{ "title": "Oral vitamin B6-only tablets (exact vitamer and salt unverified in the main trial) × Reduction of overall symptom severity in diagnosed PMS", "criteria_version": "NGM-v3095-B6-MONOTHERAPY-PMS-GLOBAL-SEVERITY-1.0", "criteria_date": "2026-10-05", "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." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Historical reuse, 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." }, "schema_version": "chamgap-public-criteria-1.0", "condition_origin": "Chamgap’s own application conditions", "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ], "language": "en", "translation_date": "2026-11-01" }