{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v3113-main",
  "verdict_number": "3113",
  "title": "Oral cyanocobalamin ampule regimen × Day-90 hemoglobin in B12-deficiency megaloblastic anemia versus intramuscular administration of the same compound",
  "view_version": "1.0",
  "view_created_date": "2026-11-05",
  "criteria_version": "NGM-v3113-CYANO-AMPULE-JUICE-IM-HB90-1.1",
  "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": "External clinical abstracts, full texts, registry records and analysis plans were not newly read. Reading the stored summaries is distinguished from not reading 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": "Actual participants were nonpregnant, nonlactating adults aged 32–87, with B12<160pg/mL, megaloblastic anemia and MCV>94fL; Hb<12g/dL in the analyzed groups. Mixed dietary causes/gastritis or suspected malabsorption/unverified causes; Hb results not separated by cause; normal folate, iron status not reported",
    "intervention": "Contents of a Dodex(Deva,Turkey)1000mcg ampule mixed into 20mL of fruit juice and swallowed; not a tablet; additional salt and release specifications not reported",
    "dose": "Both arms: 1 time at 1000mcg, daily for 10 days→1 time per week for 4 weeks→1 time per month; subtotal for the first 14 administrations 14000mcg, total over 90 days unverified",
    "comparator": "Dodex1000mcg intramuscular injection, with the same loading, weekly and monthly schedule; common additional anemia treatment in both arms not reported; fruit juice specified only for the oral arm",
    "endpoint": "Day-90 Hb(g/dL), one of the article-stated primary endpoints; endpoint mean difference and reconstructed CI. Adjusted endpoint difference/change-difference CI and the registered primary-time hierarchy unverified",
    "duration": "Observation for 90 days; a lifelong plan of 1 time per month is not lifelong observation",
    "excluded_extensions": [
      "Oral tablets/sublingual, intranasal or intravenous administration/other B12 chemical forms",
      "B12 treatment effects versus no treatment/placebo",
      "Substituting serum B12 normalization or Hct alone for Hb",
      "The general population with normal B12, children, pregnancy/lactation, or confirmed pernicious anemia as a specific cause",
      "Extending a lifelong treatment plan to lifelong observation/optimal dosing",
      "Claims of formal equivalence/noninferiority or an effect of 0"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Independent claim",
      "question": "Which actual B12 regimens are being compared for day-90 Hb?",
      "needed": "The original question of day-90 Hb in adults with laboratory-confirmed B12-deficiency megaloblastic anemia: oral ampule+fruit juice versus the same compound IM",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid combining general B12 treatment, effects versus no treatment and all oral products into the same claim.",
      "application_exception": "Retain the original narrowed question and empty subclaims list; do not generate a separate combination of axes.",
      "criterion": "Link the original independent claim to the actual regimen, population, active comparator, endpoint and direction.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Identify direct comparisons within this boundary, and treat other forms, populations and endpoints as separate questions.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The question is whether the actual oral regimen of swallowing Dodex cyanocobalamin ampule+fruit juice raises day-90 Hb more than same-schedule IM in adults with B12-deficiency megaloblastic anemia. The subclaims list is actually empty. Efficacy versus no treatment, equivalence and noninferiority were not made the question.",
      "condition_status": "Met",
      "status_reason": "Verification that the boundary is preserved; not establishment of superiority or certification of efficacy for all B12 products.",
      "missingness": "Verification that the boundary is preserved; not establishment of superiority or certification of efficacy for all B12 products.",
      "uncertainty": "Verification that the boundary is preserved; not establishment of superiority or certification of efficacy for all B12 products.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The original question of day-90 Hb in adults with laboratory-confirmed B12-deficiency megaloblastic anemia: oral ampule+fruit juice versus the same compound IM"
    },
    {
      "item_id": "N02",
      "question_type": "Chemical form and product",
      "question": "Is the cyanocobalamin product distinguished from unverified manufacturing details?",
      "needed": "Documentation of the original Dodex/Deva product's active ingredient, manufacturing origin, batch, purity, additional salt and release specifications",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid filling gaps in the original product's identity with data on other cobalamins and tablets.",
      "application_exception": "Do not transfer information on methyl/meco, hydroxo or adenosyl B12 or separately authorized products as if they were the same product.",
      "criterion": "Preserve the reported Dodex1000mcg cyanocobalamin and the unreported manufacturing/formulation details separately.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare the original trial product documentation and batch/ingredient records with actual administration records.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Retained S01 specifies Dodex(Deva, Turkey) cyanocobalamin 1000mcg ampules. Manufacturing origin, batch, purity, additional salt and release specifications are not reported. Other B12 chemical forms and oral tablets were not substituted.",
      "condition_status": "Partly verified",
      "status_reason": "The product/ingredient is reported, but manufacturing, batch, additional chemical-form/release details and a current comparison with the original PDF remain unverified.",
      "missingness": "The product/ingredient is reported, but manufacturing, batch, additional chemical-form/release details and a current comparison with the original PDF remain unverified.",
      "uncertainty": "The product/ingredient is reported, but manufacturing, batch, additional chemical-form/release details and a current comparison with the original PDF remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Documentation of the original Dodex/Deva product's active ingredient, manufacturing origin, batch, purity, additional salt and release specifications"
    },
    {
      "item_id": "N03",
      "question_type": "Actual route and physical formulation",
      "question": "Is oral ampule+fruit juice being read as a tablet comparison or an isolated-route comparison?",
      "needed": "The original S01 section on oral ampule contents/20mL fruit juice, the same IM product and actual administration methods",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid changing the swallowing method and administration context into another product/route.",
      "application_exception": "This is the actual regimen including fruit juice; pharmacokinetic equivalence of the routes requires separate evidence.",
      "criterion": "Attribute the oral arm's ampule+fruit juice and nurse-administered IM to the actual comparison.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check the original administration section and product records, and design an isolated-route/formulation comparison separately.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The retained original regimen compares oral administration of the same cyanocobalamin ampule contents mixed into 20mL fruit juice and swallowed with IM administration. It is not a tablet, sublingual, intranasal or intravenous regimen. Fruit juice is specified only for the oral arm, so this does not establish pharmacokinetic equivalence of the routes in isolation.",
      "condition_status": "Met",
      "status_reason": "Verification of the criterion distinguishing the currently retained regimens. This is not new verification of the original administration documents or pharmacokinetics.",
      "missingness": "Verification of the criterion distinguishing the currently retained regimens. This is not new verification of the original administration documents or pharmacokinetics.",
      "uncertainty": "Verification of the criterion distinguishing the currently retained regimens. This is not new verification of the original administration documents or pharmacokinetics.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The original S01 section on oral ampule contents/20mL fruit juice, the same IM product and actual administration methods"
    },
    {
      "item_id": "N04",
      "question_type": "Nominal dose and cumulative dose",
      "question": "Is the 1000mcg schedule distinguished from the exact 90-day total?",
      "needed": "Nominal dose for 1 time in each arm, daily/weekly/monthly schedules, administration dates throughout 90 days and actual total dose",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the subtotal for the first 14 administrations into the full 90-day dose or a personal recommendation.",
      "application_exception": "Preserve the historical subtotal of 14000mcg unchanged; do not perform new conversions or calculations in this review.",
      "criterion": "Show 1000mcg daily for 10 days→1 time per week for 4 weeks→1 time per month separately from the unverified total dose.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Link original prescription/administration dates and actual doses taken in each arm to the time points and denominators.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The nominal schedule for both arms is 1 time at 1000mcg, daily for 10 days→1 time per week for 4 weeks→1 time per month. The 14000mcg for the first 14 administrations is the historical subtotal; the exact 90-day cumulative dose remains unverified. No cumulative-dose calculation or recommended dose was created in this review.",
      "condition_status": "Partly verified",
      "status_reason": "The nominal dose/schedule is retained, but exact administration dates and total dose over 90 days, and actual exposure, have not been verified.",
      "missingness": "The nominal dose/schedule is retained, but exact administration dates and total dose over 90 days, and actual exposure, have not been verified.",
      "uncertainty": "The nominal dose/schedule is retained, but exact administration dates and total dose over 90 days, and actual exposure, have not been verified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Nominal dose for 1 time in each arm, daily/weekly/monthly schedules, administration dates throughout 90 days and actual total dose"
    },
    {
      "item_id": "N05",
      "question_type": "Actual adherence and concurrent exposure",
      "question": "Have actual doses taken and dietary/concurrent B12 been verified?",
      "needed": "Arm-specific adherence/missed administrations, diet, fortified foods, concurrent B12 and exposure records and analyses",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting planned administration into equal actual exposure or complete adherence.",
      "application_exception": "Do not infer 100% adherence or PP if quantitative adherence is not stated in the original source.",
      "criterion": "Keep nominal exposure separate from gaps in verification of actual adherence and concurrent exposure.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare arm-specific dosing/missed administrations and dietary/concurrent exposure with the effects of assignment/adherence.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Quantitative adherence and total dietary, fortified-food and concurrent B12 exposure could not be verified in the retained source. The planned schedule alone was not described as verifying balance in actual exposure or the effect of adherence.",
      "condition_status": "Unverified",
      "status_reason": "The link between actual exposure/adherence and the analysis remains unverified.",
      "missingness": "The link between actual exposure/adherence and the analysis remains unverified.",
      "uncertainty": "The link between actual exposure/adherence and the analysis remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Arm-specific adherence/missed administrations, diet, fortified foods, concurrent B12 and exposure records and analyses"
    },
    {
      "item_id": "N06",
      "question_type": "Observation period",
      "question": "Is 90-day observation separated from the lifelong monthly plan?",
      "needed": "Distinguishing S01 administration, visits/end of observation and monthly maintenance plans from actual follow-up",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid extending an administration plan to observation, efficacy or safety throughout that period.",
      "application_exception": "Do not require a lifelong efficacy trial for the selected 90-day question.",
      "criterion": "Record 90-day observation and the lifelong plan of 1 time per month separately.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "When asking about maintenance or effects after discontinuation, obtain actual long-term follow-up and its denominators separately.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Observation lasted 90 days. A lifelong administration plan of 1 time per month is not a record of lifelong observation. This question and the original values were restricted to 90 days.",
      "condition_status": "Met",
      "status_reason": "Verification of the boundary between the retained plan and observation; not verification of long-term efficacy or safety.",
      "missingness": "Verification of the boundary between the retained plan and observation; not verification of long-term efficacy or safety.",
      "uncertainty": "Verification of the boundary between the retained plan and observation; not verification of long-term efficacy or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Distinguishing S01 administration, visits/end of observation and monthly maintenance plans from actual follow-up"
    },
    {
      "item_id": "N07",
      "question_type": "Actual population and cutoffs",
      "question": "Which adults with B12-deficiency anemia were compared?",
      "needed": "Inclusion/exclusion for ages 32–87, nonpregnant/nonlactating status, B12<160pg/mL, MCV>94fL, megaloblastic anemia and Hb<12 in the analyzed groups",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid applying the result to the general population with normal B12, children or pregnant/lactating groups.",
      "application_exception": "Do not generalize the laboratory cutpoints and Hb in the analyzed groups into criteria for all patients with anemia.",
      "criterion": "Describe the population actually reported and the question's boundaries, with each laboratory measure and unit.",
      "basis": "M03 §3.2.1; detailed population criteria are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Link original eligibility, baseline distributions and exclusions to the actual denominators of the direct comparison.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The actual S01 participants were nonpregnant, nonlactating adults aged 32–87, reported to have B12<160pg/mL, MCV>94fL and megaloblastic anemia; baseline Hb in the analyzed groups was <12g/dL. This was not extended to the general population with normal B12, children or pregnancy/lactation.",
      "condition_status": "Met",
      "status_reason": "Verification of the retained population definition; this does not imply the same effect in all adults or special populations.",
      "missingness": "Verification of the retained population definition; this does not imply the same effect in all adults or special populations.",
      "uncertainty": "Verification of the retained population definition; this does not imply the same effect in all adults or special populations.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Inclusion/exclusion for ages 32–87, nonpregnant/nonlactating status, B12<160pg/mL, MCV>94fL, megaloblastic anemia and Hb<12 in the analyzed groups"
    },
    {
      "item_id": "N08",
      "question_type": "Causes and iron/folate status",
      "question": "Is the entire cohort being called confirmed pernicious anemia, or are cause-specific Hb results being invented?",
      "needed": "Dietary/gastric, malabsorption and unverified causes; intrinsic-factor testing, iron/folate status and cause-specific Hb",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting mixed causes into a single confirmed diagnosis or a common effect across all causes.",
      "application_exception": "Do not convert the retained record that intrinsic-factor testing was not performed into absence of pernicious anemia.",
      "criterion": "Separate normal folate from unverified iron status and cause-specific Hb, and distinguish the mixed diagnoses.",
      "basis": "M03 §3.2.1; detailed population criteria are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Review causes/baseline tests and prespecified stratified Hb comparisons with the actual denominators.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Dietary and gastric causes, suspected malabsorption and unverified causes are mixed. Intrinsic-factor testing was not performed, and the entire cohort was not described as confirmed pernicious anemia. Folate was reported as normal, but iron status and cause-specific Hb were not reported.",
      "condition_status": "Partly verified",
      "status_reason": "Mixed causes and folate information are retained, but confirmation by cause, iron status and Hb comparisons remain unverified.",
      "missingness": "Mixed causes and folate information are retained, but confirmation by cause, iron status and Hb comparisons remain unverified.",
      "uncertainty": "Mixed causes and folate information are retained, but confirmation by cause, iron status and Hb comparisons remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Dietary/gastric, malabsorption and unverified causes; intrinsic-factor testing, iron/folate status and cause-specific Hb"
    },
    {
      "item_id": "N09",
      "question_type": "Comparator, concomitant treatment and rescue treatment",
      "question": "Can the same IM schedule be distinguished from common anemia treatment?",
      "needed": "Actual records of the same Dodex IM, arm-specific iron/folate/transfusion/EPO, rescue treatment/changes, adherence and fruit juice",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid attributing differences in concomitant treatment to the contribution of oral B12 itself.",
      "application_exception": "Do not write that common treatment was absent because it was not reported, or require all changes to be identical.",
      "criterion": "Distinguish the same active ingredient/nominal schedule from unverified concomitant treatment and actual exposure in each arm.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare arm-specific background treatment, changes/rescue records and the analysis of the Hb effect of interest.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The active comparator is the same Dodex1000mcg IM with the same loading/weekly/monthly schedule. Iron, folate, transfusion, erythropoietin and rescue treatment remain unverified; fruit juice is specified only for oral administration. This was not converted into an untreated comparator.",
      "condition_status": "Partly verified",
      "status_reason": "The actual active comparator is retained, but balance in background/rescue treatment between arms and the oral regimen's contribution remain unverified.",
      "missingness": "The actual active comparator is retained, but balance in background/rescue treatment between arms and the oral regimen's contribution remain unverified.",
      "uncertainty": "The actual active comparator is retained, but balance in background/rescue treatment between arms and the oral regimen's contribution remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Actual records of the same Dodex IM, arm-specific iron/folate/transfusion/EPO, rescue treatment/changes, adherence and fruit juice"
    },
    {
      "item_id": "N10",
      "question_type": "Hb measurement",
      "question": "Is the objectivity of Hb the same as verification of actual testing and assessor blinding?",
      "needed": "Hb(g/dL) assay method/time points, measurements by arm, analyst blinding and missing measurements/errors",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid claiming that Hb measurement bias is resolved by the name of an objective test or by endoscopy blinding.",
      "application_exception": "Do not automatically convert unverified blinding into measurement error or trial failure.",
      "criterion": "Separate objective Hb from unverified assessor/arm-specific measurement conditions.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.4; internally defined boundaries for extending the claim",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare the original assay section with Hb assessment/time points and denominators by arm.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Hb is an objective laboratory measure in g/dL, but Hb analyst blinding remains unverified. Endoscopy blinding was not transferred to Hb assessment. Hb is distinct from fatigue, transfusion, death and daily functioning.",
      "condition_status": "Partly verified",
      "status_reason": "The endpoint/unit is available, but comparison against the original source for Hb testing implementation, assessors and arm-specific measurement limitations is incomplete.",
      "missingness": "The endpoint/unit is available, but comparison against the original source for Hb testing implementation, assessors and arm-specific measurement limitations is incomplete.",
      "uncertainty": "The endpoint/unit is available, but comparison against the original source for Hb testing implementation, assessors and arm-specific measurement limitations is incomplete.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Hb(g/dL) assay method/time points, measurements by arm, analyst blinding and missing measurements/errors"
    },
    {
      "item_id": "N11",
      "question_type": "Endpoint and day-90 hierarchy",
      "question": "Is an article-stated primary Hb endpoint the same as a registry-verified unique primary visit?",
      "needed": "Original Response Criteria/table, CBC visit list and endpoint/time-point hierarchy in the registry/protocol/SAP",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the article's last visit into the unique preregistered primary time point.",
      "application_exception": "Disclose the difference between the abbreviated CBC list and the day-90 table, but do not establish selective reporting on the basis of an unavailable plan.",
      "criterion": "Distinguish Hb as one of the primary endpoints and the final day-90 visit from the unverified registry hierarchy.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare the original plan/visit schedule and registry amendment history with the actually reported day-90 assessment.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Hb is one of the article-stated primary endpoints, and day 90 is the last planned and reported response assessment. It is not a registry-verified unique prespecified primary time point. The difference whereby day 90 is absent from the abbreviated Methods CBC visit list but present in the response criteria/table at day 90 is preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Timing information is available in the article/table, but verification against the plan of the prespecified hierarchy, multiplicity and differences in the lists remains incomplete.",
      "missingness": "Timing information is available in the article/table, but verification against the plan of the prespecified hierarchy, multiplicity and differences in the lists remains incomplete.",
      "uncertainty": "Timing information is available in the article/table, but verification against the plan of the prespecified hierarchy, multiplicity and differences in the lists remains incomplete.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original Response Criteria/table, CBC visit list and endpoint/time-point hierarchy in the registry/protocol/SAP"
    },
    {
      "item_id": "N12",
      "question_type": "Arm-specific Hb and SD",
      "question": "Are arm-specific Hb means/SDs at baseline and day 90 linked without changing their values?",
      "needed": "Oral/IM baseline and day-90 means(SD), g/dL and analyzed denominators 26/34 in the original S01 table",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid confusing baseline with endpoint, SD with SE or between-group with within-group results, or converting rounded values into high-precision original values.",
      "application_exception": "The retained numbers are not the results of a current visual comparison with the original PDF or of new calculations.",
      "criterion": "Preserve the four arm-specific means/SDs with their correct time points, units and denominators.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "When checking the original table/transcription's numbers, definitions of dispersion and denominators at each time point, preserve and compare all before/after values.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Retained Hb mean(SD) values are oral baseline 8.4(2.1)→day 90 13.8(0.7), and IM 8.3(2.3)→13.7(0.9) g/dL. The analyzed denominators are oral 26/IM 34; SD was not changed to SE, and no new calculations were performed.",
      "condition_status": "Met",
      "status_reason": "Verification of exact preservation and attribution of the numbers; not a visual verification of the publisher PDF in this review.",
      "missingness": "Verification of exact preservation and attribution of the numbers; not a visual verification of the publisher PDF in this review.",
      "uncertainty": "Verification of exact preservation and attribution of the numbers; not a visual verification of the publisher PDF in this review.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Oral/IM baseline and day-90 means(SD), g/dL and analyzed denominators 26/34 in the original S01 table"
    },
    {
      "item_id": "N13",
      "question_type": "Unadjusted endpoint difference",
      "question": "For which between-group effect is +0.10g/dL the retained calculation?",
      "needed": "Direction and calculation provenance of the unadjusted day-90 endpoint mean difference, and absence of the prioritized adjusted/change effect",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting an editorial reconstruction into an originally reported adjusted effect or a registered analysis.",
      "application_exception": "Preserve the historical +0.10; do not perform a Mann–Whitney/NI analysis or recalculation in this review.",
      "criterion": "Explain its provenance as oral−IM, day-90 endpoint values, unadjusted, and a historical editorial substitute.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If the original adjusted/change estimand becomes available, compare its definition and values in a separate version.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Oral−IM +0.10g/dL is the historically reconstructed unadjusted day-90 endpoint mean difference. It was explicitly substituted because the prioritized adjusted/change estimate was unavailable; it was not labeled a prespecified NI analysis or the original Mann–Whitney test.",
      "condition_status": "Met",
      "status_reason": "Verification that the existing calculation's definition and provenance are preserved; not a new efficacy calculation or certification of a prespecified analysis.",
      "missingness": "Verification that the existing calculation's definition and provenance are preserved; not a new efficacy calculation or certification of a prespecified analysis.",
      "uncertainty": "Verification that the existing calculation's definition and provenance are preserved; not a new efficacy calculation or certification of a prespecified analysis.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Direction and calculation provenance of the unadjusted day-90 endpoint mean difference, and absence of the prioritized adjusted/change effect"
    },
    {
      "item_id": "N14",
      "question_type": "Within-group change and causality",
      "question": "Are +5.4 in both arms and a rounded change difference of 0 being read as no effect/equivalence?",
      "needed": "Rounded within-group changes, between-group effects, change variance/CI and definition of the comparison",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting improvement in both arms into efficacy versus no treatment or verified equivalence.",
      "application_exception": "The historical 5.4/5.4 and 0 are descriptive only; do not create a new test of the difference in changes.",
      "criterion": "Distinguish within-group changes and the rounded change difference from the active-comparator interpretation currently possible.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check the original change-score variance/between-group CI and analysis, and review them separately from endpoint-value results.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Rounded within-group mean increases are approximately +5.4g/dL in both arms; the rounded change difference of 0 is descriptive. Within-group improvement is not an effect versus no treatment, and a change difference of 0 does not verify equivalence or no effect. The corresponding establishment flags in the original interpretation are false.",
      "condition_status": "Met",
      "status_reason": "Verification of the criteria for preserving interpretive boundaries and historical values; not a reassessment of the clinical conclusion.",
      "missingness": "Verification of the criteria for preserving interpretive boundaries and historical values; not a reassessment of the clinical conclusion.",
      "uncertainty": "Verification of the criteria for preserving interpretive boundaries and historical values; not a reassessment of the clinical conclusion.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Rounded within-group changes, between-group effects, change variance/CI and definition of the comparison"
    },
    {
      "item_id": "N15",
      "question_type": "Adjusted and change estimates",
      "question": "Were the adjusted endpoint difference and change-score uncertainty reported?",
      "needed": "Baseline-adjusted endpoint effect/model, change SD/CI, analysis population and handling of missing data",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid arbitrarily calculating a change SD or adjusted effect from the endpoint SD.",
      "application_exception": "Do not expand an empty value into 0, equivalence or a statement that the item is unreported throughout the original article's full text.",
      "criterion": "Preserve the current empty values for the adjusted effect, change CI and exact between-group P, together with the original scope of access.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Obtain the original analysis/supplement, arm-specific paired-change variance/covariance and handling of missing data.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "adjusted_effect, change_score_CI and reported_exact_between_group_P are empty. Baseline adjustment, change variance and P values were not calculated in this review. The unadjusted endpoint reconstruction does not resolve these gaps.",
      "condition_status": "Unverified",
      "status_reason": "The original values/definitions of the prioritized adjusted/change analysis and exact between-group test remain unverified.",
      "missingness": "The original values/definitions of the prioritized adjusted/change analysis and exact between-group test remain unverified.",
      "uncertainty": "The original values/definitions of the prioritized adjusted/change analysis and exact between-group test remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Baseline-adjusted endpoint effect/model, change SD/CI, analysis population and handling of missing data"
    },
    {
      "item_id": "N16",
      "question_type": "Reconstructed CI",
      "question": "Are the exact values, provenance and interpretive limitations of the 95% CI preserved?",
      "needed": "C02 editor-reconstructed endpoint-difference CI, original arm-specific SDs/denominators, calculation conditions and clinically important difference",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting a calculated interval into a CI reported in the original article or into exclusion of meaningful benefit.",
      "application_exception": "Preserve the historical exact values [-0.313492,0.513492] and display −0.31~+0.51; do not recalculate them in this review.",
      "criterion": "Explain the editor-reconstructed 95%CI, inclusion of 0/differences in both directions and the unverified important margin together.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If the original estimate/interval and calculation definition become available, separately compare arm-specific denominators/dispersion and clinical criteria.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The historical exact values of editor_reconstructed_CI95 are [-0.313492,0.513492]g/dL, displayed as −0.31~+0.51. This is not the original Mann–Whitney/NI analysis; it includes 0 and differences in both directions. Without a clinical margin, it does not exclude meaningful benefit.",
      "condition_status": "Partly verified",
      "status_reason": "The reconstructed interval is retained, but the originally reported/adjusted and change intervals and a justified clinically important difference remain unverified.",
      "missingness": "The reconstructed interval is retained, but the originally reported/adjusted and change intervals and a justified clinically important difference remain unverified.",
      "uncertainty": "The reconstructed interval is retained, but the originally reported/adjusted and change intervals and a justified clinically important difference remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "C02 editor-reconstructed endpoint-difference CI, original arm-specific SDs/denominators, calculation conditions and clinically important difference"
    },
    {
      "item_id": "N17",
      "question_type": "Clinical importance",
      "question": "Is there a verified Hb MCID/important difference?",
      "needed": "A justified important between-group difference for the selected B12-deficiency anemia, day-90 Hb and active comparator",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting effect magnitude under statistical conventions into importance to patients or failure to meet an MCID.",
      "application_exception": "Do not arbitrarily adopt a common minimum number of participants, duration or trial count as a sufficiency criterion.",
      "criterion": "Distinguish the empty verified_between_group_MCID value from the existing statistical magnitude code.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Obtain evidence of importance for this population/scale/time point and compare it separately with the relevant effect/CI.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "verified_between_group_MCID is empty. Historical Hedges g0.12039708 or E~ represents magnitude under statistical conventions only; it does not verify failure to meet an MCID, a clinically positive result or exclusion of important benefit.",
      "condition_status": "Unverified",
      "status_reason": "A justified clinical-importance criterion for the selected between-group Hb difference remains unverified.",
      "missingness": "A justified clinical-importance criterion for the selected between-group Hb difference remains unverified.",
      "uncertainty": "A justified clinical-importance criterion for the selected between-group Hb difference remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "A justified important between-group difference for the selected B12-deficiency anemia, day-90 Hb and active comparator"
    },
    {
      "item_id": "N18",
      "question_type": "Superiority, equivalence and NI",
      "question": "Was the authors' interpretation of similarity converted into verified equivalence?",
      "needed": "Original authors' interpretation, superiority/equivalence/NI design and prespecified margins/analysis requirements",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid establishing equivalence, NI or an effect of 0 from nonsignificance or similar numerical values.",
      "application_exception": "The selected question concerns superiority; do not invent an NI margin or perform a new NI reassessment.",
      "criterion": "Preserve the authors' interpretation together with the empty formal_Hb_NI_margin and the several establishment flags set to false.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If an NI/equivalence question is separately assigned, review its prespecified margin, analysis and precision against the relevant requirements.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The authors interpreted the routes as similarly effective, but prespecified equivalence/NI margins and requirements remain unverified. formal_Hb_NI_margin is empty, and establishment of superiority, equivalence, NI and no effect was retained as false.",
      "condition_status": "Partly verified",
      "status_reason": "The original interpretation exists, but the formal evidence for equivalence/NI and requirements for establishing superiority have not been verified.",
      "missingness": "The original interpretation exists, but the formal evidence for equivalence/NI and requirements for establishing superiority have not been verified.",
      "uncertainty": "The original interpretation exists, but the formal evidence for equivalence/NI and requirements for establishing superiority have not been verified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original authors' interpretation, superiority/equivalence/NI design and prespecified margins/analysis requirements"
    },
    {
      "item_id": "N19",
      "question_type": "Allocation and completer denominators",
      "question": "Which denominators do 70/10/26/34 each represent?",
      "needed": "70 enrolled, 10 lost to follow-up after day10, oral 26/IM34 analyzed, original allocation by arm and numbers measured at each time point",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid using completer counts as original allocation counts or counts for all time points/safety analyses.",
      "application_exception": "Preserve the historical denominators; do not calculate and fill in dropout rates, participant totals or original denominators by arm in this review.",
      "criterion": "Distinguish enrollment, attrition and completer analysis from unverified original allocation by arm.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Link the original flow diagram, arm-specific visit/analysis denominators and handling of missing data to the outcome of interest.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "After 70 participants were enrolled, 10 lost to follow-up after day10 were excluded, and oral 26/IM 34 were analyzed. Original allocation denominators by arm remain unverified. Completer counts were not used as initial allocation counts, and the 10/70 dropout rate was not newly calculated.",
      "condition_status": "Partly verified",
      "status_reason": "Total enrollment/losses and completer counts are available, but original allocation by arm and measurements/analyses at each time point remain unverified.",
      "missingness": "Total enrollment/losses and completer counts are available, but original allocation by arm and measurements/analyses at each time point remain unverified.",
      "uncertainty": "Total enrollment/losses and completer counts are available, but original allocation by arm and measurements/analyses at each time point remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "70 enrolled, 10 lost to follow-up after day10, oral 26/IM34 analyzed, original allocation by arm and numbers measured at each time point"
    },
    {
      "item_id": "N20",
      "question_type": "Missing data and analysis population",
      "question": "Can the effect of assignment/ITT be verified from completer results?",
      "needed": "Reasons for losses/distribution by arm, relationship to outcomes, ITT/imputation, sensitivity/PP definitions and estimand",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid calling completer analysis ITT or an effect of full adherence.",
      "application_exception": "Do not conclude that a small sample/missing data invalidate the results or imply a specific direction of bias.",
      "criterion": "Show the limitations on interpreting results arising from the exclusion of 10 participants and unverified ITT/imputation.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Obtain arm-specific losses/original outcomes, the planned analysis and sensitivity analyses for missing data.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The current result is a 90-day completer analysis. Arm-specific reasons/distribution for the exclusion of 10 participants and ITT, imputation and sensitivity analyses have not been verified. Completer analysis was not automatically designated an effect of assignment or PP.",
      "condition_status": "Unverified",
      "status_reason": "Detailed evidence on the relevance of missing data, the effect of assignment and the analysis population/handling remains unverified.",
      "missingness": "Detailed evidence on the relevance of missing data, the effect of assignment and the analysis population/handling remains unverified.",
      "uncertainty": "Detailed evidence on the relevance of missing data, the effect of assignment and the analysis population/handling remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Reasons for losses/distribution by arm, relationship to outcomes, ITT/imputation, sensitivity/PP definitions and estimand"
    },
    {
      "item_id": "N21",
      "question_type": "Design and allocation",
      "question": "Have both block randomization and implementation of concealment been verified?",
      "needed": "Single-center parallel active-control design, block allocation/concealment implementation, baseline balance and original Methods",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid claiming that allocation/confounding issues are resolved by the randomized label alone.",
      "application_exception": "Do not convert unreported concealment into confirmed absence of concealment or an official RoB result.",
      "criterion": "Distinguish the reported randomized open-label design from unverified actual concealment.",
      "basis": "M08 §8.1–8.2.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare original allocation implementation and baseline balance with the Hb outcome of interest.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "S01 is a single-center prospective randomized open-label active-control trial and reports block randomization. Implementation of allocation concealment is not reported. No official RoB/GRADE assessment was performed in this review, and concealment failure was not established.",
      "condition_status": "Partly verified",
      "status_reason": "Design/allocation is reported, but verification of actual concealment, implementation and baseline comparisons remains incomplete.",
      "missingness": "Design/allocation is reported, but verification of actual concealment, implementation and baseline comparisons remains incomplete.",
      "uncertainty": "Design/allocation is reported, but verification of actual concealment, implementation and baseline comparisons remains incomplete.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Single-center parallel active-control design, block allocation/concealment implementation, baseline balance and original Methods"
    },
    {
      "item_id": "N22",
      "question_type": "Open-label regimens and measurement",
      "question": "Were the limitations of open-label routes and the objectivity of Hb reviewed separately?",
      "needed": "Patient/clinician/assessor blinding, administration differences, Hb measurement and changes in concomitant treatment",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid dismissing the open-label design because Hb is objective, or automatically judging the entire trial a failure.",
      "application_exception": "Endoscopy blinding does not demonstrate assessor blinding for the Hb outcome.",
      "criterion": "Link the actual oral fruit juice and nurse-administered IM to objective Hb and unverified assessors.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare route-specific care, changes in concomitant treatment and implementation of Hb assessment against the original records.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "In the open-label route comparison, oral administration involved fruit juice and IM was nurse-administered. Hb is an objective test, but analyst blinding/concomitant treatment remain unverified. Endoscopy blinding was not borrowed, and the trial was not automatically classified as failed or unbiased.",
      "condition_status": "Partly verified",
      "status_reason": "The actual open-label/assessment context is retained, but implementation details concerning changes and measurement remain unverified.",
      "missingness": "The actual open-label/assessment context is retained, but implementation details concerning changes and measurement remain unverified.",
      "uncertainty": "The actual open-label/assessment context is retained, but implementation details concerning changes and measurement remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Patient/clinician/assessor blinding, administration differences, Hb measurement and changes in concomitant treatment"
    },
    {
      "item_id": "N23",
      "question_type": "Registration, protocol and SAP",
      "question": "Were S01's prespecified plan and actual results compared?",
      "needed": "S01 registration, protocol, SAP, primary time point/analysis, multiplicity and amendment history",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting an unavailable plan into nonregistration or absence/confirmation of selective reporting.",
      "application_exception": "Do not link other NCT/OB12 plans as S01 registration.",
      "criterion": "Distinguish unverified prespecified plans from actual article reporting and differences in the lists.",
      "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "After verifying identity, compare S01's actual registration/plan/history with its Hb reporting.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "S01 preregistration, protocol/SAP and the unique primary-visit hierarchy remain unverified. The S23–S26 shells or the OB12 protocol were not used as the S01 plan. Failure to obtain material does not establish nonregistration or selective reporting.",
      "condition_status": "Unverified",
      "status_reason": "Material for comparing prespecified plans, multiplicity and selection/changes for the Hb outcome of interest remains unverified.",
      "missingness": "Material for comparing prespecified plans, multiplicity and selection/changes for the Hb outcome of interest remains unverified.",
      "uncertainty": "Material for comparing prespecified plans, multiplicity and selection/changes for the Hb outcome of interest remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S01 registration, protocol, SAP, primary time point/analysis, multiplicity and amendment history"
    },
    {
      "item_id": "N24",
      "question_type": "Reports and trial families",
      "question": "Are 28 original articles, index records and reviews being counted as 28 replications?",
      "needed": "The same DOI/PMID for S01/S02, OB12 original article/protocol/supplementary leads, report types and family links",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid double-counting bibliographic records, indexes, reviews and registry access attempts as independent trials.",
      "application_exception": "Do not calculate new unique trial/participant totals; leave unconfirmed family identities unconfirmed.",
      "criterion": "Explain the same S01 family and different report roles using the exact retained bibliographic records.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Verify each report's family identity by comparing original registration, institutions/recruitment periods and participant overlap.",
      "current_reports": [
        "S01",
        "S02",
        "S04",
        "S05",
        "S27"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "S01/S02 belong to TF-BOL2003 with the same DOI10.1016/S0149-2918(03)90096-8 and PMID14749150. S04/S05 are the OB12 original article/protocol; S27 is a supplementary lead. The 28 bibliographic records include reviews, safety/labels and registry attempts, so they were not counted as 28 trials.",
      "condition_status": "Met",
      "status_reason": "Verification that report overlap/roles are distinguished; unique independent trial and participant counts across all 28 reports were not newly established.",
      "missingness": "Verification that report overlap/roles are distinguished; unique independent trial and participant counts across all 28 reports were not newly established.",
      "uncertainty": "Verification that report overlap/roles are distinguished; unique independent trial and participant counts across all 28 reports were not newly established.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "The same DOI/PMID for S01/S02, OB12 original article/protocol/supplementary leads, report types and family links"
    },
    {
      "item_id": "N25",
      "question_type": "Replication of the same question",
      "question": "Are other B12 studies being called replications of the same day-90 Hb result?",
      "needed": "Unique direct comparisons matching the population, product, route, active comparator and day-90 Hb/denominators",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid creating independent replication from similar results involving other forms, populations or endpoints.",
      "application_exception": "Preserve the historical R1 code, but do not use it as certification of strong confirmatory evidence or as a new independent trial count.",
      "criterion": "Separate the single direct family within the current narrow boundary from eligibility limitations of other studies.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If a new directly eligible comparison is authorized/obtained, compare family-specific criteria and opposing results together.",
      "current_reports": [
        "S01",
        "S04",
        "S06",
        "S13"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The retained decisive direct family is TF-BOL2003 alone; R1 is the internal code for that narrow boundary. Replication of the exact same claim could not be verified. Differences in other populations/forms/endpoints were not converted into R0, and no new replication count was calculated.",
      "condition_status": "Unverified",
      "status_reason": "Independent replication of this actual regimen/population/endpoint at 90 days remains unverified within the current retained scope.",
      "missingness": "Independent replication of this actual regimen/population/endpoint at 90 days remains unverified within the current retained scope.",
      "uncertainty": "Independent replication of this actual regimen/population/endpoint at 90 days remains unverified within the current retained scope.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Unique direct comparisons matching the population, product, route, active comparator and day-90 Hb/denominators"
    },
    {
      "item_id": "N26",
      "question_type": "Favorable opposing evidence",
      "question": "Are Gupta2025's favorable Hb results and the reason for exclusion both present?",
      "needed": "S06 Hb results in anemic women, confirmed B12-deficiency anemia stratum/background IFA, product/denominators/duration",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid transferring only favorable results to the target population or erasing results by retaining only the fact of exclusion.",
      "application_exception": "Do not newly read the S06 PDF or invent a confirmed stratum/quantitative results to fill gaps in this review.",
      "criterion": "Preserve the lead to favorable Hb results together with exclusion because a confirmed B12-deficiency anemia stratum is unverified.",
      "basis": "M03 §3.2.1; detailed population criteria are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Compare original S06 eligibility, strata/product/background treatment and exact Hb results as a separate eligibility question.",
      "current_reports": [
        "S06"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Gupta2025's favorable Hb results are preserved, but were not combined with this claim because there was no confirmed B12-deficiency anemia stratum. Retain the historical selected S06 PDF pages and locations: p721 eligibility/common IFA, p724 Hb and p726 safety/funding/registration.",
      "condition_status": "Met",
      "status_reason": "Verification of preservation of positive evidence and reasons for exclusion; not new verification of S06 numerical results or full text in this review.",
      "missingness": "Verification of preservation of positive evidence and reasons for exclusion; not new verification of S06 numerical results or full text in this review.",
      "uncertainty": "Verification of preservation of positive evidence and reasons for exclusion; not new verification of S06 numerical results or full text in this review.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S06 Hb results in anemic women, confirmed B12-deficiency anemia stratum/background IFA, product/denominators/duration"
    },
    {
      "item_id": "N27",
      "question_type": "Unfavorable opposing evidence",
      "question": "Are Tandon2022's results unfavorable to oral treatment and the reason for pediatric exclusion present?",
      "needed": "S13 pediatric nutritional megaloblastic anemia, direction of Hb findings in the original abstract and difference from the adult boundary",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid erasing unfavorable results or combining them with effects in adults.",
      "application_exception": "Pediatric exclusion is not deletion/invalidation of unfavorable results or a judgment of harm in adults.",
      "criterion": "Retain both the unfavorable direction of Hb findings in the pediatric trial and its exclusion from application.",
      "basis": "M03 §3.2.1; detailed population criteria are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Obtain the population/regimen/time points, denominators and results within their original scope, and link them to a separate pediatric question.",
      "current_reports": [
        "S13"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Tandon2022's Hb results unfavorable to oral treatment are preserved, but were not combined with this adult claim because it was a pediatric trial. Historical access to only lines40–44 of the original S13 abstract was not converted into current full-text verification.",
      "condition_status": "Met",
      "status_reason": "Verification of preservation of unfavorable evidence and the population-based reason for exclusion. Do not combine it as direct contradiction or replication in adults.",
      "missingness": "Verification of preservation of unfavorable evidence and the population-based reason for exclusion. Do not combine it as direct contradiction or replication in adults.",
      "uncertainty": "Verification of preservation of unfavorable evidence and the population-based reason for exclusion. Do not combine it as direct contradiction or replication in adults.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S13 pediatric nutritional megaloblastic anemia, direction of Hb findings in the original abstract and difference from the adult boundary"
    },
    {
      "item_id": "N28",
      "question_type": "Adjacent endpoints and routes",
      "question": "Are serum B12, Hct and other routes substituting for the selected Hb outcome?",
      "needed": "Roles of reports on Kuzminski Hct, OB12 serum normalization, metabolism/preferences/RYGB and other forms/intranasal/IV administration",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid satisfying endpoint and product/route eligibility merely through similarity of blood-measure or molecular names.",
      "application_exception": "Retain the original bibliography/access record, but do not use it as a basis for creating unreported Hb values.",
      "criterion": "Link endpoint/population/route limitations of each adjacent study to the original locations.",
      "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.4; internally defined boundaries for extending the claim",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "After actually obtaining each original Methods/table and population-specific Hb results, separately review whether it addresses the same question.",
      "current_reports": [
        "S03",
        "S04",
        "S05",
        "S07",
        "S08",
        "S12",
        "S14"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Hct in S03, serum B12 normalization NI in OB12 S04/S05, biomarkers/preferences in S07, RYGB in S08, metformin/Sucrosomial serum B12 in S12 and 3 non-oral routes in S14 differ from the selected day-90 Hb outcome. The relevant bibliography/access levels were preserved, and no new Hb results were created.",
      "condition_status": "Met",
      "status_reason": "Verification explaining the applicability boundaries of the question/materials; not an efficacy reassessment of adjacent studies.",
      "missingness": "Verification explaining the applicability boundaries of the question/materials; not an efficacy reassessment of adjacent studies.",
      "uncertainty": "Verification explaining the applicability boundaries of the question/materials; not an efficacy reassessment of adjacent studies.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Roles of reports on Kuzminski Hct, OB12 serum normalization, metabolism/preferences/RYGB and other forms/intranasal/IV administration"
    },
    {
      "item_id": "N29",
      "question_type": "Reviews and unaccessed leads",
      "question": "Were review summaries/registry shells used as original trial results?",
      "needed": "Material types and reading scope for unaccessed S09–S11, reviews/evidence tables S15–S19 and registry/supplementary leads S23–S28",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid calling review bibliographies and shells/pointers actual plans, full texts or independent replications.",
      "application_exception": "Do not convert unverified information into nonregistration, absence of studies or absence of corrections.",
      "criterion": "Distinguish each material's historical access, nonreading, unverified results and direct/indirect role.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "In an authorized update, compare identities, content and families of original reports, official registry records and supplements.",
      "current_reports": [
        "S09",
        "S10",
        "S11",
        "S15",
        "S17",
        "S19",
        "S23",
        "S24",
        "S25",
        "S26",
        "S27",
        "S28"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Preserve the historical scope: S09 abstract/full text inaccessible, S10 conference bibliography/results inaccessible, S11 indexed excerpt, S15 official summary/full review inaccessible, S17 first PDF page, and S19 excerpt favoring injections for Hb/underlying trial unverified. S23–S26 are JS shells, S27 an unopened supplementary lead, and S28 an article's CTRI mention without an obtained official record.",
      "condition_status": "Partly verified",
      "status_reason": "Leads/review roles exist, but comparison of unaccessed original results, registry plans/history and underlying families remains unverified.",
      "missingness": "Leads/review roles exist, but comparison of unaccessed original results, registry plans/history and underlying families remains unverified.",
      "uncertainty": "Leads/review roles exist, but comparison of unaccessed original results, registry plans/history and underlying families remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Material types and reading scope for unaccessed S09–S11, reviews/evidence tables S15–S19 and registry/supplementary leads S23–S28"
    },
    {
      "item_id": "N30",
      "question_type": "Funding and product supply",
      "question": "Does I1 verify actual mixed funding or independence?",
      "needed": "S01 research funding, product supply, author disclosures/institutions and original Funding/COI",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting a rule-based value for unverified funding into actual mixed funding, independence or absence of COI.",
      "application_exception": "Do not transfer funding or product-supply information from other OB12/review materials to S01, or exclude automatically on the basis of COI.",
      "criterion": "Separate unverified funding/product supply from the meaning of the historical I1 fallback.",
      "basis": "Chamgap's own criteria for independence and attribution. The official methods sections used in this pilot do not guarantee every detail of this item",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check original S01 funding/supply, author disclosures, relevant institutions and family information.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "S01 funding sources and product supply remain unverified. I1 is an internal rule-based value for unverified funding, not proof of mixed funding. Author employment/patents, absence of disclosed COI and independent funding were not inferred.",
      "condition_status": "Unverified",
      "status_reason": "Original disclosures of independence/conflicts of interest and product-supply materials remain unverified.",
      "missingness": "Original disclosures of independence/conflicts of interest and product-supply materials remain unverified.",
      "uncertainty": "Original disclosures of independence/conflicts of interest and product-supply materials remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S01 research funding, product supply, author disclosures/institutions and original Funding/COI"
    },
    {
      "item_id": "N31",
      "question_type": "Historical assessment and methods",
      "question": "Are C, 46, E~ and the empty precision value being read as a new assessment or an MCID?",
      "needed": "Boundaries of the original grade/score/Caution, axes, document quality A, self-review and method implementation",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the original score/codes into checklist-based efficacy probabilities, fulfillment rates or official GRADE certification.",
      "application_exception": "Do not calculate scores, grades, dispersion or new sufficiency numbers, or judge efficacy by the number of criteria.",
      "criterion": "Distinguish historical C46 and B/S/R1/I1/E~/B2/empty precision from document quality and review scope.",
      "basis": "M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If an individual correction is authorized, review it as a separate event preserving the complete original assessment, before/after values and reasons.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Leave historical efficacy C, 46, Caution and B/S/R1/I1/E~/B2/empty precision unchanged. E~ is not proof of failure to meet an MCID or statistical positivity; empty precision does not mean no CI. Document quality A and single-assistant self-review are not independent clinical/GRADE certification.",
      "condition_status": "Met",
      "status_reason": "Verification of preservation of historical values and methodological interpretation boundaries; not a new efficacy, safety or grade assessment.",
      "missingness": "Verification of preservation of historical values and methodological interpretation boundaries; not a new efficacy, safety or grade assessment.",
      "uncertainty": "Verification of preservation of historical values and methodological interpretation boundaries; not a new efficacy, safety or grade assessment.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Boundaries of the original grade/score/Caution, axes, document quality A, self-review and method implementation"
    },
    {
      "item_id": "N32",
      "question_type": "Current and historical reading",
      "question": "Is this review's summary reading distinguished from historical full-text transcription access?",
      "needed": "Exact pointers in the currently stored manuscript, 28 bibliographic records/locations and historical material types/access levels/dates",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid retroactively treating historical reading of transcriptions, PDFs and official documents as actual original-source reading in this review.",
      "application_exception": "Do not newly label all currently unattempted external materials as inaccessible.",
      "criterion": "Keep the actual reading of retained summaries in this review and the original historical access on 2026-09-16 as separate materials/links.",
      "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If original-material acquisition/actual reading is authorized, separately record the edition, sections read and file SHA for each material type.",
      "current_reports": [
        "S01",
        "S02",
        "S06",
        "S17",
        "S20",
        "S21",
        "S22"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Reading in this review covers the current 3113 stored summary's 17 KO fields, structure/1 evidence entry and 28 bibliographic/historical access records. The historical 2026-09-16 scope, including the S01 repository full-text transcription, selected S06 PDF pages, the first S17 PDF page and official safety documents, was not converted into current external reading. Summary links connect to actual values/pointers/stored-summary SHA.",
      "condition_status": "Met",
      "status_reason": "Verification distinguishing current from historical reading and summaries from original full texts. Not verification of current external original bytes/full texts.",
      "missingness": "Verification distinguishing current from historical reading and summaries from original full texts. Not verification of current external original bytes/full texts.",
      "uncertainty": "Verification distinguishing current from historical reading and summaries from original full texts. Not verification of current external original bytes/full texts.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Exact pointers in the currently stored manuscript, 28 bibliographic records/locations and historical material types/access levels/dates"
    },
    {
      "item_id": "N33",
      "question_type": "Original PDF/transcription comparison",
      "question": "Has a current visual comparison with the publisher PDF been performed?",
      "needed": "Original publisher PDF, repository transcription, tables/units/footnotes and a visual-comparison event",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting a repository full-text transcription into direct verification of the publisher PDF.",
      "application_exception": "The file preserved in this review is a limited stored summary, not the original bytes of the full text.",
      "criterion": "Retain historical S01 transcription access separately from the unverified visual comparison with the publisher PDF.",
      "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "After authorized/lawful acquisition of the original PDF, compare actual tables, footnotes and text against the transcription and record the edition/hash.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Historical S01 access was to a repository full-text transcription. Visual comparison with the publisher PDF remains unresolved; the original PDF, old ZIP, calculation log and transcription were not newly opened in this review. The stored manuscript SHA was not described as the original article PDF SHA.",
      "condition_status": "Unverified",
      "status_reason": "A current visual comparison of the original publisher PDF with the transcription, numerical values and hierarchy remains unverified.",
      "missingness": "A current visual comparison of the original publisher PDF with the transcription, numerical values and hierarchy remains unverified.",
      "uncertainty": "A current visual comparison of the original publisher PDF with the transcription, numerical values and hierarchy remains unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original publisher PDF, repository transcription, tables/units/footnotes and a visual-comparison event"
    },
    {
      "item_id": "N34",
      "question_type": "Search, registration and publication status",
      "question": "Are gaps in the current retained scope being described as absence of current studies?",
      "needed": "Evidence cutoff 2026-09-16, original search/access summaries, actual reading in this review and scope regarding unpublished material/corrections/retractions",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid overstating conversion of stored materials as a current exhaustive search on 2026-10-05.",
      "application_exception": "The existence of an original search-log path does not mean that the log/DB export was read in this review.",
      "criterion": "Specify the historical actual-search summary, 0 new searches in this review and the unverified scope regarding DBs, registration and corrections.",
      "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "In a separately authorized update, record actual search expressions, scope, failures and original responses for searches/registration/corrections as a new event.",
      "current_reports": [
        "S23",
        "S24",
        "S25",
        "S26",
        "S28"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The evidence cutoff is 2026-09-16, and the actual review date recorded here is 2026-10-05. Original audit/search_log and access_log paths/summaries and the absence of subscription Embase/Scopus searches or complete exports are historical. New clinical searches/registry/correction queries for 3113 in this review total 0; gaps were not converted into absence of studies.",
      "condition_status": "Met",
      "status_reason": "Verification of the criterion distinguishing the cutoff date and review scope; not a current exhaustive check of existence, corrections or retractions.",
      "missingness": "Verification of the criterion distinguishing the cutoff date and review scope; not a current exhaustive check of existence, corrections or retractions.",
      "uncertainty": "Verification of the criterion distinguishing the cutoff date and review scope; not a current exhaustive check of existence, corrections or retractions.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Evidence cutoff 2026-09-16, original search/access summaries, actual reading in this review and scope regarding unpublished material/corrections/retractions"
    },
    {
      "item_id": "N35",
      "question_type": "Harm definitions and collection",
      "question": "Does no reported treatment-related adverse reaction mean total AE0?",
      "needed": "S01 treatment-related AE definition, collection method, all AEs/SAEs, discontinuations, severity and original denominators",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the original sentence into complete event accounting or absence of all harms.",
      "application_exception": "Do not delete efficacy results because harms were not reported or assign a new safety grade.",
      "criterion": "Display no reported treatment-related events separately from unverified total events, collection and discontinuations.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check the original Tolerability section, collection/adverse-event tables and discontinuation/loss records.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The original statement is a 90-day record for oral 26/IM34 that no treatment-related adverse reactions were reported. Separate accounting and collection methods for all AEs, SAEs and AE-related discontinuations remain unverified; this was not converted into all AE0.",
      "condition_status": "Partly verified",
      "status_reason": "A treatment-related narrative is available, but total-event definitions, systematic collection, severity and discontinuation accounting remain unverified.",
      "missingness": "A treatment-related narrative is available, but total-event definitions, systematic collection, severity and discontinuation accounting remain unverified.",
      "uncertainty": "A treatment-related narrative is available, but total-event definitions, systematic collection, severity and discontinuation accounting remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S01 treatment-related AE definition, collection method, all AEs/SAEs, discontinuations, severity and original denominators"
    },
    {
      "item_id": "N36",
      "question_type": "Safety denominators and losses",
      "question": "Does safety coverage include the 10 participants outside the 26/34 completers?",
      "needed": "Total exposure/safety denominators, numbers of affected people/events, 90-day/early follow-up and safety of the 10 lost participants",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid using a related-AE narrative limited to completers as an incidence estimate for all enrolled participants.",
      "application_exception": "Preserve the original denominators; do not calculate incidence, an upper bound for rare harms or AEs among lost participants in this review.",
      "criterion": "Show the denominators/duration of the completer narrative and the safety gap for those lost to follow-up.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Link arm-specific exposure/safety analysis counts, reasons for losses/events and follow-up duration to the original records.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Link the treatment-related AE narrative to the oral 26/IM 34 analyzed at 90 days. Safety of the 10 participants lost after day10 remains unverified. It was not stated that all events were collected for all 70 enrolled participants or that event incidence was 0.",
      "condition_status": "Partly verified",
      "status_reason": "Analysis duration and completer counts are available, but the total safety denominator, events among lost participants, exposure time and incidence remain unverified.",
      "missingness": "Analysis duration and completer counts are available, but the total safety denominator, events among lost participants, exposure time and incidence remain unverified.",
      "uncertainty": "Analysis duration and completer counts are available, but the total safety denominator, events among lost participants, exposure time and incidence remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Total exposure/safety denominators, numbers of affected people/events, 90-day/early follow-up and safety of the 10 lost participants"
    },
    {
      "item_id": "N37",
      "question_type": "Harms: timing, comparison and alternatives",
      "question": "Does a no-event narrative verify comparative safety or causal safety of oral treatment?",
      "needed": "Arm-specific events; timing of exposure, onset, discontinuation and recovery; IM comparator; concomitant treatment; baseline/loss-related alternative explanations",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid promoting reporting/nonreporting after exposure into comparative risk or causal safety.",
      "application_exception": "Do not infer a risk difference, dechallenge/rechallenge or absence of alternative explanations solely from no related AEs being reported in both arms.",
      "criterion": "Distinguish the 90-day active-comparator context from unverified event timing, total accounting and alternative explanations.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.2 questions about harms by study design; details of temporal relationships are internally designed; M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check material that permits comparison of original arm-specific events/timing with concomitant treatment, baseline risks and missing data.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "There is a narrative that no related AEs were reported in both arms, but detailed information on event onset/recovery, re-exposure, overall comparative risk, concomitant treatment and safety among lost participants remains unverified. Untreated background incidence and causal safety of oral treatment were not inferred.",
      "condition_status": "Unverified",
      "status_reason": "Events/timing, alternative explanations and denominators for actual comparative harms remain unverified.",
      "missingness": "Events/timing, alternative explanations and denominators for actual comparative harms remain unverified.",
      "uncertainty": "Events/timing, alternative explanations and denominators for actual comparative harms remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Arm-specific events; timing of exposure, onset, discontinuation and recovery; IM comparator; concomitant treatment; baseline/loss-related alternative explanations"
    },
    {
      "item_id": "N38",
      "question_type": "Official safety materials and independent events",
      "question": "Are official notices/labels being counted as independent clinical replications of harms?",
      "needed": "Material types/molecules, underlying events, denominators and families for S20 ODS, S21 cobalt notice and S22 injection label",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the authority of official documents or repeated citations into new independent events/incidence.",
      "application_exception": "Distinguish the chemical forms/routes in each notice; do not label this review as a new check of current full texts or underlying event data.",
      "criterion": "Keep historical bibliographies/boundaries of safety documents separate from clinical-trial denominators/events.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2; adaptations for harm materials are internally designed; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "In an authorized update, compare notice versions, original events/denominators and relationships among repeated citations.",
      "current_reports": [
        "S20",
        "S21",
        "S22"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "S20 official explanatory material, S21 cyanocobalamin/hydroxocobalamin cobalt notice and S22 cyanocobalamin injection label are historical materials. These 3 documents were not counted as 3 independent harm trials/events, and current underlying material was not newly verified in this review.",
      "condition_status": "Partly verified",
      "status_reason": "The types/boundaries of official materials are retained, but independent events, denominators/causes and comparison with current editions remain unverified.",
      "missingness": "The types/boundaries of official materials are retained, but independent events, denominators/causes and comparison with current editions remain unverified.",
      "uncertainty": "The types/boundaries of official materials are retained, but independent events, denominators/causes and comparison with current editions remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Material types/molecules, underlying events, denominators and families for S20 ODS, S21 cobalt notice and S22 injection label"
    },
    {
      "item_id": "N39",
      "question_type": "UL and safety interpretation",
      "question": "Does an unset UL guarantee unlimited safety?",
      "needed": "S20 B12 UL explanation and reasons for no established UL; boundaries of the selected regimen's duration/population and actual events",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid converting the absence of an established upper safety limit into safety at every dose or for every person.",
      "application_exception": "The study schedule/Caution is not an instruction for personal dosing, injections, transfusions or medication changes.",
      "criterion": "Specify the distinction between no established UL and established safety, and the historical Caution.",
      "basis": "M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If asking about safety by dose, duration or vulnerable population, review the relevant direct evidence under separate criteria.",
      "current_reports": [
        "S20"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "In retained S20, no established B12 UL does not guarantee unlimited safety. The original Caution safety label was retained; the study dose/schedule was not made into instructions for personal dosing, injection choice, transfusion or medication changes.",
      "condition_status": "Met",
      "status_reason": "Verification of preservation of the scope of safety interpretation; not absence of harm or certification of personal safety.",
      "missingness": "Verification of preservation of the scope of safety interpretation; not absence of harm or certification of personal safety.",
      "uncertainty": "Verification of preservation of the scope of safety interpretation; not absence of harm or certification of personal safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S20 B12 UL explanation and reasons for no established UL; boundaries of the selected regimen's duration/population and actual events"
    },
    {
      "item_id": "N40",
      "question_type": "Cobalt and injection warnings",
      "question": "Were the label's chemical form/route transferred into oral-treatment incidence?",
      "needed": "S21 scope of cobalt sensitivity for cyano/hydroxo; S22 injection context for Leber/early hypokalemia",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid transferring a specific injection warning into observed incidence for all oral treatments/chemical forms.",
      "application_exception": "The existence of a warning and actual S01 events, causality and incidence are different information.",
      "criterion": "Link original warnings for each chemical form/route and special circumstance to their own scope.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "Check original label/notice editions and underlying events separately from direct oral-treatment/special-population evidence.",
      "current_reports": [
        "S21",
        "S22"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Link cobalt sensitivity to the verified cyano/hydroxo notice. Leber and early hypokalemia during intensive treatment of severe megaloblastic anemia fall within the cyanocobalamin injection-label scope. These were not converted into incidence for oral treatment/other chemical forms or observed S01 events.",
      "condition_status": "Partly verified",
      "status_reason": "Original warnings/scope are retained, but direct incidence for the selected oral regimen and harms in special populations remain unverified.",
      "missingness": "Original warnings/scope are retained, but direct incidence for the selected oral regimen and harms in special populations remain unverified.",
      "uncertainty": "Original warnings/scope are retained, but direct incidence for the selected oral regimen and harms in special populations remain unverified.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "S21 scope of cobalt sensitivity for cyano/hydroxo; S22 injection context for Leber/early hypokalemia"
    },
    {
      "item_id": "N41",
      "question_type": "Long-term harms and vulnerable populations",
      "question": "Do short-term adult data answer questions about rare harms or long-term/special-population safety?",
      "needed": "Long-term/rare events, exposure/baseline risk in hepatic or renal disease, pregnancy/lactation and children, denominators and suitable designs",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid extending a population limited to 90 days into safety for all special populations/durations.",
      "application_exception": "Preserve the selected efficacy evidence; do not require every rare-harm study as a fulfillment condition for that Hb result.",
      "criterion": "Show the original 90-day/nonpregnant, nonlactating adult scope and unverified safety beyond it.",
      "basis": "M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If a safety extension is requested, separately review observational/comparative data appropriate to the population, duration and events.",
      "current_reports": [
        "S01",
        "S20",
        "S21",
        "S22"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Do not establish long-term safety or safety in hepatic or renal disease, pregnancy/lactation or children from this trial. The 90-day adult completer data do not prove safety regarding rare events or beyond follow-up; the original Caution was retained.",
      "condition_status": "Unverified",
      "status_reason": "Direct evidence on harms/vulnerable populations outside the selected 90-day scope remains unverified within the current retained materials.",
      "missingness": "Direct evidence on harms/vulnerable populations outside the selected 90-day scope remains unverified within the current retained materials.",
      "uncertainty": "Direct evidence on harms/vulnerable populations outside the selected 90-day scope remains unverified within the current retained materials.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Long-term/rare events, exposure/baseline risk in hepatic or renal disease, pregnancy/lactation and children, denominators and suitable designs"
    },
    {
      "item_id": "N42",
      "question_type": "Direct dose optimization",
      "question": "Must a same-schedule comparison also answer the optimal-dose question?",
      "needed": "If an optimal-dose question is added: direct dose/active-amount comparisons, actual exposure and Hb/harm estimates",
      "role": "Extension boundary; required for an optimal-dose claim",
      "role_reason": "Needed to avoid extending a comparison of two regimens with the same nominal schedule into dose response or optimal dosing.",
      "application_exception": "Do not require trials of multiple doses for the narrow 90-day route/regimen comparison.",
      "criterion": "Explain that the selected question is not an optimal-dose comparison, with the original dose and boundaries.",
      "basis": "M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If optimization is separately requested, design direct dose contrasts and harm assessment in the same population/product.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "This is a 90-day Hb comparison with the same nominal 1000mcg schedule in both arms, not a dose-selection/response question. Optimal-dose evidence was not required to complete this question, and no effective recommended dose was newly created.",
      "condition_status": "Not applicable",
      "status_reason": "Extension to optimal dosing does not apply to the currently fixed question; this is not replacement of gaps in actual exposure, adherence or total dose with NA.",
      "missingness": "Extension to optimal dosing does not apply to the currently fixed question; this is not replacement of gaps in actual exposure, adherence or total dose with NA.",
      "uncertainty": "Extension to optimal dosing does not apply to the currently fixed question; this is not replacement of gaps in actual exposure, adherence or total dose with NA.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "If an optimal-dose question is added: direct dose/active-amount comparisons, actual exposure and Hb/harm estimates"
    },
    {
      "item_id": "N43",
      "question_type": "Long-term maintenance and effects of discontinuation",
      "question": "Were lifelong maintenance/discontinuation effects mixed into the 90-day question?",
      "needed": "If a long-term maintenance/discontinuation question is added: actual follow-up, post-discontinuation Hb and exposure/denominators",
      "role": "Extension boundary; required for maintenance/discontinuation claims",
      "role_reason": "Needed to avoid converting a lifelong monthly plan into lifelong effects or maintenance after discontinuation.",
      "application_exception": "Do not require lifelong follow-up for the selected 90-day comparison.",
      "criterion": "Separate the selected 90-day question from questions about long-term effects or effects of discontinuation.",
      "basis": "M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If a long-term extension is requested, obtain actual exposure/follow-up and arm-specific outcomes, rather than plans.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The selected question is the 90-day Hb comparison; a lifelong monthly plan is not observation. Lifelong effects/maintenance after discontinuation are separate questions and were not required for this selected efficacy question.",
      "condition_status": "Not applicable",
      "status_reason": "A long-term extension is not applicable to the selected 90-day efficacy question. Unverified long-term safety is retained separately.",
      "missingness": "A long-term extension is not applicable to the selected 90-day efficacy question. Unverified long-term safety is retained separately.",
      "uncertainty": "A long-term extension is not applicable to the selected 90-day efficacy question. Unverified long-term safety is retained separately.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "If a long-term maintenance/discontinuation question is added: actual follow-up, post-discontinuation Hb and exposure/denominators"
    },
    {
      "item_id": "N44",
      "question_type": "Extension to clinical events",
      "question": "Is Hb an effect on fatigue, transfusion, death or daily functioning?",
      "needed": "If an event/quality-of-life claim is added: the relevant direct endpoint, time point/denominators and importance",
      "role": "Extension boundary; required for event/quality-of-life claims",
      "role_reason": "Needed to avoid converting a laboratory surrogate into an effect on clinical events or patient functioning.",
      "application_exception": "Do not require an event trial for a question about the Hb value itself.",
      "criterion": "Explain the boundary between laboratory Hb S and separate event/function endpoints.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M03 §3.2.4; internally defined boundaries for extending the claim",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If extension to events is requested, separately obtain between-group data on the direct endpoint of interest.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The selected outcome is the day-90 Hb(g/dL) laboratory surrogate; fatigue, transfusion, death and daily functioning are different questions. Event trials were not required for this Hb report, and Hb improvement was not extended into an effect on events.",
      "condition_status": "Not applicable",
      "status_reason": "Extension to events is not applicable to the current numerical-outcome question. Neither absence nor presence of separate efficacy on events is established.",
      "missingness": "Extension to events is not applicable to the current numerical-outcome question. Neither absence nor presence of separate efficacy on events is established.",
      "uncertainty": "Extension to events is not applicable to the current numerical-outcome question. Neither absence nor presence of separate efficacy on events is established.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "If an event/quality-of-life claim is added: the relevant direct endpoint, time point/denominators and importance"
    },
    {
      "item_id": "N45",
      "question_type": "Extension to other products and routes",
      "question": "Are effects of tablets or other chemical forms/routes being compulsorily combined?",
      "needed": "If a separate product/route claim is added: direct Hb comparison for that product, population and regimen",
      "role": "Extension boundary; required for claims about other products/routes",
      "role_reason": "Needed to avoid extending the actual ampule+fruit juice comparison to all B12 products/routes.",
      "application_exception": "Do not require trials of other products for the selected regimen or erase gaps in original product details with NA.",
      "criterion": "Show the boundary between actual Dodex and extension to methyl/hydroxo/adeno, tablets/sublingual/intranasal/IV administration.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed; M03 §3.2.4; internally defined boundaries for extending the claim",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If a separate regimen question is authorized, first fix the direct Hb criteria for each identity/route.",
      "current_reports": [
        "S01",
        "S14"
      ],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The current assessment concerns oral Dodex ampule+fruit juice versus the same cyano IM. Tablet, other chemical-form, sublingual, intravenous and intranasal results were not compulsorily combined. Gaps in the actual original product's batch/adherence were retained separately.",
      "condition_status": "Not applicable",
      "status_reason": "Extensions outside the selected regimen are not applicable; this does not mean that all products/routes have the same effects.",
      "missingness": "Extensions outside the selected regimen are not applicable; this does not mean that all products/routes have the same effects.",
      "uncertainty": "Extensions outside the selected regimen are not applicable; this does not mean that all products/routes have the same effects.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "If a separate product/route claim is added: direct Hb comparison for that product, population and regimen"
    },
    {
      "item_id": "N46",
      "question_type": "ID and publication metadata",
      "question": "Are original ID/code and deployment expressions being read as the publication status of this review?",
      "needed": "KO needs_id_assignment, null semantic, original automatic codes/assigned, server_deployed/not-deployed expressions and original URLs/dates",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid hiding differences in original expressions or using historical deployment flags to say that this sheet has been publicly published.",
      "application_exception": "Do not silently correct original values or arbitrarily establish authority precedence between general metadata and a specific semantic field.",
      "criterion": "Preserve differing original identity/deployment expressions and separate them from this local unpublished work.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If an identity/deployment correction is separately authorized, record the complete original, authority/decision and before/after values as an event.",
      "current_reports": [],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "The KO summary's ID/URL/semantic-code needs_id_assignment and the empty permanent_semantic_code/status coexist with general permanent/classification/semantic codes marked filled/assigned. initial_current_value_not_deployed, server_writefalse, server_deployedtrue, historical deployed_at and original final_url were also preserved. Public deployments of this local sheet total 0.",
      "condition_status": "Partly verified",
      "status_reason": "Original identity/deployment expressions are preserved, but authority precedence and corrections to actual original publication status were not established within this scope.",
      "missingness": "Original identity/deployment expressions are preserved, but authority precedence and corrections to actual original publication status were not established within this scope.",
      "uncertainty": "Original identity/deployment expressions are preserved, but authority precedence and corrections to actual original publication status were not established within this scope.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "KO needs_id_assignment, null semantic, original automatic codes/assigned, server_deployed/not-deployed expressions and original URLs/dates"
    },
    {
      "item_id": "N47",
      "question_type": "Updates and traceability",
      "question": "Are there update rules that preserve original text, criteria and opposing values?",
      "needed": "Original revision triggers, cutoff/actual review dates, prior freezing of criteria, exact values/pointers/SHA and before/after events/versions",
      "role": "Required (selected day-90 Hb comparison)",
      "role_reason": "Needed to avoid silently overwriting historical values, unfavorable results or criteria versions with new material/corrections.",
      "application_exception": "New research, calculations, reassessments and automatic deployment are not inherited by the current conversion task.",
      "criterion": "Link each row's material, locations read, necessary criteria and reasons for updates with preservation of the complete original.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design",
      "condition_origin": "Development criteria designed with knowledge of the current 3113 retained materials after actually reading them individually. Not blinding, clinical preregistration or independent clinical certification",
      "proposed_research": "If authorized original PDFs, plans, direct trials, funding information or corrections arrive, review them while preserving a separate event, criteria version and before/after values.",
      "current_reports": [],
      "existence": "Stored bibliographic records, structured evidence and historical access records currently exist. This is not a current external check of existence or corrections",
      "acquired_read": "The exact retained summary locations and values were actually read. External or older separate original sources were not read in this review.",
      "observation": "Preserve the original revision_history and update leads concerning PDFs/plans, adjusted/change Hb, arm-specific denominators/rescue treatment, direct trials, funding/corrections and ID. Link the criteria frozen beforehand and observations/pointers, SHA and dates to each row; the original C46/Caution, opposing values and materials were not overwritten.",
      "condition_status": "Met",
      "status_reason": "Verification of the linkage criteria for traceability/update rules; not certification of completion of a new-evidence/correction event or of public publication.",
      "missingness": "Verification of the linkage criteria for traceability/update rules; not certification of completion of a new-evidence/correction event or of public publication.",
      "uncertainty": "Verification of the linkage criteria for traceability/update rules; not certification of completion of a new-evidence/correction event or of public publication.",
      "review_date": "2026-10-05",
      "reading_status": "Original source not read · Stored summary read",
      "additional_material": "Original revision triggers, cutoff/actual review dates, prior freezing of criteria, exact values/pointers/SHA and before/after events/versions"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Bolaman et al. Oral versus intramuscular cobalamin treatment in megaloblastic anemia. Clin Ther. 2003;25:3124–3134.",
      "url": "https://www.academia.edu/22581191/Oral_versus_intramuscular_cobalamin_treatment_in_megaloblastic_anemia_A_single_center_prospective_randomized_open_label_study",
      "report_type": "Direct original article",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "TF-BOL2003",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical direct original article on day-90 Hb in 26/34 completers, accessed as a repository transcription; visual comparison with the original PDF unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S01-M1",
          "url": null,
          "parent_url": "https://www.academia.edu/22581191/Oral_versus_intramuscular_cobalamin_treatment_in_megaloblastic_anemia_A_single_center_prospective_randomized_open_label_study"
        },
        {
          "material_type": "Repository full-text transcription of the original article",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S01-M2",
          "url": "https://www.academia.edu/22581191/Oral_versus_intramuscular_cobalamin_treatment_in_megaloblastic_anemia_A_single_center_prospective_randomized_open_label_study",
          "parent_url": "https://www.academia.edu/22581191/Oral_versus_intramuscular_cobalamin_treatment_in_megaloblastic_anemia_A_single_center_prospective_randomized_open_label_study"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.academia.edu/22581191/Oral_versus_intramuscular_cobalamin_treatment_in_megaloblastic_anemia_A_single_center_prospective_randomized_open_label_study"
        }
      ]
    },
    {
      "report_id": "S02",
      "title": "Bolaman 2003 official PubMed bibliographic record",
      "url": "https://pubmed.ncbi.nlm.nih.gov/14749150/",
      "report_type": "Index of the same original article",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "TF-BOL2003",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Official index search with the same DOI/PMID as S01; historical direct_open_empty",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S02-M1",
          "url": null,
          "parent_url": "https://pubmed.ncbi.nlm.nih.gov/14749150/"
        },
        {
          "material_type": "Official PubMed index/search results",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S02-M2",
          "url": "https://pubmed.ncbi.nlm.nih.gov/14749150/",
          "parent_url": "https://pubmed.ncbi.nlm.nih.gov/14749150/"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/14749150/"
        }
      ]
    },
    {
      "report_id": "S03",
      "title": "Kuzminski et al. Effective treatment of cobalamin deficiency with oral cobalamin. Blood. 1998;92:1191–1198.",
      "url": "https://www.academia.edu/69767265/Effective_treatment_of_cobalamin_deficiency_with_oral_cobalamin",
      "report_type": "Adjacent original article",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical transcription of individual Hct tables/other hematologic biomarkers and additional iron/folate notes; no new Hb values extracted",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S03-M1",
          "url": null,
          "parent_url": "https://www.academia.edu/69767265/Effective_treatment_of_cobalamin_deficiency_with_oral_cobalamin"
        },
        {
          "material_type": "Repository transcription of the original article",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S03-M2",
          "url": "https://www.academia.edu/69767265/Effective_treatment_of_cobalamin_deficiency_with_oral_cobalamin",
          "parent_url": "https://www.academia.edu/69767265/Effective_treatment_of_cobalamin_deficiency_with_oral_cobalamin"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.academia.edu/69767265/Effective_treatment_of_cobalamin_deficiency_with_oral_cobalamin"
        }
      ]
    },
    {
      "report_id": "S04",
      "title": "Sanz-Cuesta et al. OB12. BMJ Open. 2020;10:e033687.",
      "url": "https://www.researchgate.net/publication/343781810_Oral_versus_intramuscular_administration_of_vitamin_B12_for_vitamin_B12_deficiency_in_primary_care_a_pragmatic_randomised_non-inferiority_clinical_trial_OB12",
      "report_type": "Original article on a different endpoint",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "OB12-report linkage",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "OB12 NI for serum B12 normalization is not the same comparison of Hb in a separate anemia stratum",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S04-M1",
          "url": null,
          "parent_url": "https://www.researchgate.net/publication/343781810_Oral_versus_intramuscular_administration_of_vitamin_B12_for_vitamin_B12_deficiency_in_primary_care_a_pragmatic_randomised_non-inferiority_clinical_trial_OB12"
        },
        {
          "material_type": "Repository transcription of the original article",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S04-M2",
          "url": "https://www.researchgate.net/publication/343781810_Oral_versus_intramuscular_administration_of_vitamin_B12_for_vitamin_B12_deficiency_in_primary_care_a_pragmatic_randomised_non-inferiority_clinical_trial_OB12",
          "parent_url": "https://www.researchgate.net/publication/343781810_Oral_versus_intramuscular_administration_of_vitamin_B12_for_vitamin_B12_deficiency_in_primary_care_a_pragmatic_randomised_non-inferiority_clinical_trial_OB12"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.researchgate.net/publication/343781810_Oral_versus_intramuscular_administration_of_vitamin_B12_for_vitamin_B12_deficiency_in_primary_care_a_pragmatic_randomised_non-inferiority_clinical_trial_OB12"
        }
      ]
    },
    {
      "report_id": "S05",
      "title": "Sanz-Cuesta et al. OB12 protocol. BMC Public Health. 2012;12:394.",
      "url": "https://link.springer.com/article/10.1186/1471-2458-12-394",
      "report_type": "Protocol of the same trial",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "OB12-report linkage",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "The OB12 protocol/NI plan is not the S01/day-90 Hb plan",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S05-M1",
          "url": null,
          "parent_url": "https://link.springer.com/article/10.1186/1471-2458-12-394"
        },
        {
          "material_type": "Publisher protocol HTML",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S05-M2",
          "url": "https://link.springer.com/article/10.1186/1471-2458-12-394",
          "parent_url": "https://link.springer.com/article/10.1186/1471-2458-12-394"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://link.springer.com/article/10.1186/1471-2458-12-394"
        }
      ]
    },
    {
      "report_id": "S06",
      "title": "Gupta et al. A prospective, open-label, randomized, comparative study of vitamin B12 administration in anemic women. Int J Reprod Contracept Obstet Gynecol. 2025;14:719–728.",
      "url": "https://www.ijrcog.org/index.php/ijrcog/article/download/15153/9337/63174",
      "report_type": "Favorable result; population excluded",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Gupta2025 favorable Hb results; excluded from the target claim because no confirmed B12-deficiency anemia stratum was available",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S06-M1",
          "url": null,
          "parent_url": "https://www.ijrcog.org/index.php/ijrcog/article/download/15153/9337/63174"
        },
        {
          "material_type": "Publisher article PDF",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S06-M2",
          "url": "https://www.ijrcog.org/index.php/ijrcog/article/download/15153/9337/63174",
          "parent_url": "https://www.ijrcog.org/index.php/ijrcog/article/download/15153/9337/63174"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.ijrcog.org/index.php/ijrcog/article/download/15153/9337/63174"
        }
      ]
    },
    {
      "report_id": "S07",
      "title": "Metaxas et al. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution. Swiss Med Wkly. 2017;147:w14421.",
      "url": "https://smw.ch/index.php/smw/article/download/2291/3463?inline=1",
      "report_type": "Adjacent biomarkers/preferences",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical material on early biomarkers/preferences, baseline Hb and statistical sections; not transferred into the same selected Hb effect",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S07-M1",
          "url": null,
          "parent_url": "https://smw.ch/index.php/smw/article/download/2291/3463?inline=1"
        },
        {
          "material_type": "Publisher HTML",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S07-M2",
          "url": "https://smw.ch/index.php/smw/article/download/2291/3463?inline=1",
          "parent_url": "https://smw.ch/index.php/smw/article/download/2291/3463?inline=1"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://smw.ch/index.php/smw/article/download/2291/3463?inline=1"
        }
      ]
    },
    {
      "report_id": "S08",
      "title": "Schijns et al. Efficacy of oral compared with intramuscular vitamin B-12 after Roux-en-Y gastric bypass. Am J Clin Nutr. 2018;108:6–12.",
      "url": "https://bomss.org/wp-content/uploads/2021/02/Paper-1-Efficacy-B12-im-vs-oral-RCT.pdf",
      "report_type": "Adjacent RYGB population/product",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical PDF on the RYGB population/routes and endpoint list; no inherited identity with the original product/population",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S08-M1",
          "url": null,
          "parent_url": "https://bomss.org/wp-content/uploads/2021/02/Paper-1-Efficacy-B12-im-vs-oral-RCT.pdf"
        },
        {
          "material_type": "Original article PDF hosted by a professional society",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S08-M2",
          "url": "https://bomss.org/wp-content/uploads/2021/02/Paper-1-Efficacy-B12-im-vs-oral-RCT.pdf",
          "parent_url": "https://bomss.org/wp-content/uploads/2021/02/Paper-1-Efficacy-B12-im-vs-oral-RCT.pdf"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://bomss.org/wp-content/uploads/2021/02/Paper-1-Efficacy-B12-im-vs-oral-RCT.pdf"
        }
      ]
    },
    {
      "report_id": "S09",
      "title": "Castelli et al. Comparing efficacy/tolerability of daily oral B12 formulation and intermittent IM B12. Clin Ther. 2011;33:358–371.e2.",
      "url": "https://www.sciencedirect.com/science/article/abs/pii/S0149291811001433",
      "report_type": "Original article abstract/unaccessed lead",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Indexed publisher abstract/evidence-table bibliography; historical full-text inaccessibility, no attempt in this review",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S09-M1",
          "url": null,
          "parent_url": "https://www.sciencedirect.com/science/article/abs/pii/S0149291811001433"
        },
        {
          "material_type": "Search excerpt of the publisher abstract",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S09-M2",
          "url": "https://www.sciencedirect.com/science/article/abs/pii/S0149291811001433",
          "parent_url": "https://www.sciencedirect.com/science/article/abs/pii/S0149291811001433"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.sciencedirect.com/science/article/abs/pii/S0149291811001433"
        }
      ]
    },
    {
      "report_id": "S10",
      "title": "Saraswathy et al. Sa1100 randomized open-label trial of oral vs IM B12. Gastroenterology. 2012;S216.",
      "url": "https://www.researchgate.net/publication/286079745_Sa1100_Randomized_Open_Label_Trial_Comparing_Efficacy_of_Oral_Versus_Intramuscular_Vitamin_B12_Supplementation_for_Treatment_of_Vitamin_B12_Deficiency",
      "report_type": "Conference bibliographic lead",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical access limited to conference-abstract bibliography/DOI; results inaccessible; direct Hb results unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S10-M1",
          "url": null,
          "parent_url": "https://www.researchgate.net/publication/286079745_Sa1100_Randomized_Open_Label_Trial_Comparing_Efficacy_of_Oral_Versus_Intramuscular_Vitamin_B12_Supplementation_for_Treatment_of_Vitamin_B12_Deficiency"
        },
        {
          "material_type": "Conference bibliography/request-full-text page",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S10-M2",
          "url": "https://www.researchgate.net/publication/286079745_Sa1100_Randomized_Open_Label_Trial_Comparing_Efficacy_of_Oral_Versus_Intramuscular_Vitamin_B12_Supplementation_for_Treatment_of_Vitamin_B12_Deficiency",
          "parent_url": "https://www.researchgate.net/publication/286079745_Sa1100_Randomized_Open_Label_Trial_Comparing_Efficacy_of_Oral_Versus_Intramuscular_Vitamin_B12_Supplementation_for_Treatment_of_Vitamin_B12_Deficiency"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.researchgate.net/publication/286079745_Sa1100_Randomized_Open_Label_Trial_Comparing_Efficacy_of_Oral_Versus_Intramuscular_Vitamin_B12_Supplementation_for_Treatment_of_Vitamin_B12_Deficiency"
        }
      ]
    },
    {
      "report_id": "S11",
      "title": "Lacombe et al. Oral vitamin B12 supplementation in pernicious anemia. Am J Clin Nutr. 2024.",
      "url": "https://doi.org/10.1016/j.ajcnut.2024.05.019",
      "report_type": "Indexed excerpt of the original article",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical search excerpt indicating a pernicious-anemia cohort; distinguish publisher inaccessibility from the current absence of an access attempt",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S11-M1",
          "url": null,
          "parent_url": "https://doi.org/10.1016/j.ajcnut.2024.05.019"
        },
        {
          "material_type": "Original-article index excerpt",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S11-M2",
          "url": "https://doi.org/10.1016/j.ajcnut.2024.05.019",
          "parent_url": "https://doi.org/10.1016/j.ajcnut.2024.05.019"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://doi.org/10.1016/j.ajcnut.2024.05.019"
        }
      ]
    },
    {
      "report_id": "S12",
      "title": "Conti et al. Rapid restoration of circulating vitamin B12 using oral Sucrosomial B12 in metformin-associated deficiency. Pharmaceutics. 2026;18:237.",
      "url": "https://www.researchgate.net/publication/400762765_Rapid_Restoration_of_Circulating_Vitamin_B12_Levels_by_Using_Oral_Sucrosomial_Vitamin_B12_in_Metformin-Associated_B12_Deficiency_Results_from_a_Double-Blind_Placebo-Controlled_Randomized_Clinical_Tria",
      "report_type": "Different product/population and endpoint",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Serum B12 data for Sucrosomial B12 versus placebo in metformin-associated deficiency; not the same active-comparator Hb comparison",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S12-M1",
          "url": null,
          "parent_url": "https://www.researchgate.net/publication/400762765_Rapid_Restoration_of_Circulating_Vitamin_B12_Levels_by_Using_Oral_Sucrosomial_Vitamin_B12_in_Metformin-Associated_B12_Deficiency_Results_from_a_Double-Blind_Placebo-Controlled_Randomized_Clinical_Tria"
        },
        {
          "material_type": "Repository transcription of the original article",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S12-M2",
          "url": "https://www.researchgate.net/publication/400762765_Rapid_Restoration_of_Circulating_Vitamin_B12_Levels_by_Using_Oral_Sucrosomial_Vitamin_B12_in_Metformin-Associated_B12_Deficiency_Results_from_a_Double-Blind_Placebo-Controlled_Randomized_Clinical_Tria",
          "parent_url": "https://www.researchgate.net/publication/400762765_Rapid_Restoration_of_Circulating_Vitamin_B12_Levels_by_Using_Oral_Sucrosomial_Vitamin_B12_in_Metformin-Associated_B12_Deficiency_Results_from_a_Double-Blind_Placebo-Controlled_Randomized_Clinical_Tria"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.researchgate.net/publication/400762765_Rapid_Restoration_of_Circulating_Vitamin_B12_Levels_by_Using_Oral_Sucrosomial_Vitamin_B12_in_Metformin-Associated_B12_Deficiency_Results_from_a_Double-Blind_Placebo-Controlled_Randomized_Clinical_Tria"
        }
      ]
    },
    {
      "report_id": "S13",
      "title": "Tandon et al. Parenteral vs oral B12 in children with nutritional macrocytic anemia. Indian Pediatr. 2022;59:683–687.",
      "url": "https://www.researchgate.net/publication/361038123_Parenteral_vs_Oral_Vitamin_B12_in_Children_With_Nutritional_Macrocytic_Anemia_A_Randomized_Controlled_Trial",
      "report_type": "Unfavorable result; children excluded",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Preserve Tandon2022 Hb results unfavorable to oral treatment; excluded from the adult question because the participants were children",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S13-M1",
          "url": null,
          "parent_url": "https://www.researchgate.net/publication/361038123_Parenteral_vs_Oral_Vitamin_B12_in_Children_With_Nutritional_Macrocytic_Anemia_A_Randomized_Controlled_Trial"
        },
        {
          "material_type": "Original article abstract on a repository",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S13-M2",
          "url": "https://www.researchgate.net/publication/361038123_Parenteral_vs_Oral_Vitamin_B12_in_Children_With_Nutritional_Macrocytic_Anemia_A_Randomized_Controlled_Trial",
          "parent_url": "https://www.researchgate.net/publication/361038123_Parenteral_vs_Oral_Vitamin_B12_in_Children_With_Nutritional_Macrocytic_Anemia_A_Randomized_Controlled_Trial"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.researchgate.net/publication/361038123_Parenteral_vs_Oral_Vitamin_B12_in_Children_With_Nutritional_Macrocytic_Anemia_A_Randomized_Controlled_Trial"
        }
      ]
    },
    {
      "report_id": "S14",
      "title": "Singh et al. Comparative efficacy of intranasal, intramuscular and intravenous B12 for hematological recovery in B12-deficiency anemia. Am J Hematol. 2026.",
      "url": "https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.70433",
      "report_type": "Original article on non-oral routes",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical abstract on three non-oral routes: intranasal/IM/IV; not oral-regimen results",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S14-M1",
          "url": null,
          "parent_url": "https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.70433"
        },
        {
          "material_type": "Publisher-indexed abstract excerpt",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S14-M2",
          "url": "https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.70433",
          "parent_url": "https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.70433"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.70433"
        }
      ]
    },
    {
      "report_id": "S15",
      "title": "Wang et al. Cochrane review: oral vs IM B12. 2018.",
      "url": "https://www.cochrane.org/evidence/CD004655_oral-vitamin-b12-compared-intramuscular-vitamin-b12-vitamin-b12-deficiency",
      "report_type": "Official review summary",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Review",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical verification limited to search/included-trial summaries; full review inaccessible; not counted as an independent trial",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S15-M1",
          "url": null,
          "parent_url": "https://www.cochrane.org/evidence/CD004655_oral-vitamin-b12-compared-intramuscular-vitamin-b12-vitamin-b12-deficiency"
        },
        {
          "material_type": "Official review summary",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S15-M2",
          "url": "https://www.cochrane.org/evidence/CD004655_oral-vitamin-b12-compared-intramuscular-vitamin-b12-vitamin-b12-deficiency",
          "parent_url": "https://www.cochrane.org/evidence/CD004655_oral-vitamin-b12-compared-intramuscular-vitamin-b12-vitamin-b12-deficiency"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.cochrane.org/evidence/CD004655_oral-vitamin-b12-compared-intramuscular-vitamin-b12-vitamin-b12-deficiency"
        }
      ]
    },
    {
      "report_id": "S16",
      "title": "NICE NG239 Evidence review E: vitamin B12 replacement. 2024.",
      "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/",
      "report_type": "Official guideline evidence review",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Review",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historically accessed full text of NICE evidence/exclusion tables and appendix links; not a new direct trial",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S16-M1",
          "url": null,
          "parent_url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/"
        },
        {
          "material_type": "Official guideline evidence-review HTML",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S16-M2",
          "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/",
          "parent_url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/"
        }
      ]
    },
    {
      "report_id": "S17",
      "title": "NICE NG239 evidence review E Appendix D evidence tables",
      "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/bin/niceng239er5-appd-et1.pdf",
      "report_type": "Evidence-table PDF",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Review-appendix",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical visual check of Castelli metadata on the first page of the NICE appendix; not extended to reading the entire appendix",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S17-M1",
          "url": null,
          "parent_url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/bin/niceng239er5-appd-et1.pdf"
        },
        {
          "material_type": "Official evidence-review appendix PDF",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S17-M2",
          "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/bin/niceng239er5-appd-et1.pdf",
          "parent_url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/bin/niceng239er5-appd-et1.pdf"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.ncbi.nlm.nih.gov/books/NBK603292/bin/niceng239er5-appd-et1.pdf"
        }
      ]
    },
    {
      "report_id": "S18",
      "title": "Efficacy of different routes of vitamin B12 supplementation: systematic review/network meta-analysis. Irish J Med Sci.",
      "url": "https://link.springer.com/article/10.1007/s11845-023-03602-4",
      "report_type": "Systematic/network literature map",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Review",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical review full text mapping literature by route/population; not counted as replication of the same ampule+fruit juice day-90 Hb result",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S18-M1",
          "url": null,
          "parent_url": "https://link.springer.com/article/10.1007/s11845-023-03602-4"
        },
        {
          "material_type": "Publisher review HTML",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S18-M2",
          "url": "https://link.springer.com/article/10.1007/s11845-023-03602-4",
          "parent_url": "https://link.springer.com/article/10.1007/s11845-023-03602-4"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://link.springer.com/article/10.1007/s11845-023-03602-4"
        }
      ]
    },
    {
      "report_id": "S19",
      "title": "Vitamin B12 Administration. Middle East Journal of Family Medicine. May2024.",
      "url": "https://www.mejfm.com/May%202024/Vitamin%20B12%20Administration.pdf",
      "report_type": "Unfavorable literature-map lead",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Review-underlying evidence unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Preserve the search excerpt favoring injections for Hb, but the document was inaccessible and the underlying trial is unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S19-M1",
          "url": null,
          "parent_url": "https://www.mejfm.com/May%202024/Vitamin%20B12%20Administration.pdf"
        },
        {
          "material_type": "Review search excerpt",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S19-M2",
          "url": "https://www.mejfm.com/May%202024/Vitamin%20B12%20Administration.pdf",
          "parent_url": "https://www.mejfm.com/May%202024/Vitamin%20B12%20Administration.pdf"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.mejfm.com/May%202024/Vitamin%20B12%20Administration.pdf"
        }
      ]
    },
    {
      "report_id": "S20",
      "title": "NIH ODS Vitamin B12 Health Professional Fact Sheet",
      "url": "https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/",
      "report_type": "Safety explanatory material",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Official explanatory material",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical official explanation of no established B12 UL/drug interactions; not a guarantee of unlimited safety or an incidence estimate",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S20-M1",
          "url": null,
          "parent_url": "https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/"
        },
        {
          "material_type": "NIH ODS official HTML",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S20-M2",
          "url": "https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/",
          "parent_url": "https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/"
        }
      ]
    },
    {
      "report_id": "S21",
      "title": "MHRA: hydroxocobalamin/cyanocobalamin and cobalt allergy. 18Dec2023.",
      "url": "https://www.gov.uk/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions",
      "report_type": "Cobalt-sensitivity notice",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Official notice",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical hydroxo/cyano cobalt-sensitivity notice; not new independent events/incidence",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S21-M1",
          "url": null,
          "parent_url": "https://www.gov.uk/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions"
        },
        {
          "material_type": "MHRA official safety notice",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S21-M2",
          "url": "https://www.gov.uk/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions",
          "parent_url": "https://www.gov.uk/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.gov.uk/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions"
        }
      ]
    },
    {
      "report_id": "S22",
      "title": "DailyMed Cyanocobalamin injection label",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6",
      "report_type": "Cyanocobalamin injection label",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Official label",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Specify the injection scope, including Leber/early hypokalemia during intensive treatment; no transfer into oral-treatment incidence",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S22-M1",
          "url": null,
          "parent_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6"
        },
        {
          "material_type": "DailyMed official injection label",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S22-M2",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6",
          "parent_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6"
        }
      ]
    },
    {
      "report_id": "S23",
      "title": "NCT01476007 registry access attempt",
      "url": "https://clinicaltrials.gov/study/NCT01476007",
      "report_type": "NCT access attempt",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Registration-unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical NCT01476007 JS shell; endpoint/version-history content unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S23-M1",
          "url": null,
          "parent_url": "https://clinicaltrials.gov/study/NCT01476007"
        },
        {
          "material_type": "ClinicalTrials.gov JS shell",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S23-M2",
          "url": "https://clinicaltrials.gov/study/NCT01476007",
          "parent_url": "https://clinicaltrials.gov/study/NCT01476007"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://clinicaltrials.gov/study/NCT01476007"
        }
      ]
    },
    {
      "report_id": "S24",
      "title": "NCT01832129 registry access attempt",
      "url": "https://clinicaltrials.gov/study/NCT01832129",
      "report_type": "NCT access attempt",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Registration-unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical NCT01832129 JS shell; endpoint/version-history content unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S24-M1",
          "url": null,
          "parent_url": "https://clinicaltrials.gov/study/NCT01832129"
        },
        {
          "material_type": "ClinicalTrials.gov JS shell",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S24-M2",
          "url": "https://clinicaltrials.gov/study/NCT01832129",
          "parent_url": "https://clinicaltrials.gov/study/NCT01832129"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://clinicaltrials.gov/study/NCT01832129"
        }
      ]
    },
    {
      "report_id": "S25",
      "title": "NCT01312831 registry access attempt",
      "url": "https://clinicaltrials.gov/study/NCT01312831",
      "report_type": "NCT access attempt",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Registration-unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical NCT01312831 JS shell; endpoint/version-history content unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S25-M1",
          "url": null,
          "parent_url": "https://clinicaltrials.gov/study/NCT01312831"
        },
        {
          "material_type": "ClinicalTrials.gov JS shell",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S25-M2",
          "url": "https://clinicaltrials.gov/study/NCT01312831",
          "parent_url": "https://clinicaltrials.gov/study/NCT01312831"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://clinicaltrials.gov/study/NCT01312831"
        }
      ]
    },
    {
      "report_id": "S26",
      "title": "NCT06983223 registry access attempt",
      "url": "https://clinicaltrials.gov/study/NCT06983223",
      "report_type": "NCT access attempt",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Registration-unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Historical NCT06983223 JS shell; endpoint/version-history content unverified",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S26-M1",
          "url": null,
          "parent_url": "https://clinicaltrials.gov/study/NCT06983223"
        },
        {
          "material_type": "ClinicalTrials.gov JS shell",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S26-M2",
          "url": "https://clinicaltrials.gov/study/NCT06983223",
          "parent_url": "https://clinicaltrials.gov/study/NCT06983223"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://clinicaltrials.gov/study/NCT06983223"
        }
      ]
    },
    {
      "report_id": "S27",
      "title": "OB12 supplementary material lead",
      "url": "https://bmjopen.bmj.com/content/bmjopen/10/8/e033687/DC1/embed/inline-supplementary-material-1.pdf?download=true",
      "report_type": "Supplementary URL lead",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "OB12-report linkage",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "The OB12 supplementary search pointer was historically unopened; not promoted to full-text acquisition/reading",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S27-M1",
          "url": null,
          "parent_url": "https://bmjopen.bmj.com/content/bmjopen/10/8/e033687/DC1/embed/inline-supplementary-material-1.pdf?download=true"
        },
        {
          "material_type": "Supplementary PDF search URL",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "Distinguish historical material types/reading scope from no access attempt/no reading in this review. The existence of a link is not verification of the original source in this review.",
          "material_id": "S27-M2",
          "url": "https://bmjopen.bmj.com/content/bmjopen/10/8/e033687/DC1/embed/inline-supplementary-material-1.pdf?download=true",
          "parent_url": "https://bmjopen.bmj.com/content/bmjopen/10/8/e033687/DC1/embed/inline-supplementary-material-1.pdf?download=true"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://bmjopen.bmj.com/content/bmjopen/10/8/e033687/DC1/embed/inline-supplementary-material-1.pdf?download=true"
        }
      ]
    },
    {
      "report_id": "S28",
      "title": "CTRI/2023/04/052112 targeted registration search",
      "url": "https://www.ijrcog.org/index.php/ijrcog/article/view/15153",
      "report_type": "CTRI lead within the article",
      "existence": "Retained bibliography/historical access records. Current external queries in this review: 0",
      "acquired_read": "Exact retained bibliographic records/linked summaries actually read; external original materials/older separate original sources not read in this review",
      "study_family": "Registration-unconfirmed",
      "independent_replication": "28 bibliographic records≠28 trials. Distinguish same-DOI/OB12 report links from other unconfirmed identities and review/safety/registry roles; no new trial/participant totals",
      "observed_result": "Article-reported CTRI/2023/04/052112; official record not obtained. The URL points to the original article, not directly to an official registry record",
      "result_level": "Explicit scope of historically retained bibliographic records/original summaries. Not new verification of clinical full texts in this review",
      "materials": [
        {
          "material_type": "Retained summary: bibliographic record, linked summary and historical access",
          "public_status": "Locally retained",
          "access_status": "Acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-05",
          "qualification": "Exact stored-summary pointers/values/SHA, not original bytes of clinical full texts",
          "material_id": "S28-M1",
          "url": null,
          "parent_url": "https://www.ijrcog.org/index.php/ijrcog/article/view/15153"
        },
        {
          "material_type": "Original article's registration mention/search lead",
          "public_status": "Unverified (external queries in this review: 0)",
          "access_status": "Access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-10-05",
          "qualification": "The URL is a lead to the original article's CTRI mention, not a direct link to the official registry record.",
          "material_id": "S28-M2",
          "url": null,
          "parent_url": "https://www.ijrcog.org/index.php/ijrcog/article/view/15153"
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.ijrcog.org/index.php/ijrcog/article/view/15153"
        }
      ]
    }
  ],
  "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": "Reuse of the methodological principles/editions from 1585 and actual byte copies of 5 HTML files. Not new reading of full methodological texts or application of an official tool in this review"
    },
    {
      "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": "Reuse of the methodological principles/editions from 1585 and actual byte copies of 5 HTML files. Not new reading of full methodological texts or application of an official tool in this review"
    },
    {
      "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": "Reuse of the methodological principles/editions from 1585 and actual byte copies of 5 HTML files. Not new reading of full methodological texts or application of an official tool in this review"
    },
    {
      "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": "Reuse of the methodological principles/editions from 1585 and actual byte copies of 5 HTML files. Not new reading of full methodological texts or application of an official tool in this review"
    },
    {
      "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": "Reuse of the methodological principles/editions from 1585 and actual byte copies of 5 HTML files. Not new reading of full methodological texts or application of an official tool in this review"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some actual retained information exists, but gaps remain in product/exposure/methods, original denominators/estimates/plans, harms/identity/original sources",
    "Unverified": "The required information/criterion cannot be established within this verification scope",
    "Review incomplete": "Original-material comparison/search was not performed within the authorized scope",
    "Not reported": "A scope-limited status indicating that the item was not stated in the specific material/section read",
    "Inaccessible": "Use only for material for which access was actually attempted and failed. Not assigned to the clinical materials in this review",
    "Insufficient eligible evidence": "Use only when, after reviewing relevant studies within the defined scope, evidence is insufficient to answer the criterion. Not applied across all items in this review",
    "Not applicable": "Extensions to optimal dosing, long-term outcomes, events or other products outside the selected day-90 Hb regimen comparison do not apply. Not a substitute for unverified actual inputs",
    "Conflicting information": "Use when materials that are difficult to reconcile for the same question, time point and analysis have been compared. Not assigned merely because review numbers differ",
    "Met": "Verification of the stated preservation, boundary, distinction or linkage criteria. Not new clinical efficacy verification, full-text reading or safety certification"
  },
  "study_overlap": {
    "state": "These are report links in the stored manuscript. TF-BOL2003 original article and index with the same DOI/PMID (S01, S02) / OB12 original article/protocol/unopened supplementary lead. Serum B12 normalization NI, different from S01 (S04, S05, S27) / Preserve the roles of other clinical candidates/reviews, official safety materials/labels and registry leads. Unconfirmed identities are not added as independent replications (S03, S06, S07, S08, S09, S10, S11, S12, S13, S14, S15, S16, S17, S18, S19, S20, S21, S22, S23, S24, S25, S26, S28). The retained boundary review records 1 independent unit for the main direct-comparison candidate. The total unique trial count and total participant count remain unverified. Verification of retained summaries is distinguished from not reading external original materials in this review; 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. TF-BOL2003 original article and index with the same DOI/PMID (S01, S02) / OB12 original article/protocol/unopened supplementary lead. Serum B12 normalization NI, different from S01 (S04, S05, S27) / Preserve the roles of other clinical candidates/reviews, official safety materials/labels and registry leads. Unconfirmed identities are not added as independent replications (S03, S06, S07, S08, S09, S10, S11, S12, S13, S14, S15, S16, S17, S18, S19, S20, S21, S22, S23, S24, S25, S26, S28). The retained boundary review records 1 independent unit for the main direct-comparison candidate. The total unique trial count and total participant count remain unverified. Verification of stored summaries is distinguished from not reading external original materials in this review; report/family labels are not summed into total trial or participant counts."
  },
  "history": [
    {
      "date": "2026-11-05",
      "kind": "Separation of public-facing display and data",
      "view_version": "1.0",
      "change": "The public-facing display and data were created from the existing 47 items. No new clinical searches, changes to verification statuses or scoring were performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-11-05"
}