation, allocation/testing procedures and baseline data by sequence to examine allocation limitations for the selected result.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The study is recorded as a randomized, open-label crossover trial with a computer-generated sequence. Allocation concealment and laboratory blinding remain not reported in the retained assessment. The objectivity of the isotope method is not used as evidence that blinding was completed.", "condition_status": "Partly verified", "status_reason": "The design and sequence generation were reported, but actual information on concealment/laboratory-blinding procedures remains outstanding.", "missingness": "Allocation concealment, laboratory blinding and baseline/allocation records by sequence", "uncertainty": "Allocation concealment, laboratory blinding and baseline/allocation records by sequence. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data" }, { "item_id": "N15", "question_type": "Participant and observation denominators", "question": "Can 35 participants, 34 participants and 204 observations be distinguished?", "needed": "35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions", "role": "Required", "role_reason": "Needed to avoid counting repeated observations as people or combining the same 34 participants as two independent groups.", "application_exception": "Do not turn 204 observations into 204 participants or calculate a new total participant count.", "criterion": "Link the original enrollment/completion/analysis/observation counts unchanged, identifying the comparison as paired within the same 34 participants.", "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid counting repeated observations as people or combining the same 34 participants as two independent groups. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check participant flow and condition-specific analysis tables to distinguish denominators for people, repeated observations and pairs.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Of 35 enrolled participants, 34 completed all 6 conditions and were analyzed. The 204 observations are repeated observations, not 204 people. The main comparison uses the same 34 participants, whose counts are not combined as sample sizes for two independent groups.", "condition_status": "Partly verified", "status_reason": "The retained enrollment, analysis and observation denominators have been distinguished. A current cross-check of the original condition-specific missing-data/analysis flowchart remains outstanding.", "missingness": "Original tables of condition-specific analysis/missing measurements and participant linkage", "uncertainty": "Original tables of condition-specific analysis/missing measurements and participant linkage. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions" }, { "item_id": "N16", "question_type": "Analysis and attrition", "question": "Have the completer analysis, withdrawal and imputation records been distinguished?", "needed": "Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data", "role": "Required", "role_reason": "Needed to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation.", "application_exception": "Do not attribute the withdrawal to an adverse effect of iron or vitamin C while its condition remains unverified.", "criterion": "Preserve separately the distinction between the analysis of 34 completers and enrollment of 35 participants, the imputed variable and the unverified condition of withdrawal.", "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the flow diagram, missing-data/imputation rules and analysis code to examine the distinction between effects of assignment and adherence, and the possible influence of attrition.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "This is a per-protocol completer analysis; 1 of the 35 participants withdrew after the first visit because of difficulty maintaining the fast. The condition involved is unverified. CRP imputation in the retained assessment is a separate record from imputation of fractional iron absorption.", "condition_status": "Partly verified", "status_reason": "The reason for attrition and the analysis/imputation boundaries are preserved. The condition of withdrawal, original details of missing-data handling and analysis of all randomized participants are unverified.", "missingness": "Condition of withdrawal, handling of missing FIA data and definitions of assignment/adherence analyses", "uncertainty": "Condition of withdrawal, handling of missing FIA data and definitions of assignment/adherence analyses. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data" }, { "item_id": "N17", "question_type": "Handling of the crossover design", "question": "How were adherence and period, sequence and carryover effects handled?", "needed": "Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast", "role": "Required", "role_reason": "Needed to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals.", "application_exception": "Unverified interactions are not treated as established carryover bias or a null effect.", "criterion": "Separate the reporting level for supervised administration from unverified crossover handling, and link the scope of verification for paired/adjusted effects.", "basis": "E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check administration logs, the repeated-measures model, period/sequence terms and prespecified contrasts to examine the adequacy of the crossover handling.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Supervised administration is recorded, but interactions involving period, sequence and carryover effects remain in unresolved_facets. A comparison within the same participants is distinguished from estimation of an adjusted crossover effect.", "condition_status": "Unverified", "status_reason": "Supervised administration alone cannot establish the actual model contrasts or handling of sequence/carryover.", "missingness": "Adherence records, crossover-model contrasts and period/sequence/carryover interactions", "uncertainty": "Adherence records, crossover-model contrasts and period/sequence/carryover interactions. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast" }, { "item_id": "N18", "question_type": "Isotope measurement", "question": "Which test and unit define the fractional iron absorption result?", "needed": "Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality", "role": "Required", "role_reason": "Needed to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements.", "application_exception": "An objective test is not converted into direct proof of clinical events/patient-centered benefit.", "criterion": "Link the selected endpoint to stable-isotope-derived FIA (%) and distinguish it from other iron/hemoglobin outcomes.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check isotope assays, label-specific incorporation/dilution procedures and outcome units to examine measurement limitations of the selected endpoint.", "current_reports": [ "S01", "S16" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The endpoint is FIA (%) obtained from erythrocyte incorporation of 54Fe·57Fe·58Fe and isotope dilution. The incorporation model uses measurements 17–21 days after administration of each label; blood iron concentration or an increase in Hb is not substituted for absorption.", "condition_status": "Partly verified", "status_reason": "The assay type, unit and measurement window have been linked. A current cross-check of original assay quality and actual label-specific measurements remains outstanding.", "missingness": "Label-specific assays/quality control and original isotope-dilution measurement data", "uncertainty": "Label-specific assays/quality control and original isotope-dilution measurement data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality" }, { "item_id": "N19", "question_type": "Incorporation model", "question": "What does the assumption of 80% erythrocyte incorporation mean?", "needed": "The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method", "role": "Required", "role_reason": "Needed to avoid turning a model assumption into an identical incorporation rate actually measured in every participant.", "application_exception": "The IAEA methods explanation is neither an individual measurement in participants in 3115 nor a new replication trial.", "criterion": "Identify the 80% assumption and the unverified individual fractions, distinguishing methodological explanation from clinical outcome data.", "basis": "E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid turning a model assumption into an identical incorporation rate actually measured in every participant. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the absorption model/assumptions against individual incorporation data, and examine interpretation of changes to assumptions through an appropriate prespecified analysis.", "current_reports": [ "S01", "S16" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Fractional iron absorption is modeled assuming 80% erythrocyte incorporation. Actual individual incorporation fractions are unverified. The IAEA methods section in S16 is historical background for the calculation principles; it neither verifies incorporation rates in these participants nor provides independent effect data.", "condition_status": "Partly verified", "status_reason": "The assumption and methodological source are preserved. Individual incorporation fractions and actual model-sensitivity data have not been verified.", "missingness": "Individual incorporation fractions and data for checking the applied model/assumptions", "uncertainty": "Individual incorporation fractions and data for checking the applied model/assumptions. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method" }, { "item_id": "N20", "question_type": "Prespecified endpoints and multiple comparisons", "question": "Have the prespecified hierarchy and analysis plan for the selected absorption comparison been verified?", "needed": "Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes", "role": "Required", "role_reason": "Needed to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting.", "application_exception": "Failure to acquire a plan is not converted into proof of nonregistration or outcome switching.", "criterion": "Separate the current page's comparison from the unverified prospective trial hierarchy, and retain the record of no adjustment for multiple comparisons.", "basis": "E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check initial/revised registrations, the protocol, SAP and actual results for the 6 conditions to verify the endpoint/contrast hierarchy and reasons for changes.", "current_reports": [ "S01", "S04", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The original evidence concerns 1 main comparison selected for the page from the 6 conditions in the same participants. The official prospective endpoint hierarchy is unverified, and the retained assessment records no adjustment for multiple comparisons. This limitation alone does not establish selective reporting.", "condition_status": "Unverified", "status_reason": "The current input lacks an official prior plan/history, so prespecification of the page's comparison and the multiple-comparison plan cannot be cross-checked.", "missingness": "Official prospective endpoint hierarchy, protocol/SAP and multiple-comparison plan", "uncertainty": "Official prospective endpoint hierarchy, protocol/SAP and multiple-comparison plan. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes" }, { "item_id": "N21", "question_type": "Main absorption observation", "question": "What are the actual medians, IQRs and P for the two conditions?", "needed": "FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast", "role": "Required", "role_reason": "Needed to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct.", "application_exception": "An IQR is not a confidence interval, and a significant P is not sufficient evidence of clinical importance or precision.", "criterion": "Attribute the added condition's 26.7% (IQR 19.1–32.6%) and the no-addition condition's 20.6% (IQR 12.3–25.5%), the same 34 participants and P<0.001 to their original location.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the original table/figure and test contrast to verify agreement of the reported medians, distributions, P and analysis denominator.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "With the added 80 mg, median FIA is 26.7% and the IQR is 19.1–32.6%. Without the addition, it is 20.6%, with an IQR of 12.3–25.5%; P<0.001 for the comparison in the same 34 participants is preserved. The IQR is not a CI.", "condition_status": "Partly verified", "status_reason": "The stored summary's numbers, direction and denominator have been linked. The original test contrast, paired interval and a current full-text check of the original table/figure remain outstanding.", "missingness": "Original table/figure, exact test contrast and paired-effect interval", "uncertainty": "Original table/figure, exact test contrast and paired-effect interval. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast" }, { "item_id": "N22", "question_type": "Historical descriptive arithmetic", "question": "As which estimand are 6.1%p, 1.296 and 29.6% preserved?", "needed": "Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects", "role": "Required", "role_reason": "Needed to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate.", "application_exception": "Do not perform new arithmetic or reconstruct paired/standardized effects from IQR/P.", "criterion": "Preserve the historical 6.1%p, 1.296 and approximately 29.6% only as descriptive comparisons of marginal medians.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check inputs, units and estimands in the retained calculation record against the original results to distinguish descriptive arithmetic from inferential estimation.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The historical calculation record's median difference of 6.1%p, median ratio of 1.296 and approximately 29.6% higher value are descriptive comparisons of marginal medians. They are not the mean/median of individual changes or an adjusted crossover effect. No calculation was performed this time.", "condition_status": "Met", "status_reason": "The historical arithmetic's units, estimand and limits of application have been kept distinct and unchanged. No new effect size or paired confidence interval was created.", "missingness": "Individual paired or model-adjusted contrasts remain unverified and require separate data.", "uncertainty": "Individual paired or model-adjusted contrasts remain unverified and require separate data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects" }, { "item_id": "N23", "question_type": "Variance and intervals", "question": "Can the CI, SD and SE for the exact paired effect be verified?", "needed": "The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast", "role": "Required", "role_reason": "Needed to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study.", "application_exception": "Absent or unverified variances/intervals are not calculated and inserted, nor interpreted as absence of an absorption direction.", "criterion": "Retain the empty interval/variance values and reasons for nonverification for the current contrast, without substituting variance from another study.", "basis": "E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed. The rationale for application to this case is to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Acquire the analysis output, paired data and model SE/CI for the selected contrast, and cross-check them against the original estimand/denominator.", "current_reports": [ "S01", "S03" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The paired or model-adjusted contrast, CI, SD, SE and exact test statistic are unverified. Fields such as mean_changes, sd_changes, standard_error and interval in the original calculation structure are empty. They are not reconstructed from the IQR and P<0.001, and a planning SD from another study is not used.", "condition_status": "Unverified", "status_reason": "The current input lacks the actual variance/interval for this contrast. A significant P alone cannot establish precision or a standardized effect.", "missingness": "Paired/adjusted effect, variance, confidence interval and test output for the selected contrast", "uncertainty": "Paired/adjusted effect, variance, confidence interval and test output for the selected contrast. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast" }, { "item_id": "N24", "question_type": "Importance and clinical benefit", "question": "Has the clinical meaning of the FIA difference been verified?", "needed": "A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data", "role": "Supplementary; required for extension to clinical benefit", "role_reason": "Needed to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health.", "application_exception": "Do not require an anemia-event trial for the narrow absorption question or invent a common numerical MCID.", "criterion": "Distinguish the absorption observation from unverified clinical importance, and retain Hb/health questions as separate endpoints.", "basis": "E05: M15 §15.3.1–15.3.3; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Examine the basis for absorption's importance and direct clinical outcomes by endpoint, designing a separate long-term clinical comparison if needed.", "current_reports": [ "S01", "P907" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The retained manuscript describes the direction of absorption positively, but states that clinical meaning and the exact paired magnitude are unverified. FIA is a physiological surrogate; this result does not establish anemia treatment, Hb recovery or improvement in fatigue or health.", "condition_status": "Unverified", "status_reason": "A validated threshold for clinical importance and direct clinical-benefit data for the condition have not been verified. This does not erase the FIA observation or turn it into an effect of 0.", "missingness": "An importance threshold for absorption and direct clinical outcome/long-term follow-up data", "uncertainty": "An importance threshold for absorption and direct clinical outcome/long-term follow-up data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data" }, { "item_id": "N25", "question_type": "Registration identity", "question": "How have the article's registration number and the probably matching mirror been distinguished?", "needed": "The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history", "role": "Required", "role_reason": "Needed to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration.", "application_exception": "Do not label failure to acquire the official history as absence of registration, or invent a link when the mirror's actual URL is unavailable.", "criterion": "Identify the mismatch in the printed number and the provisional link to NCT05414474 separately, retaining the official history as unverified.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the official initial/revised registration history against the population, 6 conditions, investigators and enrollment in the article/mirror to verify the actual link.", "current_reports": [ "S01", "S04", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The record states that the printed NCT04074707 appears to concern a pregnancy study and does not match this population. NCT05414474 was provisionally linked by inference from a mirror as a probable registration with the same 6 conditions, investigators and enrollment. The historical record of inability to access the official history is preserved, without treating it as absence of registration or a confirmed link.", "condition_status": "Conflicting information", "status_reason": "The current input records a population mismatch for the printed registration number and a provisional alternative link. Without a cross-check of the official history, registration identity cannot be marked as resolved.", "missingness": "Official registration version history, correction of the article's registration and the actual mirror URL", "uncertainty": "Official registration version history, correction of the article's registration and the actual mirror URL. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history" }, { "item_id": "N26", "question_type": "Preservation of discrepancies", "question": "Have conflicts involving recruitment, blood sampling, registration criteria and secondary results been preserved?", "needed": "Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution", "role": "Required", "role_reason": "Needed to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value.", "application_exception": "Do not treat every difference in values across conditions as a conflict. Do not add counterpart values for conflicts when they are absent from the current original stored summary.", "criterion": "Identify the retained types of conflict and their scope, leaving unverified any parts lacking both original values/locations.", "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the article's Methods, figures/results, original registration versions and correction records fact by fact, preserving incompatible pairs and the evidence for resolution.", "current_reports": [ "S01", "S17" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "QA04 records preservation of conflicts involving recruitment year, blood-sampling day, registration criteria, coffee P values and the reference median. Because the current stored summary does not contain all original values from both sides, no counterpart year, blood-sampling day, coffee P or median is newly supplied. Blood sampling on days 22/43 in the Methods section is also retained only as that section's record.", "condition_status": "Conflicting information", "status_reason": "The historical conflict records are explicit and unresolved. The counterpart original values have not been reread in the current work, so no new confirmation or resolution of conflicts is claimed.", "missingness": "Original values/locations on both sides of each conflict, correction history and actual evidence of resolution", "uncertainty": "Original values/locations on both sides of each conflict, correction history and actual evidence of resolution. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution" }, { "item_id": "N27", "question_type": "Supplementary material", "question": "What is the actual acquisition scope for S1, S2 and the supplementary material?", "needed": "Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records", "role": "Required", "role_reason": "Needed to avoid treating appendix references and link correction as verification of appendix content.", "application_exception": "The 403 on 2026-09-16 is a historical failure. External access not attempted this time is not marked as current inaccessibility.", "criterion": "Preserve the actual download URL, past failure and unverified S1/S2, keeping the current material type marked as not read.", "basis": "C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating appendix references and link correction as verification of appendix content. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Upon an authorized actual acquisition event, cross-check the DOCX version/original bytes and S1/S2 against the main-text contrasts, denominators and variances.", "current_reports": [ "S01", "S03" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "S03 refers to S01's approximately 22.1 KB supplementary DOCX and S1/S2. QA06 corrected the link to the actual download URL and recorded the 403 failure at that time. External access has not been attempted in the current work; the content of S1/S2 and condition-specific analyses remain unverified.", "condition_status": "Unverified", "status_reason": "Supplementary-material content is absent from the current input, and a past acquisition failure is recorded. The existence of a link alone does not support a claim that the full text was read or the analysis verified.", "missingness": "Original S1/S2 tables, appendix version/bytes and actual acquisition records", "uncertainty": "Original S1/S2 tables, appendix version/bytes and actual acquisition records. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records" }, { "item_id": "N28", "question_type": "Additional dose and juice", "question": "Can the findings be extended to the 500 mg comparison or juice alone?", "needed": "Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately", "role": "Supplementary; required for extension to dose/juice claims", "role_reason": "Needed to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect.", "application_exception": "Do not require trials of every dose for the narrow 80 mg main comparison.", "criterion": "Attribute P=0.226 for 500 mg to its corresponding contrast, without interpreting it as equivalence, an optimal dose or an effect of juice alone.", "basis": "E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Examine prespecified dose contrasts/intervals, and address equivalence, optimal-dose or juice-alone questions through appropriate separate direct comparisons.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The record reports P=0.226 for no verified additional increase with 500 mg over 80 mg, although absorption with the former condition was higher than with water. This does not prove equivalence or an optimal dose. The record that orange juice alone was not measured is retained.", "condition_status": "Partly verified", "status_reason": "The reported direction for the secondary dose and the limits on extrapolation are preserved. Paired intervals, an equivalence plan and a direct juice-alone comparison have not been verified.", "missingness": "Dose contrasts/intervals, a prespecified equivalence plan and a separate juice-alone comparison", "uncertainty": "Dose contrasts/intervals, a prespecified equivalence plan and a separate juice-alone comparison. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately" }, { "item_id": "N29", "question_type": "Other comparisons among the 6 conditions", "question": "Have secondary comparisons involving meals, coffee, timing and similar factors been kept separate from the main comparison?", "needed": "Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians", "role": "Required", "role_reason": "Needed to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state.", "application_exception": "The current input only references other_conditions.json; it was not opened. No secondary-condition numbers or counterpart values for conflicts are filled in.", "criterion": "Separate the two selected conditions from other contrasts, leaving unavailable secondary results within the bibliographic/reference scope.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Check the table of 6 conditions, prespecified contrasts and original other_conditions records to attribute each result individually to the corresponding composition/time.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The current evidence describes a crossover trial with 6 conditions and references secondary material in other_conditions.json. That separate file was not read this time. Conflicts in coffee P and the reference median are retained as QA04 records; those values are neither newly extracted nor merged into the main comparison.", "condition_status": "Unverified", "status_reason": "Detailed contrasts/numbers for secondary conditions are absent from the current stored summary, so their actual direction and counterpart values for conflicts cannot be established.", "missingness": "Composition/contrasts for the 6 conditions, original tables of secondary results and locations of conflicts", "uncertainty": "Composition/contrasts for the 6 conditions, original tables of secondary results and locations of conflicts. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians" }, { "item_id": "N30", "question_type": "Related dietary studies", "question": "What roles do the long-term balance, dietary and nonsimultaneous-administration studies in S05–S08 play?", "needed": "Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators", "role": "Required", "role_reason": "Needed to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone.", "application_exception": "Do not reconstruct unprovided numbers, effects or durations from bibliographic entries that only reference sources.json.", "criterion": "Retain S05–S08 as related material, while explaining how their conditions/measures differ from the same fasted-capsule comparison with simultaneous 80 mg administration.", "basis": "E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check each article's methods/original results separately to verify differences in simultaneous exposure, dietary changes, balance and isotope endpoints.", "current_reports": [ "S05", "S06", "S07", "S08" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "S05–S08 concern apparent absorption with low iron stores, ongoing absorption/status, total-diet nonheme iron, and iron status/tea/AA in young Indian women. The original counterview records that null long-term balance findings, nonsimultaneous administration and whole-diet changes differ from this main comparison. The current bibliographic entries do not contain actual numerical results for each study.", "condition_status": "Partly verified", "status_reason": "The related questions and the historical boundaries on treating them as refutation have been read. Detailed exposure, denominators and results for each trial cannot be directly cross-checked from the current input alone.", "missingness": "Individual methods, diet/exposure, endpoints, denominators and original results for S05–S08", "uncertainty": "Individual methods, diet/exposure, endpoints, denominators and original results for S05–S08. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators" }, { "item_id": "N31", "question_type": "Other populations and iron formulations", "question": "Can S09–S12 and S21 be combined as effects for the same main comparison?", "needed": "Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules", "role": "Required", "role_reason": "Needed to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition.", "application_exception": "Do not claim verification of a full text or direct result solely from S11's title and methods citation or S12's publication timing.", "criterion": "Identify each bibliographic entry's different population/intervention/endpoint, without automatically adding it to the count of directly eligible families.", "basis": "C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Verify the actual populations, exposure/concomitant treatments, endpoints and study families of related studies individually to assess their directness for this question.", "current_reports": [ "S09", "S10", "S11", "S12", "S21" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "S09 concerns overweight/obese women; S10 concerns ferrous fumarate, AA and Na2EDTA; S11's title concerns fortified foods, millet porridge and phytase/AA. S12 is a hematological comparison of daily/alternate-day iron, not single-ingredient AA addition. S21 provides a lead concerning inflammation, hepcidin and absorption in overweight women. No numerical results beyond the bibliographic verification level are added.", "condition_status": "Partly verified", "status_reason": "The roles of different questions in the titles and retained locations have been distinguished. Detailed original results/denominators and actual family identities are not provided in the current summary.", "missingness": "Populations/compositions, measures, denominators/results and unique families for S09–S12 and S21", "uncertainty": "Populations/compositions, measures, denominators/results and unique families for S09–S12 and S21. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules" }, { "item_id": "N32", "question_type": "Registration and review leads", "question": "Has discovery of registrations/reviews in S18–S20 been treated as verification of results?", "needed": "Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results", "role": "Required", "role_reason": "Needed to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials.", "application_exception": "When an exact URL is unverified, do not attach a portal homepage as though it were the link to the specific original record.", "criterion": "Retain the level of plan/index/review discovery, distinguishing the absence of results, included-trial information or a confirmed URL.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check posted registration results, review tables of included trials and exact records to distinguish unique trials/reports from information that remains a plan.", "current_reports": [ "S18", "S19", "S20" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "S18 is the indexed Study Plan for a registration concerning insect-derived dietary iron and chitin/AA. S19 is an indexed title of a fruit/juice review, with its full text recorded as not acquired. S20 is a title lead for FeHydroA; its exact registration URL remains unresolved. These are not counted as independent results for the current main comparison.", "condition_status": "Unverified", "status_reason": "Plan/discovery identities are present, but no material is available to verify direct results, the review's included trials or the exact original S20 record.", "missingness": "Actual S18 results, S19's included-trial table, and the exact S20 registration and results", "uncertainty": "Actual S18 results, S19's included-trial table, and the exact S20 registration and results. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results" }, { "item_id": "N33", "question_type": "Funding and product supply", "question": "What is the verification scope for ETH funding, product supply and conflicts of interest?", "needed": "Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships", "role": "Required", "role_reason": "Needed to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name.", "application_exception": "The existing I2 axis is preserved as a historical value, without being used as a new independence grade or certification of replication across families.", "criterion": "Distinguish reported funding/declarations from unreported product supply, retaining relationships that remain unverified.", "basis": "C10: Chamgap's own independence/attribution criteria. The formal methods sections used in this pilot do not endorse every detail of this item / C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application. The rationale for application to this case is to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check funding/acknowledgments/COI and product-supply records to examine the level of disclosure and scope of funding/institutional independence.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The retained record describes funding from the ETH Zurich Laboratory of Human Nutrition and a declaration of no competing financial interests. The Ferrum Hausmann/Vifor and Sigma Aldrich product names are not evidence of donated products or manufacturer funding. Product supply remains not reported.", "condition_status": "Partly verified", "status_reason": "The funding and declaration level are documented, but product supply and the full set of relationships cannot be established. The existing I2 is not reused as a new criterion assessment.", "missingness": "Detailed records of product supply/support and institutional/author relationships", "uncertainty": "Detailed records of product supply/support and institutional/author relationships. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships" }, { "item_id": "N34", "question_type": "Collection of trial harms data", "question": "Can adverse reactions and withdrawal frequencies under the same conditions be verified?", "needed": "Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal", "role": "Supplementary; required for extension to comparative harms/safety", "role_reason": "Needed to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety.", "application_exception": "Do not arbitrarily classify the 1 withdrawal due to difficulty maintaining the fast as vitamin C harm or as 0 events.", "criterion": "Separate the record of AEs not reported from the withdrawal reason/unverified condition, without newly calculating incidence or establishing causality.", "basis": "E10: M19 §19.1.2–19.2.4; internal application / H01: M19 §19.1.2–19.2.4; detailed distinctions are internally designed / H02: Design-specific harms questions in M19 §19.2; temporal-relationship details are internally designed / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application / H04: M19 §19.1.2–19.2.4; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check the AE collection plan, condition-specific event/exposure/withdrawal tables and follow-up records to verify event frequency and the scope of signal interpretation.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Condition-specific adverse-reaction counts are recorded as not reported in the stored summary. Of 35 participants, 1 withdrew after the first visit because of difficulty maintaining the fast, but the condition is unverified. This is not recast as 0 AEs or an AA-related withdrawal.", "condition_status": "Unverified", "status_reason": "Without condition-specific events, exposure denominators/periods and collection definitions, comparative harms, incidence and causality cannot be established.", "missingness": "Condition-specific AE collection/events, exposure/periods and the condition of withdrawal", "uncertainty": "Condition-specific AE collection/events, exposure/periods and the condition of withdrawal. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal" }, { "item_id": "N35", "question_type": "Official safety background", "question": "Which safety questions do the NIH, NIDDK and NCI materials address?", "needed": "Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose", "role": "Supplementary; required for extension to individual/vulnerable-group safety", "role_reason": "Needed to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial.", "application_exception": "The UL is neither an individual's recommended intake nor a guarantee of unrestricted safety, and the same adult threshold is not extended to age 18.", "criterion": "Separate the actual population, route/dose and general background role of each official source.", "basis": "E10: M19 §19.1.2–19.2.4; internal application / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed. The rationale for application to this case is to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the populations/routes/doses in official safety materials with the trial, examining direct harms comparisons separately from general cautions.", "current_reports": [ "S13", "S14", "S15" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The retained general safety background includes a total-intake upper limit of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload and G6PD in the high-dose intravenous context. S13–S15 are official explanatory sources; they are not condition-specific event counts for oral 80 mg or individual intake recommendations.", "condition_status": "Met", "status_reason": "The interpretive routes and age/exposure boundaries for each background source have been distinguished. This does not mean that external original texts or individual safety have been verified in the current work.", "missingness": "Direct harms data for this oral condition and evidence for vulnerable groups/long-term exposure are unverified.", "uncertainty": "Direct harms data for this oral condition and evidence for vulnerable groups/long-term exposure are unverified. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose" }, { "item_id": "N36", "question_type": "Extension of applicability", "question": "Can the same effect be applied to other populations, durations and health endpoints?", "needed": "Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints", "role": "Supplementary; required for extended claims", "role_reason": "Needed to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone.", "application_exception": "Trials for each extension question are not required to complete the narrow main comparison, and these questions are not converted into a general absence of evidence or an effect of 0.", "criterion": "Distinguish the original population/single-exposure FIA from unverified direct evidence for excluded populations and long-term/clinical endpoints.", "basis": "C04: M03 §3.2.1; detailed population criteria are internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Examine direct comparisons and prespecified subgroups/interactions separately by population, exposure, duration and endpoint, designing necessary extension questions separately.", "current_reports": [ "S01", "P907" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Do not generalize directly to men, older people, people with normal iron stores, anemia, pregnancy/lactation, children, renal disease, iron overload or inflammatory disease. The direction of acute FIA is not a result for long-term maintenance, anemia treatment, fatigue/vitality or overall safety.", "condition_status": "Not applicable", "status_reason": "Confirmation of extended effects does not apply to this table's narrow question. No judgment has been made that evidence for each extension is absent or that the effect is null.", "missingness": "Direct verification in other populations, of long-term maintenance or of clinical health outcomes is a separate question.", "uncertainty": "Direct verification in other populations, of long-term maintenance or of clinical health outcomes is a separate question. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints" }, { "item_id": "N37", "question_type": "Preservation of the existing assessment", "question": "Have the original C/50, Caution and axes been kept from being reused as new criterion statuses?", "needed": "Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses", "role": "Required", "role_reason": "Needed to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification.", "application_exception": "The original grade and numbers are neither deleted nor regraded. document_quality A and efficacy C are different original fields.", "criterion": "Preserve the original assessment, axes and historical calculations unchanged, and let new criterion statuses represent only individual record/gap review.", "basis": "C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E05: M15 §15.3.1–15.3.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare hashes/values between the original input and the produced version to check preservation of the assessment, axes and calculations, and audit the meaning of criterion statuses separately.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "Preserve the original C/50, Caution, the B·S·R1·I2·EX·CX·B2 axes and document quality as historical values. The existing scoring explanation involving n<200/completer analysis is not a minimum-participant criterion for the new table. No new calculation, grade or fulfillment rate was created.", "condition_status": "Met", "status_reason": "The roles of existing values and new record statuses have been separated. Met in the table does not signify the original efficacy grade, confirmation of safety or a probability.", "missingness": "Reassessment of the existing judgment and new scoring are outside the work performed in this scope.", "uncertainty": "Reassessment of the existing judgment and new scoring are outside the work performed in this scope. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses" }, { "item_id": "N38", "question_type": "Reference dates and version records", "question": "Have this table's input, criterion freeze, application and verification scope been recorded?", "needed": "The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application", "role": "Required", "role_reason": "Needed to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment.", "application_exception": "These are internally developed criteria for a development case already read. The 59 searches and 1 failure are historical records, not new searches in this work.", "criterion": "Link criterion versions/hashes with actual freeze→record→application→writing times, explicitly stating the scope and absence of new work.", "basis": "C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.", "condition_origin": "Internally developed criteria written individually after reading the current retained manuscript/evidence and bibliography for 3115 and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Audit original bytes, pointers, versions/event times and row-level model records, updating new-material/criterion-revision events separately.", "current_reports": [ "S01" ], "existence": "Limited to the current retained manuscript/structure and bibliography, the explicitly unverified information and the scope of verification at that time.", "acquired_read": "Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.", "observation": "The evidence cutoff is 2026-09-16; records of 59 general web searches and 1 failed PubMed-specific search at that time are preserved. The 2026-10-05 review described here read the designated stored summary and family definitions, recording actual copies/hashes and individual criterion freezes/applications. External searches, full-text reading, API access, clinical calculations/reassessment and deployment are not performed.", "condition_status": "Met", "status_reason": "The actual retained input/version, times and current work scope have been recorded. This is not official preregistration, independent clinical certification or an up-to-date verification of the entire literature.", "missingness": "New cross-checks of external full texts/searches, content QA by another author, derived tables, UI, and shared registration/deployment are separate stages.", "uncertainty": "New cross-checks of external full texts/searches, content QA by another author, derived tables, UI, and shared registration/deployment are separate stages. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application" } ], "reports": [ { "report_id": "S01", "title": "von Siebenthal HK et al. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023;98(9):1356–1363.", "url": "https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.26987", "report_type": "Historical record of the original article's full HTML text", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": "F01", "independent_replication": false, "observed_result": "Record at the time of retention: a randomized, open-label crossover trial with 6 conditions, each involving a single exposure. There were 35 enrolled and 34 completed/analyzed participants; 204 denotes repeated observations. With the added 80 mg, median FIA was 26.7% (IQR 19.1–32.6%); without the addition, it was 20.6% (IQR 12.3–25.5%), with P<0.001 preserved. The 6.1%p, 1.296 and approximately 29.6% are historical descriptive comparisons of marginal medians, not paired/adjusted effects or a CI.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Full-text article HTML", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The current assessment's record of past full-HTML verification is not retrospectively treated as actual reading in the current work.", "material_id": "S01-M1", "url": "https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.26987", "parent_url": "https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.26987" }, { "material_type": "Full-text article PDF", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current PDF acquisition/reading history is separately unverified; it is not retrospectively treated as actual reading in the current work.", "material_id": "S01-M2", "url": null, "parent_url": "https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.26987" } ], "links": [ { "label": "Source", "url": "https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.26987" } ] }, { "report_id": "S02", "title": "PubMed bibliographic record for von Siebenthal et al. 2023", "url": "https://pubmed.ncbi.nlm.nih.gov/37357807/", "report_type": "Historical record of PubMed bibliographic information and abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": "F01", "independent_replication": false, "observed_result": "Record at the time of retention: bibliographic/abstract and indexed-notice locations for the same DOI 10.1002/ajh.26987 and PMID 37357807. This is the same article as S01 and is not counted as an independent replication.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed bibliographic information and abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Historical locations of the bibliographic header, abstract and indexed notice are not retrospectively treated as actual reading in the current work.", "material_id": "S02-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/37357807/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/37357807/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/37357807/" } ] }, { "report_id": "S03", "title": "S01 supporting information: ajh26987-sup-0001-Supinfo.docx", "url": "https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fajh.26987&file=ajh26987-sup-0001-Supinfo.docx", "report_type": "Historical access failure for S01's supplementary DOCX", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": "F01", "independent_replication": false, "observed_result": "Record at the time of retention: S01's supplementary DOCX (nominally approximately 22.1 KB) and references to S1/S2. The actual download URL in QA06 and the 403 failure at that time are preserved. Appendix content is currently unverified; the past failure is not retrospectively treated as inaccessibility this time.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Article supplementary DOCX and S1/S2", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Corrected actual download URL; the historical 403 record is not retrospectively treated as actual reading in the current work.", "material_id": "S03-M1", "url": "https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fajh.26987&file=ajh26987-sup-0001-Supinfo.docx", "parent_url": "https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fajh.26987&file=ajh26987-sup-0001-Supinfo.docx" } ], "links": [ { "label": "Source", "url": "https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fajh.26987&file=ajh26987-sup-0001-Supinfo.docx" } ] }, { "report_id": "S04", "title": "NCT04074707: Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy", "url": "https://clinicaltrials.gov/study/NCT04074707", "report_type": "Historical record of official registration index metadata", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the officially indexed title for NCT04074707 concerns oral iron absorption during pregnancy. The retained record states that this does not match the current population; the complete registration/history could not be accessed in the past. It is not confirmed as the exact official registration for S01.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Current official registration record", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Past indexed verification of the official title/first-posting metadata is not retrospectively treated as actual reading in the current work.", "material_id": "S04-M1", "url": "https://clinicaltrials.gov/study/NCT04074707", "parent_url": "https://clinicaltrials.gov/study/NCT04074707" }, { "material_type": "Official registration version history", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Past failure to access the complete record/history; the direct history URL is unverified. This is not retrospectively treated as actual reading in the current work.", "material_id": "S04-M2", "url": null, "parent_url": "https://clinicaltrials.gov/study/NCT04074707" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT04074707" } ] }, { "report_id": "S05", "title": "Hunt JR, Gallagher SK, Johnson LK. Effect of ascorbic acid on apparent iron absorption by women with low iron stores. AJCN. 1994;59:1381–1385.", "url": "https://pubmed.ncbi.nlm.nih.gov/8198064/", "report_type": "Historical location record for an article abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title concerns apparent iron absorption in women with low iron stores, and the abstract's Methods/Results/Conclusions locations are recorded. This is linked to boundaries for other comparisons, such as long-term iron balance, in the current counterview manuscript. However, the bibliography lacks individual numerical results, so no identical FIA effect or null-result numbers are added.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information and abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The abstract's Methods/Results/Conclusions are not retrospectively treated as actual reading in the current work.", "material_id": "S05-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/8198064/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/8198064/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/8198064/" } ] }, { "report_id": "S06", "title": "Hunt JR et al. Ascorbic acid: effect on ongoing iron absorption and status in iron-depleted young women. AJCN. 1990;51:649–655.", "url": "https://pubmed.ncbi.nlm.nih.gov/2321571/", "report_type": "Historical location records for an article abstract and a section of author-uploaded main text", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title concerns ongoing absorption and status in young iron-depleted women. The abstract and the Absorption of 59Fe section on p.652 of the author-uploaded main text are recorded as locations. Because the direct URL of the author's copy and individual numerical values are not currently provided, the PubMed URL is not attached as the full-text URL of the author's copy.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information and abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the abstract is not retrospectively treated as actual reading in the current work.", "material_id": "S06-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/2321571/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/2321571/" }, { "material_type": "Relevant section of the author-uploaded main text", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The direct copy URL is unverified; only the p.652 location is preserved. This is not retrospectively treated as actual reading in the current work.", "material_id": "S06-M2", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/2321571/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/2321571/" } ] }, { "report_id": "S07", "title": "Cook JD, Reddy MB. Effect of ascorbic acid intake on nonheme-iron absorption from a complete diet. AJCN. 2001;73:93–98.", "url": "https://pubmed.ncbi.nlm.nih.gov/11124756/", "report_type": "Historical location record for an article abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title concerns vitamin C intake and nonheme iron absorption from a complete diet, and the abstract location is recorded. Changes to the whole diet differ from the main comparison adding 80 mg simultaneously to the same capsule under fasted conditions. Results not provided in the current bibliography are not reconstructed.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information and abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the abstract is not retrospectively treated as actual reading in the current work.", "material_id": "S07-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/11124756/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/11124756/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/11124756/" } ] }, { "report_id": "S08", "title": "Thankachan P et al. Iron absorption in young Indian women: the interaction of iron status with the influence of tea and ascorbic acid. AJCN. 2008;87:881–886.", "url": "https://pubmed.ncbi.nlm.nih.gov/18400710/", "report_type": "Historical location records for an article abstract and indexed Methods/Table 1", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title concerns iron status and tea/ascorbic acid in young Indian women, with abstract and indexed Methods/Table 1 locations. Direct opening of the publisher's full text failed in the past. Because actual individual population/administration/numerical details are absent from the current bibliography, this is not counted as a replication of the same main comparison.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed bibliographic information, abstract/indexed methods", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Historical locations of the abstract and indexed Methods/Table 1 are not retrospectively treated as actual reading in the current work.", "material_id": "S08-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/18400710/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/18400710/" }, { "material_type": "Publisher's full-text article", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The direct publisher URL is currently unverified; the record of past failure to open the full text is not retrospectively treated as actual reading in the current work.", "material_id": "S08-M2", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/18400710/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/18400710/" } ] }, { "report_id": "S09", "title": "Cepeda-Lopez AC et al. In overweight and obese women, dietary iron absorption is reduced and the enhancement of iron absorption by ascorbic acid is one-half that in normal-weight women. AJCN. 2015;102:1389–1397.", "url": null, "report_type": "Historical location record for an institutional-repository abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title describes lower dietary iron absorption and a difference in AA enhancement in overweight/obese women. The historical location is an abstract in the authors' institutional repository; the record states that opening PubMed did not yield parsed body text. That abstract/numerical information has not been reread in the current work, and the population is not directly equated with this table's selection criteria for women.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Article abstract in an institutional repository", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The actual institutional-abstract URL is unverified and distinguished from PubMed. This is not retrospectively treated as actual reading in the current work.", "material_id": "S09-M1", "url": null, "parent_url": null }, { "material_type": "PubMed article bibliographic information", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Bibliographic URL; no parsed body text was obtained during past opening. This is not retrospectively treated as actual reading in the current work.", "material_id": "S09-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/26561622/", "parent_url": null } ], "links": [] }, { "report_id": "S10", "title": "Fidler MC et al. Iron absorption from ferrous fumarate in adult women is influenced by ascorbic acid but not by Na2EDTA. Br J Nutr. 2003.", "url": "https://pubmed.ncbi.nlm.nih.gov/14641967/", "report_type": "Historical location record for an article abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the bibliographic title concerns ferrous fumarate absorption and AA/Na2EDTA in adult women. Only the abstract location is currently retained, so no conclusion is drawn that the dose, meal, denominator or effect size is exactly the same as in this main comparison.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information and abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the abstract is not retrospectively treated as actual reading in the current work.", "material_id": "S10-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/14641967/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/14641967/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/14641967/" } ] }, { "report_id": "S11", "title": "Cercamondi CI et al. Iron bioavailability from a lipid-based complementary food fortificant mixed with millet porridge can be optimized by adding phytase and ascorbic acid but not by using a mixture of ferrous sulfate and sodium iron EDTA. J Nutr. 2013;143:1233–1239.", "url": "https://pubmed.ncbi.nlm.nih.gov/23761652/", "report_type": "Historical record of an article title and methods citation", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the title concerns lipid-based fortified foods, millet porridge and phytase/AA, and the record identifies it as a methods source cited in S01. Past opening did not yield parsed body text. This is not promoted to an independent effect result for the main comparison or to full-text verification.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information/indexed title", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Title and methods citation; no parsed body text was obtained in the past. This is not retrospectively treated as actual reading in the current work.", "material_id": "S11-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/23761652/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/23761652/" }, { "material_type": "Full-text article", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The direct full-text URL and acquisition are currently unverified. This is not retrospectively treated as actual reading in the current work.", "material_id": "S11-M2", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/23761652/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/23761652/" } ] }, { "report_id": "S12", "title": "John et al. Daily oral iron supplementation produced greater improvements in hematological parameters than alternate day doses – A pilot double-blind randomized control trial in iron-deficient young women. Clin Nutr. 2026;56:106520.", "url": "https://pubmed.ncbi.nlm.nih.gov/41354563/", "report_type": "Historical location record for an indexed abstract", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: a comparison of daily/alternate-day oral iron in young iron-deficient women, published online on 2025-11-25 and in the 2026 issue for month 1. The question concerns hematological outcomes/iron dosing schedules, not an FIA comparison adding only AA to the same iron. Publication timing is preserved only as the bibliographic record from that time.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "PubMed article bibliographic information and indexed abstract", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Online/issue publication metadata and the indexed abstract are not retrospectively treated as actual reading in the current work.", "material_id": "S12-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/41354563/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/41354563/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/41354563/" } ] }, { "report_id": "S13", "title": "NIH Office of Dietary Supplements: Vitamin C, Health Professional Fact Sheet", "url": "https://ods.od.nih.gov/factsheets/VitaminC-HealthProfessional/", "report_type": "Historical record of official general-safety web material", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "General safety background recorded at the time of retention: linked to excessive-intake risks and Table 3 in the general safety background. The retained KO UL of 2,000 mg/day for adults aged 19 years and older is neither an individual intake recommendation nor safety certification for this 80 mg condition.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Safety section/table in official NIH ODS web material", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Health Risks from Excessive Vitamin C; Table 3. This is not retrospectively treated as actual reading in the current work.", "material_id": "S13-M1", "url": "https://ods.od.nih.gov/factsheets/VitaminC-HealthProfessional/", "parent_url": "https://ods.od.nih.gov/factsheets/VitaminC-HealthProfessional/" } ], "links": [ { "label": "Source", "url": "https://ods.od.nih.gov/factsheets/VitaminC-HealthProfessional/" } ] }, { "report_id": "S14", "title": "NIDDK: Eating, Diet, & Nutrition for Hemochromatosis", "url": "https://www.niddk.nih.gov/health-information/liver-disease/hemochromatosis/eating-diet-nutrition", "report_type": "Historical record of official general-safety web material", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "General safety background recorded at the time of retention: the foods-to-avoid section of NIDDK's hemochromatosis material. General caution about iron overload is not converted into direct AE counts in young nonanemic women or into individual safety.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Diet/cautions section in official NIDDK web material", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The relevant hemochromatosis diet/nutrition section is not retrospectively treated as actual reading in the current work.", "material_id": "S14-M1", "url": "https://www.niddk.nih.gov/health-information/liver-disease/hemochromatosis/eating-diet-nutrition", "parent_url": "https://www.niddk.nih.gov/health-information/liver-disease/hemochromatosis/eating-diet-nutrition" } ], "links": [ { "label": "Source", "url": "https://www.niddk.nih.gov/health-information/liver-disease/hemochromatosis/eating-diet-nutrition" } ] }, { "report_id": "S15", "title": "National Cancer Institute: Intravenous Vitamin C (PDQ), Health Professional Version", "url": "https://www.cancer.gov/about-cancer/treatment/cam/hp/vitamin-c-pdq", "report_type": "Historical record of official general-safety web material", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "General safety background recorded at the time of retention: the Adverse Effects location in NCI's intravenous vitamin C PDQ. The retained KO distinguishes the high-dose intravenous/G6PD context from direct application to the 80 mg oral trial.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Intravenous vitamin C safety section in official NCI web material", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The different route/dose context of Adverse Effects is not retrospectively treated as actual reading in the current work.", "material_id": "S15-M1", "url": "https://www.cancer.gov/about-cancer/treatment/cam/hp/vitamin-c-pdq", "parent_url": "https://www.cancer.gov/about-cancer/treatment/cam/hp/vitamin-c-pdq" } ], "links": [ { "label": "Source", "url": "https://www.cancer.gov/about-cancer/treatment/cam/hp/vitamin-c-pdq" } ] }, { "report_id": "S16", "title": "IAEA. Assessment of Iron Bioavailability in Humans Using Stable Iron Isotope Techniques. Human Health Series 21. Vienna, 2012. STI/PUB/1544.", "url": "https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1544_web.pdf", "report_type": "Historical record of relevant sections/figures in the IAEA methods PDF", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: IAEA 2012 Human Health Series 21, §7.4 pp.37–38/PDF48–49 equation 18, and §8.1 pp.39–40/figure p.40. This is methodological background for isotope dilution/incorporation models, not a new clinical replication or verification of individual incorporation fractions in this population.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Relevant sections and figures in the IAEA methods PDF", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Historical locations in §7.4/8.1, equation 18 and the corresponding pages are not retrospectively treated as actual reading in the current work.", "material_id": "S16-M1", "url": "https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1544_web.pdf", "parent_url": "https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1544_web.pdf" } ], "links": [ { "label": "Source", "url": "https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1544_web.pdf" } ] }, { "report_id": "S17", "title": "NCT05414474: Effects of Enhancers and Inhibitors on Absorption From Iron Supplements (IDEA)", "url": null, "report_type": "Historical provisional link to a registration-data mirror", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the Veeva registration-data mirror for NCT05414474 was linked by inference because of the same 6 conditions, investigators and enrollment. Official version history is unverified. Because the actual mirror URL is unavailable, the official ClinicalTrials.gov URL is not attached as though it were the mirror's original text.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Veeva registration-data mirror", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The actual mirror URL is unverified and distinguished from the official URL. This is not retrospectively treated as actual reading in the current work.", "material_id": "S17-M1", "url": null, "parent_url": null }, { "material_type": "Current official registration record", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Bibliographic reference to the official canonical URL; this does not verify current or past official content. It is not retrospectively treated as actual reading in the current work.", "material_id": "S17-M2", "url": "https://clinicaltrials.gov/study/NCT05414474", "parent_url": null }, { "material_type": "Official registration version history", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Past access failure and an unverified direct history URL are not retrospectively treated as actual reading in the current work.", "material_id": "S17-M3", "url": null, "parent_url": null } ], "links": [] }, { "report_id": "S18", "title": "NCT06822062: Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption (INSECTE)", "url": "https://clinicaltrials.gov/study/NCT06822062", "report_type": "Historical record of an officially indexed registration plan", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the indexed Study Plan location for NCT06822062 INSECTE (meals A–G, primary outcome). This is a registered plan, not counted as a completed result matching the current main comparison or an independent replication.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Current official registration record/plan", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the indexed Study Plan is not retrospectively treated as actual reading in the current work.", "material_id": "S18-M1", "url": "https://clinicaltrials.gov/study/NCT06822062", "parent_url": "https://clinicaltrials.gov/study/NCT06822062" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT06822062" } ] }, { "report_id": "S19", "title": "Does consuming ascorbate-rich fruits and fruit juices with meals improve iron bioavailability? 2026 review discovery", "url": "https://www.sciencedirect.com/science/article/pii/S0002916526002273", "report_type": "Historical discovery of an indexed review title", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: an indexed title discovered for a 2026 fruit/juice review, with the full text recorded as not acquired. Because the included-trial table and individual effects are currently unavailable, this is not promoted to an independent absorption-trial result or to reading of the complete review.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Indexed review title/bibliographic information", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the indexed discovery is not retrospectively treated as actual reading in the current work.", "material_id": "S19-M1", "url": "https://www.sciencedirect.com/science/article/pii/S0002916526002273", "parent_url": "https://www.sciencedirect.com/science/article/pii/S0002916526002273" }, { "material_type": "Full review text and included-trial table", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Full text not acquired; the direct full-text file URL is unverified. This is not retrospectively treated as actual reading in the current work.", "material_id": "S19-M2", "url": null, "parent_url": "https://www.sciencedirect.com/science/article/pii/S0002916526002273" } ], "links": [ { "label": "Source", "url": "https://www.sciencedirect.com/science/article/pii/S0002916526002273" } ] }, { "report_id": "S20", "title": "Iron Absorption from a Dietary Supplement, FeHydroA registry lead", "url": null, "report_type": "Registration lead with unresolved exact URL", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: an indexed title lead for FeHydroA, with the exact record URL unresolved. A portal homepage is neither a link to that actual registration record nor evidence of results.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Exact FeHydroA registration record", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The exact record URL is unresolved; the portal homepage is a separate bibliographic reference. This is not retrospectively treated as actual reading in the current work.", "material_id": "S20-M1", "url": null, "parent_url": null } ], "links": [] }, { "report_id": "S21", "title": "Effects of reducing chronic inflammation in overweight women on serum hepcidin and iron absorption with and without supplemental ascorbic acid. Br J Nutr. 2020 online.", "url": "https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/effects-of-reducing-chronic-inflammation-in-overweight-women-on-serum-hepcidin-and-iron-absorption-with-and-without-supplemental-ascorbic-acid/2F88A24542B08DE1D5B7F56B9E3B56D1", "report_type": "Historical lead from an indexed study description", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: an indexed study description concerning reduced chronic inflammation, hepcidin and absorption with/without AA in overweight women. No full-text verification of actual endpoints, exposure or numbers is added, and it is not merged into the same direct main comparison in a population with low inflammation and a restricted BMI range.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Publisher's indexed study description/bibliographic information", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical location of the retained indexed description is not retrospectively treated as actual reading in the current work.", "material_id": "S21-M1", "url": "https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/effects-of-reducing-chronic-inflammation-in-overweight-women-on-serum-hepcidin-and-iron-absorption-with-and-without-supplemental-ascorbic-acid/2F88A24542B08DE1D5B7F56B9E3B56D1", "parent_url": "https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/effects-of-reducing-chronic-inflammation-in-overweight-women-on-serum-hepcidin-and-iron-absorption-with-and-without-supplemental-ascorbic-acid/2F88A24542B08DE1D5B7F56B9E3B56D1" } ], "links": [ { "label": "Source", "url": "https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/effects-of-reducing-chronic-inflammation-in-overweight-women-on-serum-hepcidin-and-iron-absorption-with-and-without-supplemental-ascorbic-acid/2F88A24542B08DE1D5B7F56B9E3B56D1" } ] }, { "report_id": "P907", "title": "Supplied completed verdict 907: vitamin C plus oral iron and additional hemoglobin recovery", "url": "https://chamgap.com/v/907/", "report_type": "Historical reference to an existing assessment/sealed input", "existence": "Limited to the level recorded in the current bibliography and retained manuscript. A separate extract from the original sources.json is not included in this input.", "acquired_read": "Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.", "study_family": null, "independent_replication": false, "observed_result": "Record at the time of retention: the existing 907 addresses additional Hb recovery with vitamin C+oral iron. QA01 is preserved: this was not treated as a duplicate of the FIA table solely because of the same ingredient/route. The separate 907 input and public page were not opened this time.", "result_level": "Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.", "materials": [ { "material_type": "Public page for an existing Chamgap assessment", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The historical reference to the public assessment URL is not retrospectively treated as actual reading in the current work.", "material_id": "P907-M1", "url": "https://chamgap.com/v/907/", "parent_url": "https://chamgap.com/v/907/" }, { "material_type": "Sealed copy of the existing assessment input", "public_status": "Unverified (no external lookup this time)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The separate 907.json is absent from the current input and was not read this time. It is not retrospectively treated as actual reading in the current work.", "material_id": "P907-M2", "url": null, "parent_url": "https://chamgap.com/v/907/" } ], "links": [ { "label": "Source", "url": "https://chamgap.com/v/907/" } ] } ], "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 criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification." }, { "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 and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification." }, { "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": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification." }, { "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": "Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification." }, { "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": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification." } ], "status_dictionary": { "Met": "Fulfillment of narrow documentation criteria, such as question/attribution, historical calculations, current versus past reading and versions. This is not clinical efficacy/safety certification or current verification of external full texts.", "Partly verified": "Actual retained reports exist, but verification of the relevant material remains outstanding, including original methods/plans, denominators/intervals and identity/access checks.", "Unverified": "Necessary materials/values cannot be established within the current input and the scope of verification at that time. This does not mean absence of new studies or an effect of 0.", "Not reported": "Limited to a record of nonreporting in a specific material/section actually read or in an explicitly identified historical summary. It is not extended to the entirety of external full texts not read this time.", "Conflicting information": "Incompatible records of the same fact retained in the current input. Here, these concern historical conflicts involving registration numbers and QA04, not a new cross-check or resolution against original texts.", "Inaccessible": "Used only when external access has actually failed this time. Because access is not attempted in this work, historical 403/failure records are not inherited as current status.", "Review incomplete": "Limited to review that actually remains outstanding or external materials not cross-checked this time. It does not mark all review of the retained stored summary as incomplete when that review has already been completed.", "Not applicable": "Confirmation for other populations, long-term use, clinical outcomes or individual safety does not apply to this table's narrow FIA question. This does not constitute absence of research, a null effect or safety certification for each extension." }, "study_overlap": { "state": "These are report links in the stored manuscript. Main text, index and supplementary material for the same article (S01, S02, S03) / A probable registration-mirror link for F01, not confirmed through official version history (S17) / Related articles, methodological/safety explanations, registrations, reviews and an existing assessment. Without a current individual family table, these are not automatically added to the number of directly eligible unique families (S04, S05, S06, S07, S08, S09, S10, S11, S12, S13, S14, S15, S16, S18, S19, S20, S21, P907). The overall number of unique trials and total participant count are unverified. Verification of the retained summary is distinguished from not having read the original materials this time; report/family labels are not summed into total trial or participant counts.", "unique_trial_count": null, "unique_participant_count": null, "reason": "These are report links in the stored manuscript. Main text, index and supplementary material for the same article (S01, S02, S03) / A probable registration-mirror link for F01, not confirmed through official version history (S17) / Related articles, methodological/safety explanations, registrations, reviews and an existing assessment. Without a current individual family table, these are not automatically added to the number of directly eligible unique families (S04, S05, S06, S07, S08, S09, S10, S11, S12, S13, S14, S15, S16, S18, S19, S20, S21, P907). The overall number of unique trials and total participant count are unverified. Verification of the stored summary is distinguished from not having read the original materials this time; report/family labels are not summed into total trial or participant counts." }, "history": [ { "date": "2026-11-06", "kind": "Separation of public-facing display and data", "view_version": "1.0", "change": "Public-facing display and data were produced from the existing 38 items. No new clinical searches, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-11-06" }