{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v3095-main",
  "verdict_number": "3095",
  "title": "Oral vitamin B6-only tablets (exact vitamer and salt unverified in the main trial) × Reduction of overall symptom severity in diagnosed PMS",
  "view_version": "1.0",
  "view_created_date": "2026-11-01",
  "criteria_version": "NGM-v3095-B6-MONOTHERAPY-PMS-GLOBAL-SEVERITY-1.0",
  "criteria_date": "2026-10-05",
  "review_date": "2026-10-05",
  "legacy_evidence_date": "2026-09-15",
  "review_scope": {
    "materials_read": "Archived Korean and English manuscripts and case-specific condition and application records",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "No external clinical abstracts, full texts, registrations, or analysis plans were newly read. Historical access records are distinguished from the reading of archived summaries in this review. The original assessment, numbers, and unresolved matters are preserved; no new search, calculation, or reassessment was performed.",
    "date_meaning": "This is the date the archived material was checked, not the date of a search for the latest clinical literature."
  },
  "claim_context": {
    "population": "Nonpregnant adults with PMS; main trial ages 18–45 with prospective symptom diaries; deficiency status and detailed differentiation from PMDD unverified",
    "intervention": "Vitamin B6 alone; vitamer and salt unverified in the main trial · Oral tablets; brand, crystal form, release form, and batch unverified · Oral",
    "dose": "Daily total dose unverified: conflicting descriptions of tablet strength in the main trial; B6 dose not reported in the supportive trial",
    "comparator": "Placebo; lactose and cellulose in the main trial; fixed common drug regimen unverified",
    "endpoint": "Main trial total score from a 12-symptom diary; registered outcome hierarchy and aggregation range unverified; lower is better",
    "duration": "2 diagnostic recording cycles followed by 2 treatment cycles; administration throughout the cycle",
    "excluded_extensions": "PMDD, pregnancy nausea, individual emotional/anxiety symptoms, mastalgia, combination products, active comparators, and other scales/distinct studies are not combined as the same effect on the current overall score. OR, end-of-treatment difference, arithmetic change contrast, the carried-forward 80 mg record, and MCID are each kept distinct."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Which population, intervention, comparator, and endpoint define the distinct claim?",
      "needed": "Dated records linking the original claim to the actual eligibility criteria, comparison, and endpoint",
      "role": "Required",
      "role_reason": "The current overall-symptom comparison must be separated from the historical claim that combined PMS and pregnancy nausea.",
      "application_exception": "Evidence for PMDD, individual emotional symptoms, mastalgia, or pregnancy nausea is not transferred to the current claim.",
      "criterion": "The current /ko/effect is linked to the boundaries of nonpregnant PMS, oral B6 monotherapy, placebo, and overall symptom score.",
      "basis": "C01: question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are self-designed / C04: M03 §3.2.1; detailed population conditions are self-designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed. Reason for applying these to this overall PMS score comparison: the current overall-symptom comparison must be separated from the historical claim that combined PMS and pregnancy nausea. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the current manuscript with each trial's population, intervention, comparator, and endpoint, and record the reason for a change only if a boundary has changed.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The original claim is “reduction of overall symptom severity in diagnosed PMS.” Oral B6-only tablets are compared with placebo in nonpregnant adults; PMDD, pregnancy nausea, and individual symptoms are not the direct claim.",
      "condition_status": "Met",
      "status_reason": "The scope and identity conditions are met. This does not mean that symptom improvement or the efficacy of a particular dose has been established.",
      "missingness": "Dated records linking the original claim to the actual eligibility criteria, comparison, and endpoint",
      "uncertainty": "Dated records linking the original claim to the actual eligibility criteria, comparison, and endpoint: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Dated records linking the original claim to the actual eligibility criteria, comparison, and endpoint"
    },
    {
      "item_id": "N02",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the prospectively confirmed PMS population, modern diagnostic assessment, and differentiation from PMDD verified?",
      "needed": "Inclusion and exclusion criteria, actual diagnostic diaries, and information on PMDD differentiation and baseline nutritional status",
      "role": "Required",
      "role_reason": "Self-reported premenstrual symptoms and diagnosed PMS or PMDD cannot be treated as the same population.",
      "application_exception": "Unverified diagnostic details are not taken to mean that no PMS population exists or that treatment is ineffective for PMDD.",
      "criterion": "The diagnostic cycles, participant ages and selection, differentiation from PMDD, and baseline nutritional status are linked to actual records.",
      "basis": "C04: M03 §3.2.1; detailed population conditions are self-designed / E08: M03 §3.2.1–3.2.4; details on dose, duration, and effect modification are self-designed. Reason for applying these to this overall PMS score comparison: self-reported premenstrual symptoms and diagnosed PMS or PMDD cannot be treated as the same population. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "First compare the diagnostic procedures across trials, then examine comparative records for PMS populations confirmed using the same definition.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial involved nonpregnant adults aged 18–45 and used prospective diaries over two diagnostic cycles. Deficiency status, detailed differentiation from PMDD, and modern diagnostic adjudication remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "The diaries and age range are preserved, but the detailed diagnosis and baseline status have not all been verified.",
      "missingness": "Inclusion and exclusion criteria, actual diagnostic diaries, and information on PMDD differentiation and baseline nutritional status",
      "uncertainty": "Inclusion and exclusion criteria, actual diagnostic diaries, and information on PMDD differentiation and baseline nutritional status: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Inclusion and exclusion criteria, actual diagnostic diaries, and information on PMDD differentiation and baseline nutritional status"
    },
    {
      "item_id": "N03",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is the main trial's B6-only arm distinguished from the Hypericum and placebo arms?",
      "needed": "Original records of each arm's intervention list, regimen, and comparator composition",
      "role": "Required",
      "role_reason": "Reading the two ingredients in the paper's title as a combination regimen changes the attribution of the intervention's contribution.",
      "application_exception": "The use of Hypericum in another arm is not taken to imply concurrent administration in the B6-only arm.",
      "criterion": "The actual parallel-arm composition is distinguished from the B6-versus-placebo comparison to be used in this table.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / E01: M08 §8.1–8.2.3; self-applied / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; self-applied. Reason for applying these to this overall PMS score comparison: reading the two ingredients in the paper's title as a combination regimen changes the attribution of the intervention's contribution. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Check the interventions table by arm and classify monotherapy, combination therapy, and comparisons with other ingredients separately.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S03 has separate parallel arms for B6 alone, Hypericum, and placebo. The current comparison uses only B6 and placebo and does not add the effect of Hypericum.",
      "condition_status": "Met",
      "status_reason": "The arm composition and attribution of the selected comparison are preserved. The conditions for verifying allocation concealment and dose have not thereby also been met.",
      "missingness": "Original records of each arm's intervention list, regimen, and comparator composition",
      "uncertainty": "Original records of each arm's intervention list, regimen, and comparator composition: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original records of each arm's intervention list, regimen, and comparator composition"
    },
    {
      "item_id": "N04",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the vitamer and salt of B6 in the key trials verified?",
      "needed": "Product ingredient lists, manufacturing specifications, and vitamer and salt records for the key trials",
      "role": "Required",
      "role_reason": "Pyridoxine, pyridoxal, PLP, and salts cannot be recast as chemically identical exposures.",
      "application_exception": "The trial's salt is not filled in from common commercial products or general NIH descriptions.",
      "criterion": "Verify the vitamer and salt of the product actually administered using trial-specific documents or manufacturing records.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed. Reason for applying this to this overall PMS score comparison: pyridoxine, pyridoxal, PLP, and salts cannot be recast as chemically identical exposures. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Cross-check the original trial's product identity records, and examine records for other vitamers as distinct exposures.",
      "current_reports": [
        "S02",
        "S03",
        "S15"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The exact vitamer and salt in the key trials remain unverified. The manuscript states that B6 is not the name of a single molecule and that pyridoxine, pyridoxal, and PLP were not treated as identical.",
      "condition_status": "Unverified",
      "status_reason": "General ingredient descriptions do not establish the identity of the actual trial product.",
      "missingness": "Product ingredient lists, manufacturing specifications, and vitamer and salt records for the key trials",
      "uncertainty": "Product ingredient lists, manufacturing specifications, and vitamer and salt records for the key trials: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Product ingredient lists, manufacturing specifications, and vitamer and salt records for the key trials"
    },
    {
      "item_id": "N05",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are details of the actual tablets, such as brand, origin, batch, and release form, verified?",
      "needed": "Manufacturing, product, batch, and release-form specifications for the administered tablets",
      "role": "Required",
      "role_reason": "The fact that a product is an oral tablet alone does not establish equivalence in release, strength, or manufacturing conditions.",
      "application_exception": "Unverified origin or brand is not converted into a finding that another product lacks efficacy.",
      "criterion": "Verify the oral route and actual product, batch, and release form, and distinguish the unverified dimensions.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed. Reason for applying this to this overall PMS score comparison: the fact that a product is an oral tablet alone does not establish equivalence in release, strength, or manufacturing conditions. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Obtain trial-product documents to examine differences between formulations; do not substitute another commercial product.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The route is oral and the formulation is a tablet. Manufacturing origin, brand, crystal form, release form, and batch remain unverified or inconsistently described.",
      "condition_status": "Partly verified",
      "status_reason": "Only the route and broad formulation have been verified; detailed product equivalence has not been established.",
      "missingness": "Manufacturing, product, batch, and release-form specifications for the administered tablets",
      "uncertainty": "Manufacturing, product, batch, and release-form specifications for the administered tablets: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Manufacturing, product, batch, and release-form specifications for the administered tablets"
    },
    {
      "item_id": "N06",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the main trial's tablet strength and total daily dose consistently verified?",
      "needed": "Author confirmation of the conflicting original strength statements, dosing table, number of tablets per administration, frequency, and total daily dose",
      "role": "Required",
      "role_reason": "Conflicting descriptions of the study dose limit interpretation of the actual exposure and dose.",
      "application_exception": "Do not reconstruct numbers absent from the conflicting original statements or use the study dose as dosing instructions.",
      "criterion": "Tablet strength, number of tablets, frequency, total daily dose, and the basis for conversion are linked consistently.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / E08: M03 §3.2.1–3.2.4; details on dose, duration, and effect modification are self-designed. Reason for applying these to this overall PMS score comparison: conflicting descriptions of the study dose limit interpretation of the actual exposure and dose. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the original dosing documents and revision history to verify a consistent exposure record, without calculating a new dose.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial's tablet-strength descriptions conflict, leaving the total daily dose unverified. The currently retained archived summary preserves the fact of the conflict, but does not contain the specific conflicting tablet-strength numbers or original statements.",
      "condition_status": "Conflicting records",
      "status_reason": "Consistency of the actual daily dose remains unresolved. Successfully recording the conflict is distinguished from verifying the exposure.",
      "missingness": "Author confirmation of the conflicting original strength statements, dosing table, number of tablets per administration, frequency, and total daily dose",
      "uncertainty": "Author confirmation of the conflicting original strength statements, dosing table, number of tablets per administration, frequency, and total daily dose: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Author confirmation of the conflicting original strength statements, dosing table, number of tablets per administration, frequency, and total daily dose"
    },
    {
      "item_id": "N07",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is the supportive trial's daily B6 dose verified separately from the magnesium dose of 250 mg?",
      "needed": "S02 records of the B6 dosing regimen and product, and the original dose statement",
      "role": "Required",
      "role_reason": "Transferring the magnesium amount from another arm to the B6 dose misattributes the product and exposure.",
      "application_exception": "250 mg is not relabeled as a B6 value. The absence of reporting is not generalized to the entire full text, which was not read in this review.",
      "criterion": "In S02, verify the actual B6 amount at its original location, and keep it separate from the magnesium dose.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; self-applied. Reason for applying these to this overall PMS score comparison: transferring the magnesium amount from another arm to the B6 dose misattributes the product and exposure. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the regimens by arm in S02 and extract the magnesium and B6 values separately.",
      "current_reports": [
        "S02"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The retained S02 content explicitly states that the B6 dose could not be verified in the report. 250 mg refers to magnesium, not the daily dose in the B6-only arm.",
      "condition_status": "Not reported",
      "status_reason": "The dose is described as not reported only within the supportive trial report content obtained at the time. This is not the result of a new check of the entire full text.",
      "missingness": "S02 records of the B6 dosing regimen and product, and the original dose statement",
      "uncertainty": "S02 records of the B6 dosing regimen and product, and the original dose statement: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "S02 records of the B6 dosing regimen and product, and the original dose statement"
    },
    {
      "item_id": "N08",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the diagnostic and treatment cycles and information on actual administration and adherence verified?",
      "needed": "Cycle-specific records of administration, adherence, discontinuation, and rescue treatment",
      "role": "Required",
      "role_reason": "Diagnostic records across menstrual cycles must be separated from treatment exposure and the period of adherence.",
      "application_exception": "The two cycles are not converted into a fixed number of days or an optimal treatment duration.",
      "criterion": "Verify the two diagnostic cycles, two treatment cycles, administration throughout the cycle, and actual adherence and discontinuation as distinct matters.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; self-applied / E08: M03 §3.2.1–3.2.4; details on dose, duration, and effect modification are self-designed. Reason for applying these to this overall PMS score comparison: diagnostic records across menstrual cycles must be separated from treatment exposure and the period of adherence. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the cycle schedule with actual administration records and examine deviations in relation to the actual effect of interest.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial is preserved as 2 diagnostic recording cycles followed by 2 treatment cycles, with administration throughout the cycle. Actual adherence and arm-specific discontinuation and dosing changes remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "A nominal cycle schedule is available, but actual exposure received and adherence have not all been verified.",
      "missingness": "Cycle-specific records of administration, adherence, discontinuation, and rescue treatment",
      "uncertainty": "Cycle-specific records of administration, adherence, discontinuation, and rescue treatment: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Cycle-specific records of administration, adherence, discontinuation, and rescue treatment"
    },
    {
      "item_id": "N09",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is there direct evidence of sustained effects and long-term outcomes after treatment ends?",
      "needed": "Follow-up schedules after treatment discontinuation and comparative outcomes on the same overall-symptom scale",
      "role": "Supplementary; required for a claim of sustained effects",
      "role_reason": "Needed to avoid extending a symptom comparison over two treatment cycles to a claim of sustained long-term effects.",
      "application_exception": "A long-term trial is not made mandatory for every study addressing the current narrow question of two cycles.",
      "criterion": "Follow-up time points, post-discontinuation outcomes, and sustained effects are linked through separate direct evidence.",
      "basis": "E08: M03 §3.2.1–3.2.4; details on dose, duration, and effect modification are self-designed. Reason for applying this to this overall PMS score comparison: this is needed to avoid extending a symptom comparison over two treatment cycles to a claim of sustained long-term effects. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Define sustained effects as a separate question and examine comparative follow-up records after discontinuation.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The current manuscript leaves sustained long-term effects unverified. It does not claim that effects persisting after discontinuation have been verified from the two-treatment-cycle comparison alone.",
      "condition_status": "Unverified",
      "status_reason": "The currently archived material contains no direct estimate of sustained effects or follow-up information.",
      "missingness": "Follow-up schedules after treatment discontinuation and comparative outcomes on the same overall-symptom scale",
      "uncertainty": "Follow-up schedules after treatment discontinuation and comparative outcomes on the same overall-symptom scale: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Follow-up schedules after treatment discontinuation and comparative outcomes on the same overall-symptom scale"
    },
    {
      "item_id": "N10",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is the actual comparison in terms of placebo, common drug regimens, and concomitant treatments verified?",
      "needed": "Placebo manufacturing records and arm-specific records of medicines, supplements, rescue treatment, and changes",
      "role": "Required",
      "role_reason": "Needed to avoid attributing differences in background treatment to an additional effect of B6 monotherapy.",
      "application_exception": "Do not assume that all changes in both arms are identical or fill an unverified field with an assertion of no concomitant treatment.",
      "criterion": "Distinguish placebo composition and common treatment from arm-specific concomitant treatments and changes using actual records.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are self-designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; self-applied. Reason for applying these to this overall PMS score comparison: this is needed to avoid attributing differences in background treatment to an additional effect of B6 monotherapy. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Cross-check the actual comparator composition and background treatment to examine attribution of intervention differences.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial's placebo is preserved as lactose and cellulose. The fixed common drug regimen and arm-specific concomitant and rescue treatments remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "Placebo composition has been verified, but the influence of other treatments and equivalence of background treatment have not all been verified.",
      "missingness": "Placebo manufacturing records and arm-specific records of medicines, supplements, rescue treatment, and changes",
      "uncertainty": "Placebo manufacturing records and arm-specific records of medicines, supplements, rescue treatment, and changes: limited to the currently retained record, with no new assessment of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Placebo manufacturing records and arm-specific records of medicines, supplements, rescue treatment, and changes"
    },
    {
      "item_id": "N11",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the allocation process, allocation concealment, and baseline balance verified?",
      "needed": "Allocation sequence, concealment procedures, arm-specific baseline characteristics, and participant-flow records",
      "role": "Required",
      "role_reason": "An RCT label alone does not establish that errors in the allocation process or confounding have been resolved.",
      "application_exception": "Do not assert that unverified allocation concealment was actually absent.",
      "criterion": "The random sequence, concealment, selection stages, and baseline balance relevant to the outcome are linked to their actual source locations.",
      "basis": "E01: M08 §8.1–8.2.3; custom application. Reason for applying this to the PMS total-score comparison: an RCT label alone does not establish that allocation errors or confounding have been resolved. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the original methods and allocation records with baseline characteristics relevant to the outcome, and record what was actually verified.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial is preserved as a parallel-group design, and baseline total scores are also available. Unverified allocation concealment or registration was not asserted to be actual absence; detailed allocation and analysis flow remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "Some design and score information is available, but the sequence, concealment, and overall baseline balance could not all be verified.",
      "missingness": "Allocation sequence, concealment procedures, arm-specific baseline characteristics, and participant-flow records",
      "uncertainty": "Allocation sequence, concealment procedures, baseline characteristics by group, and flow data; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Allocation sequence, concealment procedures, arm-specific baseline characteristics, and participant-flow records"
    },
    {
      "item_id": "N12",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are blinding and collection procedures by group verified for the subjective diary assessment?",
      "needed": "Diary collection manual, blinding, assessment, and measurement schedules by group",
      "role": "Required",
      "role_reason": "For patient-reported endpoints, differences in expectations or collection procedures may be reflected in the total score.",
      "application_exception": "Do not use unverified blinding information to establish blinding failure or the magnitude of bias.",
      "criterion": "Verify the actual procedures for diary completion, collection timing, assessors, and blinding by group.",
      "basis": "E03: M08 Table 8.2.a, M03 §3.2.4; custom application. Reason for applying this to the PMS total-score comparison: for patient-reported endpoints, differences in expectations or collection procedures may be reflected in the total score. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the methods section with the diary procedures and review the actual collection limitations for the subjective endpoint.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The currently archived material identifies a 12-symptom diary endpoint but does not contain specific details of how blinding was implemented or how diaries were collected by group.",
      "condition_status": "Unverified",
      "status_reason": "Details of the measurement procedures cannot be verified within the summaries and structure currently saved.",
      "missingness": "Diary collection manual, blinding, assessment, and measurement schedules by group",
      "uncertainty": "Diary collection manual, blinding, assessment, and measurement schedules by group; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Diary collection manual, blinding, assessment, and measurement schedules by group"
    },
    {
      "item_id": "N13",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the definition, direction, and aggregation range of the total 12-symptom diary score verified?",
      "needed": "Original diary, scoring sheet, aggregation and normalization specifications, and scale validation materials",
      "role": "Required",
      "role_reason": "This is needed to avoid treating the study-specific total score as the modern DRSP or an individual emotional-symptom score.",
      "application_exception": "Do not call the older diary DRSP or transfer significance in a subdomain to the overall endpoint.",
      "criterion": "Verify the direction, composition, aggregation range, and scale name of the 12-symptom total score against the actual material.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed / E03: M08 Table 8.2.a, M03 §3.2.4; custom application. Reason for applying this to the PMS total-score comparison: this is needed to avoid treating the study-specific total score as the modern DRSP or an individual emotional-symptom score. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the original score definitions and distinguish the total score from subdomains and other scales.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial uses the total score of a 12-symptom diary, with lower scores indicating better outcomes. Total-score normalization and aggregation range remain unverified, and the manuscript does not call the older scale DRSP.",
      "condition_status": "Partly verified",
      "status_reason": "The composition and direction are preserved, but a reproducible definition of the total-score calculation remains incomplete.",
      "missingness": "Original diary, scoring sheet, aggregation and normalization specifications, and scale validation materials",
      "uncertainty": "Original diary, scoring sheet, aggregation and normalization specifications, and scale validation materials; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original diary, scoring sheet, aggregation and normalization specifications, and scale validation materials"
    },
    {
      "item_id": "N14",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Can the total-score calculation and normalization be verified reproducibly?",
      "needed": "Raw symptom scores, calculation formula, and rules for missing data and normalization",
      "role": "Required",
      "role_reason": "Even when means are available, interpretation of the measurement remains limited if the process used to generate the total score is unknown.",
      "application_exception": "Do not reassess the original historical B2 determination with a new score; distinguish verified reporting defects from unverified information.",
      "criterion": "The calculation, missing-data handling, and normalization methods from individual symptom records through to the total score are verified.",
      "basis": "E03: M08 Table 8.2.a, M03 §3.2.4; custom application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed. Reason for applying this to the PMS total-score comparison: even when means are available, interpretation of the measurement remains limited if the process used to generate the total score is unknown. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the score-calculation documentation with the original table to review interpretability, without calculating a new score.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The original B2 rationale identifies a reporting and measurement problem: the explanation of total-score calculation and normalization is insufficiently reproducible. The currently archived summary does not contain the calculation formula.",
      "condition_status": "Unverified",
      "status_reason": "The process used to generate the score cannot be reproduced within the currently preserved material.",
      "missingness": "Raw symptom scores, calculation formula, and rules for missing data and normalization",
      "uncertainty": "Raw symptom scores, calculation formula, and rules for missing data and normalization; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Raw symptom scores, calculation formula, and rules for missing data and normalization"
    },
    {
      "item_id": "N15",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Were the primary-endpoint hierarchy, timing, and analysis plan specified in advance?",
      "needed": "Dated registration, protocol, and analysis plan, and the results table for the overall endpoint",
      "role": "Required",
      "role_reason": "The presence of a total score in the paper does not verify its registered hierarchy.",
      "application_exception": "Do not treat failure to obtain the registration as confirmation of nonregistration or selective reporting.",
      "criterion": "The dates, total score, timing, and hierarchy in the registration, protocol, and analysis plan are compared with the actual report.",
      "basis": "E06: M08 Table 8.2.a, M04 §4.6.3; custom application. Reason for applying this to the PMS total-score comparison: the presence of a total score in the paper does not verify its registered hierarchy. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare plan versions and dates with the actual overall endpoint and analysis, and record what remains unchecked.",
      "current_reports": [
        "S02",
        "S03",
        "S18"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The registered hierarchy of the main trial's total score remains unverified. S02 has the identifier IRCT201106216854N1, but registration details, history, and whether registration was prospective could not be verified.",
      "condition_status": "Unverified",
      "status_reason": "The existence of an identifier alone cannot verify agreement between the prospective plan and the actual report.",
      "missingness": "Dated registration, protocol, and analysis plan, and the results table for the overall endpoint",
      "uncertainty": "Dated registration, protocol, and analysis plan, and the results table for the overall endpoint; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Dated registration, protocol, and analysis plan, and the results table for the overall endpoint"
    },
    {
      "item_id": "N16",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Can the flow of recruited, allocated, and analysed participants in the main trial be verified consistently?",
      "needed": "Conflicting recruitment, allocation, completion, and analysis flow diagrams, and reasons for exclusion by group",
      "role": "Required",
      "role_reason": "Using the table's 78 participants per group as overall recruitment or allocation counts changes which stage the denominator belongs to.",
      "application_exception": "Do not invent specific overall participant counts from the abstract, Methods, or tables that are absent from the currently archived summary.",
      "criterion": "Recruitment, allocation, completion, and analysis flow, and reasons for exclusion, are linked consistently across the abstract, methods, and tables.",
      "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed / E01: M08 §8.1–8.2.3; custom application / E04: M08 §8.2.2, M15 §15.3.1; custom application. Reason for applying this to the PMS total-score comparison: using the table's 78 participants per group as overall recruitment or allocation counts changes which stage the denominator belongs to. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Link each stage-specific and endpoint-specific denominator to its original location to check consistency only, without creating new participant totals.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The table analysis headers show B6 78 participants and placebo 78 participants. The manuscript states that internally inconsistent participant accounting across the abstract, methods, and tables makes a coherent analysis-population check difficult. Detailed recruitment and allocation counts are absent from the current summary.",
      "condition_status": "Conflicting records",
      "status_reason": "The actual inconsistency in denominator flow remains unresolved, and the table denominators are not transferred to other stages.",
      "missingness": "Conflicting recruitment, allocation, completion, and analysis flow diagrams, and reasons for exclusion by group",
      "uncertainty": "Conflicting recruitment, allocation, completion, and analysis flow diagrams, and reasons for exclusion by group; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Conflicting recruitment, allocation, completion, and analysis flow diagrams, and reasons for exclusion by group"
    },
    {
      "item_id": "N17",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Do the baseline and end-of-treatment means, SDs, and denominators in the main trial table belong to the specified total score?",
      "needed": "Original total-score table, definitions of dispersion for each value, and endpoint-specific analysis headers",
      "role": "Required",
      "role_reason": "This is needed to preserve the original table's means, dispersion, and analysis headers without transferring them to other endpoints or stages.",
      "application_exception": "Do not change SD to SE or use the 78 participants per group as the overall allocation count.",
      "criterion": "The four means, four SDs, analysis headers by group, and direction of the total score in the currently preserved original table are accurately linked.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed / E04: M08 §8.2.2, M15 §15.3.1; custom application. Reason for applying this to the PMS total-score comparison: this is needed to preserve the original table's means, dispersion, and analysis headers without transferring them to other endpoints or stages. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Check the original locations of numbers, dispersion, and denominators, and preserve both the prior and revised values if corrections are made.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The preserved table shows B6 33.93(SD 6.95)→20.92(SD 5.26), placebo 33.86(SD 6.16)→23.90(SD 6.00), with analysis headers of 78 participants per group. All are study-specific total scores.",
      "condition_status": "Met",
      "status_reason": "The types, endpoints, and table-denominator attribution of the currently preserved numbers have been verified. This does not mean that the original full text was newly checked or that allocation flow was resolved.",
      "missingness": "Original total-score table, definitions of dispersion for each value, and endpoint-specific analysis headers",
      "uncertainty": "Original total-score table, definitions of dispersion for each value, and endpoint-specific analysis headers; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original total-score table, definitions of dispersion for each value, and endpoint-specific analysis headers"
    },
    {
      "item_id": "N18",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the preserved arithmetic change contrast and end-of-treatment difference distinguished from the formal adjusted effect?",
      "needed": "Original calculation records C03·C04, the original table, and specifications for the formal change-contrast analysis",
      "role": "Required",
      "role_reason": "This is needed to avoid treating the arithmetic contrast from reported means as the same estimator as a formal adjusted change contrast.",
      "application_exception": "Preserve the original historical values unchanged, without new calculations, imputation of correlations, or reconstruction of variances in this review.",
      "criterion": "The original attribution of the -3.05-point change contrast and -2.98-point end-of-treatment difference is kept separate from the unverified formal estimator.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed / E04: M08 §8.2.2, M15 §15.3.1; custom application / E05: M15 §15.3.1–15.3.3; custom application. Reason for applying this to the PMS total-score comparison: this is needed to avoid treating the arithmetic contrast from reported means as the same estimator as a formal adjusted change contrast. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Perform only a traceability review comparing historical calculations with formal results, without producing new arithmetic values or CIs.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "In the manuscript, -3.05 points is the historical arithmetic change contrast derived from reported means, and -2.98 points is the end-of-treatment difference. These are not a formal adjusted change contrast or its confidence interval, and they were not recalculated in this review.",
      "condition_status": "Met",
      "status_reason": "The type of historical arithmetic and its boundary with the formal estimator have been verified. This does not mean that the conditions for causal effect or precision have been met.",
      "missingness": "Original calculation records C03·C04, the original table, and specifications for the formal change-contrast analysis",
      "uncertainty": "Original calculation records C03·C04, the original table, and specifications for the formal change-contrast analysis; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original calculation records C03·C04, the original table, and specifications for the formal change-contrast analysis"
    },
    {
      "item_id": "N19",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the formal between-group change contrast, adjustment method, and confidence interval verified?",
      "needed": "Original change-contrast analysis results, model, analysis population, variance, and CI",
      "role": "Required",
      "role_reason": "A point estimate or end-of-treatment SD alone cannot establish the precision of the effect on change scores.",
      "application_exception": "Do not impute unverified correlations or variances, or treat an end-of-treatment interval as a change-contrast CI.",
      "criterion": "Verify the analysis population, adjustment, variance, CI, and actual timing of the between-group change contrast.",
      "basis": "E04: M08 §8.2.2, M15 §15.3.1; custom application / E05: M15 §15.3.1–15.3.3; custom application. Reason for applying this to the PMS total-score comparison: a point estimate or end-of-treatment SD alone cannot establish the precision of the effect on change scores. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the original results and analysis plan to verify the reported interval for the same estimator, without calculating a new interval.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "Formal change-contrast confidence intervals remain unverified for the main and supportive trials. The manuscript retains the limitations that ANCOVA was not reported and correlations or variances were not estimated.",
      "condition_status": "Unverified",
      "status_reason": "The formal change-contrast analysis and its interval cannot be verified within the currently preserved material.",
      "missingness": "Original change-contrast analysis results, model, analysis population, variance, and CI",
      "uncertainty": "Original change-contrast analysis results, model, analysis population, variance, and CI; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original change-contrast analysis results, model, analysis population, variance, and CI"
    },
    {
      "item_id": "N20",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is the B6-placebo between-group test of change verified separately from within-group tests and the overall three-group test?",
      "needed": "Original tests, post hoc contrasts, handling of multiplicity, and analysis plan",
      "role": "Required",
      "role_reason": "Within-group significance and the overall three-group test are not a test of the change contrast between the two selected groups.",
      "application_exception": "Do not reconstruct original P values or post hoc test values absent from the preserved archived summary, or treat nonsignificance as an effect of 0.",
      "criterion": "The test of the change contrast, contrasts, and handling of multiplicity for the two selected groups are verified at their actual source locations.",
      "basis": "E04: M08 §8.2.2, M15 §15.3.1; custom application / E06: M08 Table 8.2.a, M04 §4.6.3; custom application. Reason for applying this to the PMS total-score comparison: within-group significance and the overall three-group test are not a test of the change contrast between the two selected groups. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Identify the comparisons in the original test table and review within-group tests, the overall test, and the test of the two selected groups separately.",
      "current_reports": [
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The manuscript states that within-group significance or the overall three-group test result was not substituted for the exact B6-placebo test of the change contrast. The currently archived summary does not contain the specific P value of that original test.",
      "condition_status": "Unverified",
      "status_reason": "The limitations on test attribution have been preserved, but the exact test of change between the two groups and the handling of multiplicity remain unverified.",
      "missingness": "Original tests, post hoc contrasts, handling of multiplicity, and analysis plan",
      "uncertainty": "Original tests, post hoc contrasts, handling of multiplicity, and analysis plan; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Original tests, post hoc contrasts, handling of multiplicity, and analysis plan"
    },
    {
      "item_id": "N21",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the analysis population, missing data, attrition, and definition of the effect of interest verified?",
      "needed": "Endpoint-specific analysis populations, missing data, reasons for attrition, and ITT/PP and adjustment specifications",
      "role": "Required",
      "role_reason": "This is needed to avoid treating an analysis of completers as an effect of assignment or as ITT.",
      "application_exception": "Do not label an unknown analysis as ITT or PP, or treat missing data as 0.",
      "criterion": "Allocation, completion, and analysis by group are linked to missing-data handling and the effect of interest.",
      "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; custom application / E04: M08 §8.2.2, M15 §15.3.1; custom application. Reason for applying this to the PMS total-score comparison: this is needed to avoid treating an analysis of completers as an effect of assignment or as ITT. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the analysis plan and flow diagram with the result denominators to distinguish the effect being estimated.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "Detailed allocation and analysis flow remain unverified, and the main trial's table headers conflict with the overall participant-count description. In the supportive trial, completion counts and endpoint-specific analysis denominators may differ, so they are kept separate.",
      "condition_status": "Unverified",
      "status_reason": "Direct specifications of the effect of interest and missing-data handling could not be verified in the current summary.",
      "missingness": "Endpoint-specific analysis populations, missing data, reasons for attrition, and ITT/PP and adjustment specifications",
      "uncertainty": "Endpoint-specific analysis populations, missing data, reasons for attrition, and ITT/PP and adjustment specifications; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Endpoint-specific analysis populations, missing data, reasons for attrition, and ITT/PP and adjustment specifications"
    },
    {
      "item_id": "N22",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the supportive trial's allocation, completion, and endpoint denominators and its 30-symptom results distinguished?",
      "needed": "S02 endpoint-specific analysis headers, score tables, variance, missing data, and change-contrast results",
      "role": "Required",
      "role_reason": "Treating 42 allocated participants, 36/37 completers, and endpoint analysis counts as the same denominator changes the attribution of results.",
      "application_exception": "Do not establish completion counts as endpoint denominators or combine arithmetic contrasts from different scales.",
      "criterion": "Verify separately the original attribution of S02 allocation, completion, and endpoint analysis denominators and the 30-symptom score.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed / E04: M08 §8.2.2, M15 §15.3.1; custom application. Reason for applying this to the PMS total-score comparison: treating 42 allocated participants, 36/37 completers, and endpoint analysis counts as the same denominator changes the attribution of results. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the original tables with allocation, completion, and analysis kept as separate stages, without recalculating the currently preserved historical arithmetic.",
      "current_reports": [
        "S02"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S02 allocated 42 participants per group; completers were B6 36 and placebo 37. The 30-symptom diary values B6 36.51→22.84 and placebo 35.80→28.41, and the historical arithmetic contrast of -6.28 points, are preserved, but endpoint-specific analysis denominators and the between-group change CI remain unverified.",
      "condition_status": "Partly verified",
      "status_reason": "Allocation and completion counts and scores are available, but endpoint denominators, variance, and formal intervals could not be established.",
      "missingness": "S02 endpoint-specific analysis headers, score tables, variance, missing data, and change-contrast results",
      "uncertainty": "S02 endpoint-specific analysis headers, score tables, variance, missing data, and change-contrast results; scope is limited to the currently preserved record, with no new determination of clinical efficacy, individual probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "S02 endpoint-specific analysis headers, score tables, variance, missing data, and change-contrast results"
    },
    {
      "item_id": "N23",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is there evidence supporting conversion of the 12-symptom and 30-symptom scales for comparison in the same effect units?",
      "needed": "The two original scales, score ranges, validation, and evidence for the validity of conversion",
      "role": "Required",
      "role_reason": "Comparing numerical differences in different total scores as the same amount of improvement erases the differences between scales.",
      "application_exception": "Do not newly calculate a common scale, pooled result, or standardized effect.",
      "criterion": "Verify the composition, ranges, and validation of the two scales, and justified conversion to a common unit of interpretation.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed / E03: M08 Table 8.2.a, M03 §3.2.4; custom application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; custom application. Reason for applying this to the PMS total-score comparison: comparing numerical differences in different total scores as the same amount of improvement erases the differences between scales. No formal RoB2/GRADE/clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare results separately by scale, and do not combine them into a common effect without validated evidence supporting conversion.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The main trial uses a 12-symptom diary, and the supportive trial uses a separate 30-symptom diary. The manuscript does not combine -3.05 points and -6.28 points and provides no evidence supporting conversion to a common scale.",
      "condition_status": "Unverified",
      "status_reason": "The fact that the scales differ has been verified, but comparability in the same clinical units remains unverified.",
      "missingness": "The two original scales, score ranges, validation, and evidence for the validity of conversion",
      "uncertainty": "Materials on the two original scales, score ranges, validation, and validity of conversion. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "The two original scales, score ranges, validation, and evidence for the validity of conversion"
    },
    {
      "item_id": "N24",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Have the original Results location, scale, denominators, and dispersion for the carried-forward 80 mg/day values been recovered?",
      "needed": "The original Results location, scale, denominators by arm and stage, and dispersion for S06, together with the original C10 calculation record",
      "role": "Required",
      "role_reason": "This is needed to avoid upgrading numbers retained in the resumption request to newly verified original results or independent replication.",
      "application_exception": "Do not relabel 160 as the randomized count or 94 as a per-arm count, or invent an SD, CI, or P for -0.87 points.",
      "criterion": "The exact original Results location, scale, denominators by stage and arm, and dispersion are linked to the carried-forward values.",
      "basis": "C03: data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are custom designs / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are custom designs / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are custom designs / E05: M15 §15.3.1–15.3.3; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid upgrading numbers retained in the resumption request to newly verified original results or independent replication. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "First review the provenance of the existing numbers, and do not integrate them quantitatively before their identity and scope are recovered.",
      "current_reports": [
        "S06"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S06 preserves 80 mg/day, B6 -1.80 and placebo -0.93, an initial sample of 160 with 94 analysed, and the historical arithmetic change contrast of -0.87 points. The exact original Results location, scale, dispersion, and denominators by stage and arm remain unrecovered; these values were not used for grading or independent replication.",
      "condition_status": "Partly verified",
      "status_reason": "The carried-forward values and their limitations were preserved, but direct traceability to the original results and the analysis details could not be verified.",
      "missingness": "The original Results location, scale, denominators by arm and stage, and dispersion for S06, together with the original C10 calculation record",
      "uncertainty": "The original Results location, scale, denominators by arm and stage, and dispersion for S06, together with the original C10 calculation record. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "The original Results location, scale, denominators by arm and stage, and dispersion for S06, together with the original C10 calculation record"
    },
    {
      "item_id": "N25",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is the 2020 correction distinguished as an authorship change, an efficacy-number correction, or a retraction?",
      "needed": "The changes and author list in the correction document, and its link to the original article",
      "role": "Required",
      "role_reason": "This is needed to avoid interpreting a correction adding an author as a correction to result numbers or a retraction.",
      "application_exception": "Do not reassess the study effect or independence score solely because of an authorship change.",
      "criterion": "The actual type of correction event and its link to the original trial are stated explicitly.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is a custom design / C09: M04 §4.5, §4.6.3; limits on transitioning to current materials are based on the user's scope and custom design / E06: M08 Table 8.2.a, M04 §4.6.3; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid interpreting a correction adding an author as a correction to result numbers or a retraction. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare only the items changed by correction or retraction documents; review changes to the original numbers only when separately verified.",
      "current_reports": [
        "S06",
        "S07"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S07 is a 2020 correction adding the omitted author Shahnaz Babayanzad Ahari. It was not described as an efficacy-number correction or a retraction, and it belongs to the same trial publication family as S06.",
      "condition_status": "Met",
      "status_reason": "The correction type and trial relationship were distinguished in the retained record. The external full correction text has not been newly read in this review.",
      "missingness": "The changes and author list in the correction document, and its link to the original article",
      "uncertainty": "The changes and author list in the correction document, and its link to the original article. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "The changes and author list in the correction document, and its link to the original article"
    },
    {
      "item_id": "N26",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Do the 1999 review's 9 trials and 940 participants all represent the same eligible comparison?",
      "needed": "S01's included-trial table, interventions, populations, endpoints, and links to original reports",
      "role": "Required",
      "role_reason": "This is needed to avoid counting the review totals as independent repetitions of the same B6-only PMS trial comparison.",
      "application_exception": "Do not automatically remove multivitamin or mastalgia-only trials and then calculate a new eligible count.",
      "criterion": "Verify each included trial's ingredients, population, comparator, endpoints, and whether it shares a cohort with another trial report.",
      "basis": "C02: the distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a custom application / C04: M03 §3.2.1; detailed population conditions are custom designs / C05: M03 §3.2.2–3.2.3; reverse-direction flagging and test adaptations are custom designs / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid counting the review totals as independent repetitions of the same B6-only PMS trial comparison. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare the included trials against each question, and do not use review totals as the number of study families or the denominator for the current effect.",
      "current_reports": [
        "S01"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The review's 9 trials and 940 participants include multivitamin trials and trials assessing mastalgia alone. They do not all represent the same comparison of overall PMS symptoms with B6 monotherapy, and they are not added up as independent studies in the current table.",
      "condition_status": "Partly verified",
      "status_reason": "The heterogeneous inclusion scope was identified, but detailed eligibility and cohort relationships could not be established for every trial.",
      "missingness": "S01's included-trial table, interventions, populations, endpoints, and links to original reports",
      "uncertainty": "S01's included-trial table, interventions, populations, endpoints, and links to original reports. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "S01's included-trial table, interventions, populations, endpoints, and links to original reports"
    },
    {
      "item_id": "N27",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Can the definition, denominator, and comparator represented by the review's improvement OR 2.15 be verified?",
      "needed": "S01's definition of improvement, events in the monotherapy subgroup, comparator, denominators, and original OR table",
      "role": "Required",
      "role_reason": "This is needed to avoid reading an odds ratio for improvement as a percentage reduction in the total score or an individual's probability of success.",
      "application_exception": "Do not convert the OR to an RR, score change, or probability, or recalculate it.",
      "criterion": "Link the improvement definition, monotherapy subgroup, denominators, effect direction, and CI to the original material.",
      "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are custom designs / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are custom designs / E04: M08 §8.2.2, M15 §15.3.1; custom application / E05: M15 §15.3.1–15.3.3; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid reading an odds ratio for improvement as a percentage reduction in the total score or an individual's probability of success. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Link the review's categorical results to the original table and review them separately from score results, without recalculating effects.",
      "current_reports": [
        "S01"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "For the B6-only subgroup, an improvement OR of 2.15 (CI 1.79–2.59) is retained. It is not a percentage reduction in the overall symptom score or an individual's probability of improvement. The currently archived summary does not contain a table of improvement classifications or subgroup events and denominators.",
      "condition_status": "Partly verified",
      "status_reason": "The measure, subgroup, and interval are available, but traceability of the specific improvement definition and event denominators remains incomplete.",
      "missingness": "S01's definition of improvement, events in the monotherapy subgroup, comparator, denominators, and original OR table",
      "uncertainty": "S01's definition of improvement, events in the monotherapy subgroup, comparator, denominators, and original OR table. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "S01's definition of improvement, events in the monotherapy subgroup, comparator, denominators, and original OR table"
    },
    {
      "item_id": "N28",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are reports from the same trial, protocols, and possible cohort overlaps identified?",
      "needed": "A linkage table covering trial registration, sites, recruitment dates, participants, and reports, together with overlap materials",
      "role": "Required",
      "role_reason": "This is needed to avoid double-counting reports or protocols as independent trials.",
      "application_exception": "Do not turn unverified overlap into confirmed independence or a confirmed shared cohort.",
      "criterion": "Link the established relationships of S03/S11 and S08/S21 and the unverified relationship of S19/S02 to their respective original locations.",
      "basis": "C02: the distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a custom application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid double-counting reports or protocols as independent trials. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Link reports to trial families, distinguish confirmed, possible, and unknown relationships, and leave unverified unique participant counts blank.",
      "current_reports": [
        "S02",
        "S03",
        "S08",
        "S11",
        "S19",
        "S21"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S11 is grouped as an earlier partial report of S03, and S21 as the protocol for S08. Possible cohort overlap between S19 and S02 remains unverified, and it is not counted as independent replication of B6 monotherapy.",
      "condition_status": "Partly verified",
      "status_reason": "The two family links are present, but the actual cohort relationship of S19/S02 and the total unique participant count remain unverified.",
      "missingness": "A linkage table covering trial registration, sites, recruitment dates, participants, and reports, together with overlap materials",
      "uncertainty": "A linkage table covering trial registration, sites, recruitment dates, participants, and reports, together with overlap materials. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "A linkage table covering trial registration, sites, recruitment dates, participants, and reports, together with overlap materials"
    },
    {
      "item_id": "N29",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the boundaries between overall results that are not favorable, emotional-domain results, and other interventions identified?",
      "needed": "Overall and domain-specific outcome tables for each trial, with ingredients, comparators, and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "This is needed to avoid retaining only some favorable results or extrapolating emotional or anxiety domain results to overall PMS success.",
      "application_exception": "Do not convert nonsignificance or unverified overall results into an effect of 0 or equivalence.",
      "criterion": "The limited findings of Doll and Kendall and the roles of active comparators, combinations, and other interventions are distinguished from overall results.",
      "basis": "C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is a custom design / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; custom application / E09: M03 §3.2.4; custom limits on extrapolation. Reason for applying this to the overall PMS score comparison: this is needed to avoid retaining only some favorable results or extrapolating emotional or anxiety domain results to overall PMS success. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare favorable, no-difference, and unfavorable results as materials addressing the same question, while separating results for other endpoints or interventions.",
      "current_reports": [
        "S04",
        "S05",
        "S08",
        "S09",
        "S19",
        "S20"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "Doll's emotional-domain signal is not transferred to overall improvement. Kendall's original overall mean and CI remain unverified. S08 involves an active comparator and inclusion of riboflavin; S09 concerns anxiety with a combination; S19 is a combination study; and S20 has no B6 arm. These are kept separate from the direct overall effect.",
      "condition_status": "Partly verified",
      "status_reason": "Contrary and scope-limited materials were retained, but the complete original overall results and detailed comparisons in older studies have not all been verified.",
      "missingness": "Overall and domain-specific outcome tables for each trial, with ingredients, comparators, and endpoint-specific denominators",
      "uncertainty": "Overall and domain-specific outcome tables for each trial, with ingredients, comparators, and endpoint-specific denominators. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Overall and domain-specific outcome tables for each trial, with ingredients, comparators, and endpoint-specific denominators"
    },
    {
      "item_id": "N30",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are research funding, product supply, and conflict-of-interest declarations verified separately from independent funding?",
      "needed": "Trial-specific funding, product-supply agreements, author employment, patents, and COI declarations",
      "role": "Required; interpretation of independence",
      "role_reason": "A declaration of no conflicts of interest or pharmacy supply does not prove independent funding or independent replication.",
      "application_exception": "Do not turn unverified interests into confirmed independence or automatic exclusion.",
      "criterion": "For each trial, link the respective verified scope and unresolved details of funding, supply, and COI.",
      "basis": "C10: Chamgap's own independence and attribution conditions. The formal methods sections used in this pilot do not warrant all of these detailed items. Reason for applying this to the overall PMS score comparison: a declaration of no conflicts of interest or pharmacy supply does not prove independent funding or independent replication. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare declarations separately with actual funding and supply materials, and record the limits on interpreting independence.",
      "current_reports": [
        "S02",
        "S03",
        "S04",
        "S05",
        "S06"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "S03 distinguishes the authors' declaration of no COI from the unverified specific funding and B6 supplier. In S02, supply of coded tablets by the university pharmacy was verified, but funding and author COI remain unverified. Other trials likewise retain their unresolved details within the available material scope.",
      "condition_status": "Partly verified",
      "status_reason": "Some supply and declaration details are available, but independent funding and all supply and employment relationships could not be established.",
      "missingness": "Trial-specific funding, product-supply agreements, author employment, patents, and COI declarations",
      "uncertainty": "Trial-specific funding, product-supply agreements, author employment, patents, and COI declarations. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Trial-specific funding, product-supply agreements, author employment, patents, and COI declarations"
    },
    {
      "item_id": "N31",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are adverse-event collection, denominators, and follow-up verified for the same PMS population and exposure?",
      "needed": "Trial-specific AE definitions, collection, exposure denominators by arm, duration, and discontinuation materials",
      "role": "Supplementary; required for interpreting safety",
      "role_reason": "This is needed to avoid reading the absence of reported serious adverse events in a short trial as long-term safety.",
      "application_exception": "Do not delete efficacy materials or fill unreported harm counts or risks with 0.",
      "criterion": "Trial-specific AE definitions, systematic collection, exposure denominators, duration, and discontinuations are verified.",
      "basis": "E10: M19 §19.1.2–19.2.4; custom application / H01: M19 §19.1.2–19.2.4; detailed distinctions are custom designs / H04: M19 §19.1.2–19.2.4; custom application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; custom application. Reason for applying this to the overall PMS score comparison: this is needed to avoid reading the absence of reported serious adverse events in a short trial as long-term safety. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare efficacy and harm outcomes separately, and review follow-up and collection methods suited to neurological outcomes.",
      "current_reports": [
        "S02",
        "S03",
        "S12",
        "S13",
        "S14",
        "S16"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The original safety explanation states that the absence of reports of serious adverse events in short trials does not establish long-term neurological safety. The currently retained archived summary does not contain complete AE collection tables, denominators, or discontinuation results for each PMS comparison.",
      "condition_status": "Unverified",
      "status_reason": "A complete harm comparison for the same population, actual dose, and duration could not be verified.",
      "missingness": "Trial-specific AE definitions, collection, exposure denominators by arm, duration, and discontinuation materials",
      "uncertainty": "Trial-specific AE definitions, collection, exposure denominators by arm, duration, and discontinuation materials. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Trial-specific AE definitions, collection, exposure denominators by arm, duration, and discontinuation materials"
    },
    {
      "item_id": "N32",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are general B6 neuropathy warnings distinguished from risk estimates in PMS trials?",
      "needed": "Products, combined exposure, populations, duration, and denominators in neuropathy materials, together with PMS safety follow-up",
      "role": "Supplementary; required for extrapolating harms",
      "role_reason": "It has not been verified that official general safety information concerns the same exposure and population as the PMS trials, including their actual doses and durations.",
      "application_exception": "Do not turn reports below 50 mg/day into a threshold below which no harm occurs or a risk estimate covering all low doses.",
      "criterion": "Separate the population, cumulative exposure, and scope of general warnings from the unverified direct PMS harm evidence.",
      "basis": "E10: M19 §19.1.2–19.2.4; custom application / H04: M19 §19.1.2–19.2.4; custom application / H08: M19 §19.1.2–19.2.4; custom application / H09: Chamgap's own interpretation boundary. M19 principles are referenced; no formal causality tool is applied. Reason for applying this to the overall PMS score comparison: it has not been verified that official general safety information concerns the same exposure and population as the PMS trials, including their actual doses and durations. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Review general regulatory and safety-signal materials separately from direct comparative harm materials, and do not calculate new thresholds or risks.",
      "current_reports": [
        "S12",
        "S13",
        "S14",
        "S16"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The retained TGA account records neuropathy reports even below 50 mg/day and warns about cumulative intake and potentially irreversible injury. This does not newly establish the incidence in PMS trials or comparative risk by specific vitamer or product.",
      "condition_status": "Partly verified",
      "status_reason": "General safety context is available, but there is no exposure, denominator, and risk comparison matching the PMS trials.",
      "missingness": "Products, combined exposure, populations, duration, and denominators in neuropathy materials, together with PMS safety follow-up",
      "uncertainty": "Products, combined exposure, populations, duration, and denominators in neuropathy materials, together with PMS safety follow-up. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Products, combined exposure, populations, duration, and denominators in neuropathy materials, together with PMS safety follow-up"
    },
    {
      "item_id": "N33",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the EFSA upper limit and Australia's future regulation distinguished from treatment doses and current regulations?",
      "needed": "The edition, publication/effective dates, and scope of the official documents, together with the original cutoff date",
      "role": "Supplementary; indication of regulatory and safety scope",
      "role_reason": "The upper limit for total nutrient intake and the effective date of sales rules are different facts from PMS treatment efficacy or a threshold below which no harm occurs.",
      "application_exception": "Present this as the record at the original cutoff, without performing a current-law lookup or creating a dose recommendation in this review.",
      "criterion": "The nature of 12 mg/day as an upper limit for total intake and the time boundary of the scheduled effective date, 2027-06-01, are kept distinct.",
      "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction flagging and test adaptations are custom designs / C09: M04 §4.5, §4.6.3; limits on transitioning to current materials are based on the user's scope and custom design / E10: M19 §19.1.2–19.2.4; custom application / H09: Chamgap's own interpretation boundary. M19 principles are referenced; no formal causality tool is applied. Reason for applying this to the overall PMS score comparison: the upper limit for total nutrient intake and the effective date of sales rules are different facts from PMS treatment efficacy or a threshold below which no harm occurs. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Within an authorized update scope, compare document editions and effective dates, and keep them separate from treatment doses and biological thresholds.",
      "current_reports": [
        "S12",
        "S14"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The original cutoff is 2026-09-15. EFSA's adult 12 mg/day is an upper limit for chronic total intake; TGA's pharmacist-only change for above 50 mg~up to 200 mg/day is retained as scheduled to take effect on 2027-06-01. These are not treatment doses or current evidence of efficacy.",
      "condition_status": "Met",
      "status_reason": "Only the meaning and date boundaries of the retained regulatory and safety record were checked. This status does not newly certify current law or individual safety.",
      "missingness": "The edition, publication/effective dates, and scope of the official documents, together with the original cutoff date",
      "uncertainty": "The edition, publication/effective dates, and scope of the official documents, together with the original cutoff date. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "The edition, publication/effective dates, and scope of the official documents, together with the original cutoff date"
    },
    {
      "item_id": "N34",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are statistical magnitude, clinical importance, and other clinical questions kept separate?",
      "needed": "Materials on a validated MCID, importance to patients, and applicability for the overall scale in question",
      "role": "Required",
      "role_reason": "This is needed to avoid turning the conventional magnitude of Hedges g into a validated MCID or a treatment benefit for PMDD or pregnancy.",
      "application_exception": "Do not recalculate the historical g=-0.53 and -0.52559 or C·50, or use them as condition-status scores.",
      "criterion": "Verified clinical importance and applicability for the overall PMS endpoint are distinguished from unresolved details.",
      "basis": "E05: M15 §15.3.1–15.3.3; custom application / E09: M03 §3.2.4; custom limits on extrapolation / E08: M03 §3.2.1–3.2.4; details of dose, duration, and effect modification are custom designs. Reason for applying this to the overall PMS score comparison: this is needed to avoid turning the conventional magnitude of Hedges g into a validated MCID or a treatment benefit for PMDD or pregnancy. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Compare evidence on importance to patients and scale validation against the results, without inventing arbitrary thresholds or success probabilities.",
      "current_reports": [
        "S02",
        "S03"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The historical end-of-treatment Hedges g=-0.53 is a statistical-magnitude classification under the original scoring rubric, not a validated between-group MCID. Clinical importance and sustained benefit remain unverified, and this is not a verdict on PMDD or pregnancy nausea.",
      "condition_status": "Unverified",
      "status_reason": "The statistical value was preserved, but there is no validated clinical-importance criterion for this scale or direct evidence for events or other populations.",
      "missingness": "Materials on a validated MCID, importance to patients, and applicability for the overall scale in question",
      "uncertainty": "Materials on a validated MCID, importance to patients, and applicability for the overall scale in question. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Materials on a validated MCID, importance to patients, and applicability for the overall scale in question"
    },
    {
      "item_id": "N35",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Is actual reading of local summaries distinguished from past access, external materials not read in this review, and the associated dates?",
      "needed": "Records of actual access, acquisition, and reading events, with material-specific dates and original locations",
      "role": "Required",
      "role_reason": "This is needed to avoid treating verified_date or historical access_level as an actual access date for each material in this review or as evidence of full-text reading in this review.",
      "application_exception": "Do not treat a historical failed direct connection as an access failure in this review, or fill in missing date keys arbitrarily.",
      "criterion": "Reading of currently archived summaries, report-specific historical access declarations, blank access dates, the original review date, and external access not attempted in this review are distinguished.",
      "basis": "C03: data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are custom designs / C09: M04 §4.5, §4.6.3; limits on transitioning to current materials are based on the user's scope and custom design. Reason for applying this to the overall PMS score comparison: this is needed to avoid treating verified_date or historical access_level as an actual access date for each material in this review or as evidence of full-text reading in this review. No formal RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "Review access events separately for each material, and add current actions and dates only when new reading is authorized.",
      "current_reports": [
        "S01",
        "S02",
        "S03",
        "S04",
        "S05",
        "S06",
        "S07",
        "S08",
        "S09",
        "S10",
        "S11",
        "S12",
        "S13",
        "S14",
        "S15",
        "S16",
        "S17",
        "S18",
        "S19",
        "S20",
        "S21"
      ],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "This review read the currently retained KO/EN manuscripts, 9 evidence entries, 21 bibliographic entries, and metadata. The original verified_date is 2026-09-15, and there is no actual-access-date key for each citation. Each material's access date is blank; the original review date is separate. External originals, separate indexes/ZIP files, and 127 were not read in this review.",
      "condition_status": "Met",
      "status_reason": "This condition records the boundary between actual local actions and historical declarations. It does not directly certify the current contents of external materials.",
      "missingness": "Records of actual access, acquisition, and reading events, with material-specific dates and original locations",
      "uncertainty": "Records of actual access, acquisition, and reading events, with material-specific dates and original locations. Scope is limited to the currently retained records; no new judgment is made about clinical efficacy, an individual's probability of success, or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Records of actual access, acquisition, and reading events, with material-specific dates and original locations"
    },
    {
      "item_id": "N36",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are the original C·50 assessment and the different verdict and policy of historical composite record 127 kept separate from current condition statuses?",
      "needed": "Current judgment, relationships to related records, original axes and version metadata",
      "role": "Required",
      "role_reason": "Preserving the original judgment does not issue an efficacy score or a checklist fulfillment rate for the new table.",
      "application_exception": "From 127, do not repurpose the B·60 judgment or pregnancy-nausea evidence, and do not open the original 127 file in this task.",
      "criterion": "Preserve the original C·50, axes, related document quality and historical relationship to 127, without repurposing grades/axes/scores for new judgments.",
      "basis": "C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are self-designed / C09: M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user-defined scope and self-designed rules. Reason for applying this to the overall PMS score comparison: Preserving the original judgment does not issue an efficacy score or a checklist fulfillment rate for the new table. No official RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "When making a correction, preserve the original event, before-and-after values and version, and distinguish revision of the conditions from a change in the clinical judgment as separate tasks.",
      "current_reports": [],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "The judgment in the current manuscript is C·50, with axes B/P/R1/I1/E+/B2/CX. The combined PMS/pregnancy-nausea record in 127 and its B·60 are related history and have not been repurposed for the current PMS-only claim. Preserve the numbers and original metadata of the current original judgment unchanged.",
      "condition_status": "Met",
      "status_reason": "The separation of current/historical judgments and the rule that they remain unchanged were verified. C·50 is not used as evidence that individual conditions are met.",
      "missingness": "Current judgment, relationships to related records, original axes and version metadata",
      "uncertainty": "Current judgment, relationships to related records, original axes and version metadata: this is the scope of the currently preserved record, without a new judgment of clinical efficacy, individual probability of success or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Current judgment, relationships to related records, original axes and version metadata"
    },
    {
      "item_id": "N37",
      "question_type": "Comparison of overall PMS symptoms",
      "question": "Are statements of insufficiency or uncertainty linked to the scope of preservation, reference date and conditions for updating?",
      "needed": "Dates, the actual preserved records of search/selection/calculation, and the original location of each update event",
      "role": "Required",
      "role_reason": "This is needed to avoid overstating gaps in the current summary as absence of research worldwide, an effect of 0, or a current comprehensive search.",
      "application_exception": "Do not label search, selection or calculation files in the old ZIP as materials actually read in this task.",
      "criterion": "Record the original reference date, the date of the current review, the scope of what remains unverified and specific update events.",
      "basis": "C09: M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user-defined scope and self-designed rules / E06: M08 Table 8.2.a, M04 §4.6.3; self-designed application. Reason for applying this to the overall PMS score comparison: This is needed to avoid overstating gaps in the current summary as absence of research worldwide, an effect of 0, or a current comprehensive search. No official RoB2/GRADE assessment or clinical certification was performed.",
      "condition_origin": "Before application, the self-designed conditions for a development case that had already been read are frozen by a separate, actually executed command. This is not automatic copying, blinding, clinical preregistration, or methodological certification.",
      "proposed_research": "When new materials are permitted and become available, compare their identity, scope and version, and review only the observations and status of the relevant conditions again.",
      "current_reports": [],
      "existence": "Limited to checking the currently retained manuscript/structure, bibliographic information, and history.",
      "acquired_read": "Summary reading: the specified original locations in the currently archived source summary were actually read. External originals and old separate copies were not read in this review.",
      "observation": "Record from the preservation-table review dated 2026-10-05: The original evidence reference date is 2026-09-15, and the review date for that work was 2026-10-05. Update conditions include dose, vitamer, hierarchy, scale, denominators, intervals, corrections, safety and recovery of the original location for the 80 mg/day record. The existing ZIP/calculation records were references only; no new search or effect calculation was performed.",
      "condition_status": "Met",
      "status_reason": "The record of the scope verified and the update conditions was checked. This does not certify the completeness of the literature or the presence or absence of an effect.",
      "missingness": "Dates, the actual preserved records of search/selection/calculation, and the original location of each update event",
      "uncertainty": "Dates, the actual preserved records of search/selection/calculation, and the original location of each update event: this is the scope of the currently preserved record, without a new judgment of clinical efficacy, individual probability of success or safety.",
      "review_date": "2026-10-05",
      "reading_status": "Original not read · Archived summary read",
      "additional_material": "Dates, the actual preserved records of search/selection/calculation, and the original location of each update event"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Wyatt et al. 1999. Efficacy of vitamin B-6 in the treatment of premenstrual syndrome: systematic review",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC27878/",
      "report_type": "Full HTML text of the original review article",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: This is an older review with mixed interventions and endpoints. It is not counted as a new independent trial.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the original review article",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. This is an older review with mixed interventions and endpoints. It is not counted as a new independent trial. Original location: Abstract; Table 1; vitamin B6 alone subgroup; Discussion. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S01-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC27878/",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC27878/"
        }
      ]
    },
    {
      "report_id": "S02",
      "title": "Ebrahimi et al. 2012. Effects of Magnesium and Vitamin B6 on the Severity of Premenstrual Syndrome Symptoms",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4161081/",
      "report_type": "PMC link to the original article (distinct from the historical indexed extract)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-EBRA",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: The full text was read through a search index, and direct repeat access was blocked. B6 dose unverified; 250 mg refers to magnesium. Actual comparison/role: Separate magnesium, B6-only and placebo arms; B6 dose not reported. Denominator: Allocated 42 per group; completed B6 36 and placebo 37; endpoint denominator unverified. Endpoint: Overall score from a separate 30-symptom diary; a different scale from the main trial. Result: B6 36.51→22.84, placebo 35.80→28.41; arithmetic change contrast -6.28 points; between-group change CI unverified. Funding: Coded tablets supplied by the university pharmacy verified; funding and author COI unverified. Limitations: Supportive evidence; not pooled with a different scale. Allocated 42 per group; completed B6 36/placebo 37; endpoint analysis denominator unverified. 250 mg refers to magnesium, and the B6 dose was not reported. The historical arithmetic -6.28 points is not pooled with the main 12-symptom scale.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PMC link to the original article (distinct from the historical indexed extract)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: indexed_full_text. The full text was read through a search index, and direct repeat access was blocked. B6 dose unverified; 250 mg refers to magnesium. Original location: Methods; Results; Table 1; article registration header. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S02-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4161081/",
          "parent_url": null
        },
        {
          "material_type": "Indexed full-text extract at the time of preservation (separate copy not read in this task)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: indexed_full_text. Contextual level recorded for the containing document: indexed_full_text. The full text was read through a search index, and direct repeat access was blocked. B6 dose unverified; 250 mg refers to magnesium. Original location: Methods; Results; Table 1; article registration header. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S02-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4161081/"
        }
      ]
    },
    {
      "report_id": "S03",
      "title": "Ghazanfarpour et al. 2017. Hypericum perforutum and Vitamin B6 as a Treatment for Premenstrual Syndrome",
      "url": "https://brieflands.com/journals/jjnpp/articles/55301",
      "report_type": "Full HTML text of the original article on the publisher site",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-GHAZ",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Records of HTML/PDF acquisition and visual table checking were reused. B6 is a separate arm from Hypericum. Actual comparison/role: Parallel B6-only, Hypericum and placebo arms; only B6 and placebo are used for this effect. Denominator: Table analysis headers B6 78 and placebo 78; overall recruitment/allocation descriptions conflict. Endpoint: Overall total of the 12-symptom diary; lower is better; total-score normalization unverified. Result: Baseline→end B6 33.93→20.92, placebo 33.86→23.90; arithmetic change contrast -3.05 points; formal change-contrast CI unverified. Funding: Specific funding and B6 product supplier unverified; the authors’ no-conflict declaration is separate from proof of independent funding. Limitations: Main evidence; limitations in bias and measurement reporting. The preserved table has B6 33.93(SD 6.95)→20.92(SD 5.26), placebo 33.86(SD 6.16)→23.90(SD 6.00), with 78 per group. The historical arithmetic change contrast -3.05 points, end-of-treatment difference -2.98 points and end-of-treatment Hedges g=-0.53 are not an official adjusted change contrast or MCID. The original test P, detailed participant counts and tablet-strength wording are absent from the currently archived summary.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the original article on the publisher site",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. Records of HTML/PDF acquisition and visual table checking were reused. B6 is a separate arm from Hypericum. Original location: PDF pp.1–3: Methods, Results, Table 1 Total row and footnote, Table 2; p.5 Footnotes/ref.8. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S03-M1",
          "url": "https://brieflands.com/journals/jjnpp/articles/55301",
          "parent_url": null
        },
        {
          "material_type": "Full PDF of the original article (exact PDF URL currently unverified)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. Records of HTML/PDF acquisition and visual table checking were reused. B6 is a separate arm from Hypericum. Original location: PDF pp.1–3: Methods, Results, Table 1 Total row and footnote, Table 2; p.5 Footnotes/ref.8. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S03-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://brieflands.com/journals/jjnpp/articles/55301"
        }
      ]
    },
    {
      "report_id": "S04",
      "title": "Doll, Brown, Thurston and Vessey 1989. Pyridoxine (vitamin B6) and the premenstrual syndrome: a randomized crossover trial",
      "url": "https://pubmed.ncbi.nlm.nih.gov/2558186/",
      "report_type": "PubMed abstract",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-DOLL",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Abstract-level access. The original overall-score tables and paired variance could not be verified. Actual comparison/role: Pyridoxine 50 mg/day versus placebo; crossover design. Denominator: 63 entered; the full 7 months were completed by 32 participants; endpoint-specific denominators unverified. Endpoint: A 9-symptom diary; distinguish the emotional-domain signal from overall PMS. Result: The emotional-subdomain result is not repurposed as overall symptom improvement. Funding: Funding and COI unverified in the accessed abstract. Limitations: Qualitative evidence with a limited scope.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed abstract",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: abstract. Contextual level recorded for the containing document: abstract. Abstract-level access. The original overall-score tables and paired variance could not be verified. Original location: Abstract: design, entry/completion, emotional-symptom findings. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S04-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/2558186/",
          "parent_url": null
        },
        {
          "material_type": "Full text of the original article (exact URL and historical full-text access currently unverified)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: abstract. Abstract-level access. The original overall-score tables and paired variance could not be verified. Original location: Abstract: design, entry/completion, emotional-symptom findings. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S04-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/2558186/"
        }
      ]
    },
    {
      "report_id": "S05",
      "title": "Kendall and Schnurr 1987. The effects of vitamin B6 supplementation on premenstrual symptoms",
      "url": "https://pubmed.ncbi.nlm.nih.gov/3299182/",
      "report_type": "PubMed bibliographic/abstract link (distinct from the historical index)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-KENDALL",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Indexed abstract and secondary (2nd) extraction from reviews. The original overall-score mean is unverified. Actual comparison/role: Pyridoxine 150 mg/day versus placebo. Denominator: Review record of 55 completers; original endpoint denominator unverified. Endpoint: Mixed subdomains; original overall-score mean unverified. Result: The overall symptom mean and confidence interval could not be verified. Funding: Unverified; independence of the study is not assumed. Limitations: Secondary (2nd) extraction and limited qualitative material.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed bibliographic/abstract link (distinct from the historical index)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: indexed_abstract. Indexed abstract and secondary (2nd) extraction from reviews. The original overall-score mean is unverified. Original location: Indexed abstract; S01 Table 1 and S10 Table 1 for secondary details. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S05-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/3299182/",
          "parent_url": null
        },
        {
          "material_type": "Indexed abstract/review extract at the time of preservation (separate copy not read in this task)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: indexed_abstract. Contextual level recorded for the containing document: indexed_abstract. Indexed abstract and secondary (2nd) extraction from reviews. The original overall-score mean is unverified. Original location: Indexed abstract; S01 Table 1 and S10 Table 1 for secondary details. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S05-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/3299182/"
        }
      ]
    },
    {
      "report_id": "S06",
      "title": "Kashanian et al. 2007. Pyridoxine (vitamin B6) therapy for premenstrual syndrome",
      "url": "https://pubmed.ncbi.nlm.nih.gov/17187801/",
      "report_type": "PubMed bibliographic link (original result location not recovered)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-KASH",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Metadata-access records are distinguished from the numbers in the request to resume the work. The 80 mg/day, -1.80 versus -0.93, and an initial 160 with 94 analysed were preserved but not used for grading because the original result location and dispersion were not recovered. Actual comparison/role: Preserved record of pyridoxine 80 mg/day versus placebo; salt and exact formulation unverified. Denominator: Preserved record of an initial 160 with 94 analysed; stage-specific and per-arm denominators unverified. Endpoint: Values carried as overall PMS change; exact scale and original text location not recovered. Result: -1.80 versus -0.93 preserved, arithmetic difference -0.87; no SD/CI/p values invented. Funding: Funding, product supply and COI unverified; an author was added by correction in 2020. Limitations: Preservation of carried values only; not used for new original-source verification, grading or independent replication. The 80 mg/day, B6 -1.80 versus placebo -0.93, initial 160 with 94 analysed, and historical arithmetic -0.87 points are values carried in the request to resume the work. Per-arm denominators/dispersion/original Results location were not recovered, so these were not used as new verification, for grading or as replication.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed bibliographic link (original result location not recovered)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: metadata. Contextual level recorded for the containing document: metadata. Metadata-access records are distinguished from the numbers in the request to resume the work. The 80 mg/day, -1.80 versus -0.93, and initial 160 with 94 analysed were preserved but not used for grading because the original result location and dispersion were not recovered. Original location: Bibliographic record; secondary trial description in review literature. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S06-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/17187801/",
          "parent_url": null
        },
        {
          "material_type": "Full text of the original article (exact original Results location and historical full-text access unverified)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: metadata. Metadata-access records are distinguished from the numbers in the request to resume the work. The 80 mg/day, -1.80 versus -0.93, and initial 160 with 94 analysed were preserved but not used for grading because the original result location and dispersion were not recovered. Original location: Bibliographic record; secondary trial description in review literature. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S06-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/17187801/"
        }
      ]
    },
    {
      "report_id": "S07",
      "title": "Kashanian et al. 2020. Corrigendum to Pyridoxine (vitamin B6) therapy for premenstrual syndrome",
      "url": "https://obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.13157",
      "report_type": "Link to the correction adding an author",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-KASH",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: This is a correction adding an author in 2020. It was not described as a numerical correction or a retraction.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Link to the correction adding an author",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. This is a correction adding an author in 2020. It was not described as a numerical correction or a retraction. Original location: Corrigendum text and corrected author list. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S07-M1",
          "url": "https://obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.13157",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.13157"
        }
      ]
    },
    {
      "report_id": "S08",
      "title": "Retallick-Brown, Blampied and Rucklidge 2020. A Pilot Randomized Treatment-Controlled Trial Comparing Vitamin B6 with Broad-Spectrum Micronutrients for Premenstrual Syndrome",
      "url": "https://pubmed.ncbi.nlm.nih.gov/31928364/",
      "report_type": "PubMed bibliographic link (active comparator/composition cross-checked in a review)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-RET",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: This used an active comparator, and the review describes inclusion of riboflavin. It is not a strict B6-only versus placebo comparison. Actual comparison/role: Broad-spectrum micronutrients versus a B6 comparator; the review also describes riboflavin. Denominator: Not used as a denominator for the present B6-only versus placebo effect. Endpoint: Do not mix modified DRSP with other scales or comparison specifications. Result: Excluded from the direct effect because there was no placebo and the strict monotherapy condition was not met. Funding: Original funding and COI unverified; no additional credit for independence. Limitations: Excluded evidence.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed bibliographic link (active comparator/composition cross-checked in a review)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: metadata. Contextual level recorded for the containing document: metadata. This used an active comparator, and the review describes inclusion of riboflavin. It is not a strict B6-only versus placebo comparison. Original location: Bibliographic record; design and composition cross-checked in S10 Table 1. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S08-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/31928364/",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/31928364/"
        }
      ]
    },
    {
      "report_id": "S09",
      "title": "De Souza et al. 2000. Magnesium plus vitamin B6 and anxiety-related premenstrual symptoms",
      "url": "https://pubmed.ncbi.nlm.nih.gov/10746516/",
      "report_type": "PubMed bibliographic link (combination-intervention anxiety result)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-DESOUZA",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: The anxiety subdomain result for a combination intervention is not the overall PMS effect of B6 alone. Possible report overlap was handled conservatively. Actual comparison/role: Distinguish magnesium, B6, combination and placebo crossover data. Denominator: Not counted as a new denominator for the present overall-severity effect. Endpoint: The anxiety subdomain and overall severity are separate. Result: Do not repurpose the combination-intervention anxiety result as overall symptoms with B6 alone. Funding: Unverified. Limitations: Limited scope; excluded from the direct effect.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PubMed bibliographic link (combination-intervention anxiety result)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: metadata. Contextual level recorded for the containing document: metadata. The anxiety subdomain result for a combination intervention is not the overall PMS effect of B6 alone. Possible report overlap was handled conservatively. Original location: Bibliographic record; S01 and S10 trial tables for related crossover material. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S09-M1",
          "url": "https://pubmed.ncbi.nlm.nih.gov/10746516/",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pubmed.ncbi.nlm.nih.gov/10746516/"
        }
      ]
    },
    {
      "report_id": "S10",
      "title": "Robinson et al. 2025 (online 2024). Effect of nutritional interventions on the psychological symptoms of premenstrual syndrome in women of reproductive age: a systematic review of randomized controlled trials",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11723155/",
      "report_type": "Full HTML text of the original review article",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Used for identifying updates and cross-checking. Psychological symptoms and overall symptom severity are different endpoints.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full HTML text of the original review article",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. Used for identifying updates and cross-checking. Psychological symptoms and overall symptom severity are different endpoints. Original location: Table 1, vitamin B6 rows; discussion and risk-of-bias sections. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S10-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11723155/",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11723155/"
        }
      ]
    },
    {
      "report_id": "S11",
      "title": "Ghazanfarpour et al. 2011. Hypericum perforatum for the treatment of premenstrual syndrome",
      "url": "https://doi.org/10.1016/j.ijgo.2010.11.007",
      "report_type": "DOI bibliographic link (original full text not historically acquired)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-GHAZ",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Explicitly identified as an earlier partial report of S03, so it belongs to the same trial family. The original full text was not acquired.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "DOI bibliographic link (original full text not historically acquired)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: metadata. Explicitly identified as an earlier partial report of S03, so it belongs to the same trial family. The original full text was not acquired. Original location: S03 Methods statement and reference 8. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S11-M1",
          "url": "https://doi.org/10.1016/j.ijgo.2010.11.007",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://doi.org/10.1016/j.ijgo.2010.11.007"
        }
      ]
    },
    {
      "report_id": "S12",
      "title": "TGA 2026. Medicines containing vitamin B6 (pyridoxine, pyridoxal or pyridoxamine)",
      "url": "https://www.tga.gov.au/news/safety-updates/medicines-containing-vitamin-b6-pyridoxine-pyridoxal-or-pyridoxamine",
      "report_type": "Full text of the official TGA webpage",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: The change to pharmacist-only status for above 50 mg~up to 200 mg/day was scheduled to take effect on 2027-06-01 and was not treated as a regulation in force at the reference date.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full text of the official TGA webpage",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. The change to pharmacist-only status for above 50 mg~up to 200 mg/day was scheduled to take effect on 2027-06-01 and was not treated as a regulation in force at the reference date. Original location: Published 19 February 2026, updated 7 April 2026; scheduling and neuropathy sections. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S12-M1",
          "url": "https://www.tga.gov.au/news/safety-updates/medicines-containing-vitamin-b6-pyridoxine-pyridoxal-or-pyridoxamine",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.tga.gov.au/news/safety-updates/medicines-containing-vitamin-b6-pyridoxine-pyridoxal-or-pyridoxamine"
        }
      ]
    },
    {
      "report_id": "S13",
      "title": "TGA 2026. Are you unknowingly taking too much vitamin B6?",
      "url": "https://www.tga.gov.au/news/blog/are-you-unknowingly-taking-too-much-vitamin-b6",
      "report_type": "Full text of the official TGA webpage",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Official safety information on neuropathy and cumulative intake, not PMS efficacy evidence.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full text of the official TGA webpage",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. Official safety information on neuropathy and cumulative intake, not PMS efficacy evidence. Original location: 4 March 2026; peripheral neuropathy, cumulative intake, irreversible injury and stopping advice. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S13-M1",
          "url": "https://www.tga.gov.au/news/blog/are-you-unknowingly-taking-too-much-vitamin-b6",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.tga.gov.au/news/blog/are-you-unknowingly-taking-too-much-vitamin-b6"
        }
      ]
    },
    {
      "report_id": "S14",
      "title": "EFSA 2023. Scientific opinion on the tolerable upper intake level for vitamin B6",
      "url": "https://www.efsa.europa.eu/en/efsajournal/pub/8006",
      "report_type": "EFSA official literature link (distinct from the linked Wiley full text)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: The upper intake level of 12 mg/day in the officially linked full text concerns chronic total intake, not a treatment dose.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "EFSA official literature link (distinct from the linked Wiley full text)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: full_text. The upper intake level of 12 mg/day in the officially linked full text concerns chronic total intake, not a treatment dose. Original location: Abstract; Conclusions, adult UL derivation. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S14-M1",
          "url": "https://www.efsa.europa.eu/en/efsajournal/pub/8006",
          "parent_url": null
        },
        {
          "material_type": "Linked original Wiley full text (exact URL currently unverified)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. The upper intake level of 12 mg/day in the officially linked full text concerns chronic total intake, not a treatment dose. Original location: Abstract; Conclusions, adult UL derivation. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S14-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.efsa.europa.eu/en/efsajournal/pub/8006"
        }
      ]
    },
    {
      "report_id": "S15",
      "title": "NIH ODS. Vitamin B6: Fact Sheet for Health Professionals",
      "url": "https://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/",
      "report_type": "NIH official full-webpage link (distinct from historical index/print access)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Direct-request errors occurred, so only content accessed through an index or print view was used. It does not establish the salt used in the trial.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "NIH official full-webpage link (distinct from historical index/print access)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: indexed_text. Direct-request errors occurred, so only content accessed through an index or print view was used. It does not establish the salt used in the trial. Original location: Vitamin forms; Recommended Intakes; Health Risks from Excessive Vitamin B6. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S15-M1",
          "url": "https://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/",
          "parent_url": null
        },
        {
          "material_type": "Indexed/print content at the time of preservation (separate copy not read in this task)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: indexed_text. Contextual level recorded for the containing document: indexed_text. Direct-request errors occurred, so only content accessed through an index or print view was used. It does not establish the salt used in the trial. Original location: Vitamin forms; Recommended Intakes; Health Risks from Excessive Vitamin B6. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read. The direct URL of this physical material is not preserved. A bibliographic link is not substituted for a direct file URL.",
          "material_id": "S15-M2",
          "url": null,
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/"
        }
      ]
    },
    {
      "report_id": "S16",
      "title": "MedlinePlus. Pyridoxine drug information",
      "url": "https://medlineplus.gov/druginfo/meds/a682587.html",
      "report_type": "Full text of the official MedlinePlus webpage",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Used to check medicines, supplements and special populations; no PMS efficacy recommendation was imported.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Full text of the official MedlinePlus webpage",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: full_text. Contextual level recorded for the containing document: full_text. Used to check medicines, supplements and special populations; no PMS efficacy recommendation was imported. Original location: Special precautions; side effects; revised 15 August 2017. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S16-M1",
          "url": "https://medlineplus.gov/druginfo/meds/a682587.html",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://medlineplus.gov/druginfo/meds/a682587.html"
        }
      ]
    },
    {
      "report_id": "S17",
      "title": "ACOG 2023. Management of Premenstrual Disorders, Clinical Practice Guideline No. 7",
      "url": "https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2023/12/management-of-premenstrual-disorders",
      "report_type": "ACOG guideline literature link (historical full-text access failed)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "Review, safety and informational documents not classified as trial families",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Full-text access to the guideline failed. Its recommendations were not used for efficacy grading. It is separate from pregnancy-nausea guidance.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "ACOG guideline literature link (historical full-text access failed)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: access_failed. Contextual level recorded for the containing document: access_failed. Full-text access to the guideline failed. Its recommendations were not used for efficacy grading. It is separate from pregnancy-nausea guidance. Original location: Bibliographic identity and official URL only. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S17-M1",
          "url": "https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2023/12/management-of-premenstrual-disorders",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2023/12/management-of-premenstrual-disorders"
        }
      ]
    },
    {
      "report_id": "S18",
      "title": "IRCT201106216854N1 registration pointer",
      "url": "https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT201106216854N1",
      "report_type": "WHO registration-record link (detailed history unverified)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-EBRA",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: The registration identifier appears in the original article, but registry details, history and whether registration was prospective could not be verified.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "WHO registration-record link (detailed history unverified)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: access_failed. Contextual level recorded for the containing document: access_failed. The registration identifier appears in the original article, but registry details, history and whether registration was prospective could not be verified. Original location: Registration number in S02 article header. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S18-M1",
          "url": "https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT201106216854N1",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT201106216854N1"
        }
      ]
    },
    {
      "report_id": "S19",
      "title": "Fathizadeh et al. 2010. Evaluating the effect of magnesium and magnesium plus vitamin B6 supplement on the severity of premenstrual syndrome",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3208934/",
      "report_type": "PMC original-article link (historical verification was indexed bibliographic information)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-FATH",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Excluded because this was a combination trial. Possible overlap with S02 is unverified, and it was not counted as independent replication. Actual comparison/role: Comparisons such as magnesium versus magnesium+B6. Denominator: Not added as participants in an independent B6-only replication. Endpoint: Not an overall effect of B6 alone. Result: Excluded from the direct effect because this was a combination intervention. Funding: Unverified. Limitations: Excluded; overlap with S02 unverified.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "PMC original-article link (historical verification was indexed bibliographic information)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: metadata. Excluded because this was a combination trial. Possible overlap with S02 is unverified, and it was not counted as independent replication. Original location: Indexed title/metadata and related trial discussion. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S19-M1",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3208934/",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3208934/"
        }
      ]
    },
    {
      "report_id": "S20",
      "title": "2025. Comparison of the Effects of Vitagnus, Soy, and Vitagnus-soy Capsules on the Severity of Premenstrual Syndrome",
      "url": "https://ijcbnm.sums.ac.ir/article_50585_7dd12040edca4d010200928714a1ba05.pdf",
      "report_type": "Original-article PDF link (historical verification was the p.1 abstract section)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-VITAGNUS",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Excluded as a false-positive search result with no B6 intervention. Actual comparison/role: Vitagnus, soy and combination; no B6 arm. Denominator: Not counted as participants for a B6 effect. Endpoint: Not applicable to the present B6 endpoint. Result: Excluded as a wrong-intervention search result. Funding: No separate funding extraction was performed for this excluded study. Limitations: Excluded.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "Original-article PDF link (historical verification was the p.1 abstract section)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: Unverified. Contextual level recorded for the containing document: full_text. Excluded as a false-positive search result with no B6 intervention. Original location: PDF p.1 abstract visually checked. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S20-M1",
          "url": "https://ijcbnm.sums.ac.ir/article_50585_7dd12040edca4d010200928714a1ba05.pdf",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://ijcbnm.sums.ac.ir/article_50585_7dd12040edca4d010200928714a1ba05.pdf"
        }
      ]
    },
    {
      "report_id": "S21",
      "title": "Retallick-Brown et al. 2016. Micronutrients for premenstrual symptoms: study protocol",
      "url": "https://www.mdpi.com/2305-6320/3/4/32",
      "report_type": "MDPI protocol link (historical direct 429 response/indexed information)",
      "existence": "This refers to archived bibliographic information and historical records; the current external response has not been verified.",
      "acquired_read": "The corresponding Korean and English summaries and bibliographic records in the archived manuscript were read. The linked external original materials have not been read in this task.",
      "study_family": "TF-RET",
      "independent_replication": "Link the original evidence families and explicitly stated same-trial/protocol relationships. Do not assign clinical trial families to reviews or general documents. Registry details and overlap between S19/S02 remain unverified.",
      "observed_result": "Record at the time of preservation: Access was restricted, and this was grouped as the protocol for S08. It is not a separate trial or effect.",
      "result_level": "This is content recorded in the archived manuscript, not the result of a new comparison with the current external original materials.",
      "source_evidence_date": "2026-09-15",
      "materials": [
        {
          "material_type": "MDPI protocol link (historical direct 429 response/indexed information)",
          "public_status": "Currently unverified",
          "access_status": "Not attempted this time",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-11-01",
          "qualification": "The historical access date of each material is unverified. The archived manuscript’s review date, 2026-09-15, is not this file’s access date. Historical access level recorded for this physical material: access_failed. Contextual level recorded for the containing document: access_failed. Access was restricted, and this was grouped as the protocol for S08. It is not a separate trial or effect. Original location: Indexed protocol information only. The historical access level is recorded only when access to this physical material is explicitly stated in the source. Access to separate links, original full texts, indexed/print extracts or the whole PDF is not automatically inherited from the containing document’s access level. The archived summary was read in this task; the external material was not attempted, acquired or read.",
          "material_id": "S21-M1",
          "url": "https://www.mdpi.com/2305-6320/3/4/32",
          "parent_url": null
        }
      ],
      "links": [
        {
          "label": "Source",
          "url": "https://www.mdpi.com/2305-6320/3/4/32"
        }
      ]
    }
  ],
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations of the intervention.",
      "review_level": "Historical reuse, from 1585, of the original-byte/SHA inspection copies and principles of the 5 methodological HTML documents. This is not a new reading of the full methods texts or an official assessment/certification."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because a result was not reported.",
      "review_level": "Historical reuse, from 1585, of the original-byte/SHA inspection copies and principles of the 5 methodological HTML documents. This is not a new reading of the full methods texts or an official assessment/certification."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Fix the outcome and effect of interest when reviewing randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Historical reuse, from 1585, of the original-byte/SHA inspection copies and principles of the 5 methodological HTML documents. This is not a new reading of the full methods texts or an official assessment/certification."
    },
    {
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      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Historical reuse, from 1585, of the original-byte/SHA inspection copies and principles of the 5 methodological HTML documents. This is not a new reading of the full methods texts or an official assessment/certification."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.",
      "review_level": "Historical reuse, from 1585, of the original-byte/SHA inspection copies and principles of the 5 methodological HTML documents. This is not a new reading of the full methods texts or an official assessment/certification."
    }
  ],
  "status_dictionary": {
    "Met": "The specific narrow condition concerning identity, attribution of numbers, records or interpretive boundaries is met. This does not certify a clinical effect, absence of risk or current verification of external full texts.",
    "Partly verified": "Some substantive content is available, but verification of the question’s product, diagnosis, denominators, analysis/materials is incomplete.",
    "Unverified": "Cannot be established within the currently preserved scope. This does not mean an effect of 0, absence of research worldwide or an access failure in this task.",
    "Conflicting records": "Inconsistent reports of the same fact remain. Successful preservation of a conflict is distinguished from verification of actual consistency.",
    "Not reported": "Not reported only within the explicitly identified content obtained at that time. Do not extend this to the entire full text that has not been read in this task.",
    "Not applicable": "Use only when there is a reason the condition does not apply to the current claim. This is not a substitute for unverified or unread.",
    "Inaccessible": "Distinguish an actual failure in this task from a historical failure. Do not assign this to external materials not attempted in this task.",
    "Review incomplete": "Limited to the fact that current external comparison has not been performed. This does not mean that reading of the local archived summaries or individual judgments actually completed is incomplete."
  },
  "study_overlap": {
    "state": "The 21 reports do not mean 21 independent trials. S03/S11 and S08/S21 each belong to the same family, while overlap between S19/S02 is unverified. The current counts of eligible unique trials, participants and independent replications were not newly calculated. TF-GHAZ (S03, S11): Parallel B6-only, Hypericum and placebo arms; only B6 and placebo are used for this effect · Main evidence; limitations in bias and measurement reporting / TF-EBRA (S02, S18): Separate magnesium, B6-only and placebo arms; B6 dose not reported · Supportive evidence; not pooled with a different scale / TF-DOLL (S04): Pyridoxine 50 mg/day versus placebo; crossover design · Qualitative evidence with a limited scope / TF-KENDALL (S05): Pyridoxine 150 mg/day versus placebo · Secondary (2nd) extraction and limited qualitative material / TF-KASH (S06, S07): Preserved record of pyridoxine 80 mg/day versus placebo; salt and exact formulation unverified · Preservation of carried values only; not used for new original-source verification, grading or independent replication / TF-RET (S08, S21): Broad-spectrum micronutrients versus a B6 comparator; the review also describes riboflavin · Excluded evidence / TF-DESOUZA (S09): Distinguish magnesium, B6, combination and placebo crossover data · Limited scope; excluded from the direct effect / TF-FATH (S19): Comparisons such as magnesium versus magnesium+B6 · Excluded; overlap with S02 unverified / TF-VITAGNUS (S20): Vitagnus, soy and combination; no B6 arm · Excluded",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The 21 reports do not mean 21 independent trials. S03/S11 and S08/S21 each belong to the same family, while overlap between S19/S02 is unverified. The current counts of eligible unique trials, participants and independent replications were not newly calculated. TF-GHAZ (S03, S11): Parallel B6-only, Hypericum and placebo arms; only B6 and placebo are used for this effect · Main evidence; limitations in bias and measurement reporting / TF-EBRA (S02, S18): Separate magnesium, B6-only and placebo arms; B6 dose not reported · Supportive evidence; not pooled with a different scale / TF-DOLL (S04): Pyridoxine 50 mg/day versus placebo; crossover design · Qualitative evidence with a limited scope / TF-KENDALL (S05): Pyridoxine 150 mg/day versus placebo · Secondary (2nd) extraction and limited qualitative material / TF-KASH (S06, S07): Preserved record of pyridoxine 80 mg/day versus placebo; salt and exact formulation unverified · Preservation of carried values only; not used for new original-source verification, grading or independent replication / TF-RET (S08, S21): Broad-spectrum micronutrients versus a B6 comparator; the review also describes riboflavin · Excluded evidence / TF-DESOUZA (S09): Distinguish magnesium, B6, combination and placebo crossover data · Limited scope; excluded from the direct effect / TF-FATH (S19): Comparisons such as magnesium versus magnesium+B6 · Excluded; overlap with S02 unverified / TF-VITAGNUS (S20): Vitagnus, soy and combination; no B6 arm · Excluded"
  },
  "history": [
    {
      "date": "2026-11-01",
      "kind": "Public view/material separation",
      "view_version": "1.0",
      "change": "The public view and materials were prepared from the existing 37 items. No new clinical search, change in verification status or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-11-01"
}