{ "schema_version": "chamgap-public-criteria-1.0", "title": "Riboflavin (vitamin B2) × 161.3-km race finishing time in experienced adult ultramarathon runners", "criteria_version": "v3124-B2-ULTRA-FINISH-1.0", "criteria_date": "2026-10-04", "condition_origin": "Chamgap application criteria", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Self-developed application reusing the directly reviewed methodological principles/versions and actual HTML copies/SHAs from 1585. No new reading of full methodological texts or official execution/certification in this work" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Self-developed application reusing the directly reviewed methodological principles/versions and actual HTML copies/SHAs from 1585. No new reading of full methodological texts or official execution/certification in this work" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Self-developed application reusing the directly reviewed methodological principles/versions and actual HTML copies/SHAs from 1585. No new reading of full methodological texts or official execution/certification in this work" }, { "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": "Self-developed application reusing the directly reviewed methodological principles/versions and actual HTML copies/SHAs from 1585. No new reading of full methodological texts or official execution/certification in this work" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Self-developed application reusing the directly reviewed methodological principles/versions and actual HTML copies/SHAs from 1585. No new reading of full methodological texts or official execution/certification in this work" } ], "status_dictionary": { "Met": "The selected preservation/linkage condition can be explained. Distinct from confirmation of efficacy", "Partly verified": "Some required information is linked, but specific gaps remain", "Unverified": "Required information/conditions could not be verified within the currently permitted retained-material review scope", "Conflicting information": "Unresolved conflict among original text/table/total records concerning the same medication-user count. No arbitrary correction", "Not applicable": "Nonapplicability of an extension question absent from the original claim. Distinct from nonreading or absence of effect" }, "requirements": [ { "item_id": "N01", "question_type": "Claim and independent scope", "question": "Which population, intervention, distance and time comparison does this table address?", "needed": "Linkage of the current claim, population, formulation/route, comparator and endpoint to the excluded endpoints on the same page", "role": "Required", "role_reason": "Prevents favorable recovery or nutritional-status results from being transferred to efficacy for finishing time.", "application_exception": "Pain, 400 m recovery, CK and laboratory time to exhaustion are preserved but do not replace this table's time outcome.", "criterion": "Link the original /ko/effect precisely to the single-race finishing-time question and explain whether parent and subordinate claims overlap.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "In subsequent research, prespecify the finishing-time question for the same distance separately from the recovery question." }, { "item_id": "N02", "question_type": "Ingredient and product identity", "question": "Are the study's single-ingredient riboflavin and exact product specifications verified?", "needed": "Documentation of the trial capsule's molecule/salt, batch, active amount, complete excipients and quality", "role": "Required", "role_reason": "Needed to prevent results for B-vitamin combinations or other formulations from being linked as the same intervention.", "application_exception": "Do not extend the report of riboflavin as a single active nutrient to verified documentation of the exact salt, manufacturing batch or complete excipients.", "criterion": "Record the reported molecule, single-ingredient status and route separately from unverified specifications.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose batch specifications and analytical data for the trial product and directly compare interventions with the same specifications." }, { "item_id": "N03", "question_type": "Actual population and selection", "question": "To what extent do the actual runners match the population in the original claim?", "needed": "2016 WSER inclusion/exclusion criteria, age range, experience, baseline racing ability and special-population data", "role": "Required", "role_reason": "Needed to prevent experienced race participants from being generalized to all athletes or adults in general.", "application_exception": "If exact age/disease criteria are unverified, do not invent criteria beyond the original adult-population scope.", "criterion": "Identify the race-participation setting, selected time-analysis population and unverified detailed population criteria.", "basis": "M03 §3.2.1; detailed population criteria are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Subsequent trials should specify racing experience and selection criteria and predefine population-specific applicability limits." }, { "item_id": "N04", "question_type": "Baseline B2 and diet", "question": "Is it verified whether this is correction of deficiency or additional supplementation on top of adequate intake?", "needed": "Baseline B2 markers/deficiency thresholds, total dietary B2, concurrent supplements and baseline data by group", "role": "Required", "role_reason": "Needed to prevent unreported baseline status from being converted into confirmed absence of deficiency or direct evidence for deficiency treatment.", "application_exception": "Record the supplementation intent, but do not establish deficiency or adequacy in a population whose testing has not been verified.", "criterion": "Distinguish actually measured baseline status from unverified nutritional/dietary dimensions.", "basis": "M03 §3.2.1; detailed population criteria are self-designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.1–3.2.4; details of dose, duration and effect modification are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Measure baseline B2, diet and concurrent supplementation, and plan prespecified effect-modification analyses by deficiency status." }, { "item_id": "N05", "question_type": "Planned dose and timing", "question": "Are the two administrations in one race distinguished from long-term daily dosing?", "needed": "Administration specifications, oral route, timing before the start/at 90 km, and planned total amount", "role": "Required", "role_reason": "Needed to prevent the exploratory search term of 400 mg or a daily dose from replacing the actual intervention.", "application_exception": "The planned total and each person's actual intake are separate; do not label this a long-term 200 mg/day trial.", "criterion": "Link the plan for 100 mg 0.5–1 hour before the start and 100 mg at 90 km to exposure in one race.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.1–3.2.4; details of dose, duration and effect modification are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Fix the timing within the same race, and design studies directly comparing administration timing/doses as separate questions." }, { "item_id": "N06", "question_type": "Actual intake and deviations", "question": "Did everyone actually receive the planned second dose?", "needed": "Individual administration/omission, vomiting, time available for absorption, adherence and analytical-handling records", "role": "Required", "role_reason": "Treating the planned amount as actual exposure in everyone changes the comparison for the selected intervention.", "application_exception": "Do not estimate the amount absorbed after vomiting or the number of participants with omitted doses if the manuscript does not provide them.", "criterion": "Link verified omissions/vomiting to gaps in actual administered amounts and limits on assessing their analytical impact.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; self-developed application; M08 §8.2.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Record administration/deviations for each individual and analyze prespecified effects of assignment separately from effects of adherence." }, { "item_id": "N07", "question_type": "Placebo and active amount", "question": "Are powder mass and active amount distinguished for the color-matched placebo?", "needed": "Placebo batch/ingredients, maltodextrin and beta-carotene powder specifications, and assessment of physiological effects", "role": "Required", "role_reason": "The actual comparison can be explained only after identifying the placebo and its nominal powder mass.", "application_exception": "Do not read 5 mg of 10% powder as 5 mg of active beta-carotene, or convert a nominal calculation into measured content.", "criterion": "Attribute the reported 95 mg/5 mg composition and historical nominal 0.5 mg separately, without assuming physiological equivalence.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose the control capsule's ingredients/color and measured content, and assess nonspecific differences from the intervention." }, { "item_id": "N08", "question_type": "Race care and conflicting medication data", "question": "Are the diet, usual-care and analgesic differences actually internally consistent?", "needed": "Diet/race care in both groups, medication types/participant counts, original table/text and corrections, and analytical handling", "role": "Required", "role_reason": "Prevents concomitant use and internal data conflicts from being attributed to B2's contribution.", "application_exception": "If the text, table and sum across medication types differ, do not select one or calculate a correction.", "criterion": "Preserve the verified lack of standardized care and the conflicting placebo medication-user counts, and leave the unresolved value as null.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; self-developed application; M08 §8.2.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Cross-check individual concomitant-use data against the original table, and preplan recording/handling of common care and rescue treatment." }, { "item_id": "N09", "question_type": "Allocation design", "question": "Has the randomized title been distinguished from actual alternating allocation?", "needed": "Allocation by registration-arrival order, sequence generation, baseline balance and related report identities", "role": "Required", "role_reason": "The word randomized in the title cannot replace the nonrandom procedure in the detailed Methods.", "application_exception": "Do not remove nonrandomized data or treat verification of design identity as satisfaction of causality requirements.", "criterion": "Label alternating allocation and its predictability according to the current detailed allocation record.", "basis": "M08 §8.1–8.2.3; self-developed application; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Subsequent comparisons should disclose the random sequence and its actual implementation, and assess balance in baseline racing ability." }, { "item_id": "N10", "question_type": "Allocation concealment", "question": "Was it impossible to predict or change the allocation sequence?", "needed": "Allocation personnel/concealment implementation, registration process, any breaches and baseline characteristics", "role": "Required", "role_reason": "Needed to prevent the predictability of alternating allocation from being automatically offset by assumed successful concealment.", "application_exception": "Unverified concealment information does not establish the magnitude of concealment failure or the occurrence of manipulation.", "criterion": "Record the allocation actually verified separately from the unverified effectiveness of concealment.", "basis": "M08 §8.1–8.2.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Separate responsibility for sequence generation, storage and implementation from registration procedures, including an audit of the allocation process." }, { "item_id": "N11", "question_type": "Maintenance of blinding", "question": "Are participant/onsite-researcher blinding and noticing urine color distinguished?", "needed": "Blinding implementation, timing of noticing urine color, allocation guesses, assessors and checks of maintained blinding", "role": "Required", "role_reason": "Needed to prevent the mere presence of a color-matched placebo from being used to claim perfect blinding.", "application_exception": "Record whether blinding was maintained even for an objective time outcome, but do not estimate the magnitude of time-related bias solely from urine-color awareness.", "criterion": "Preserve reported blinding together with unverified maintenance and cases of awareness.", "basis": "M08 Table 8.2.a, M03 §3.2.4; self-developed application; M03 §3.2.3, M08 §8.2.2–8.2.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Collect allocation guesses and the timing of awareness, and specify blinding of those recording race times." }, { "item_id": "N12", "question_type": "Starting, finishing and analysis denominators", "question": "What denominators do 44 participants, 37 participants and 32 participants each represent?", "needed": "Group-specific allocation/starting, finishing and data-completeness flow, and the identity of the Table 1 analysis", "role": "Required", "role_reason": "Needed to prevent starter or finisher counts from being substituted as the denominators for the table's means.", "application_exception": "Do not rename alternately allocated participant counts as randomized n or label the results as means for 37 participants.", "criterion": "Link the stages of 22/22 starters, 20/17 finishers and 18/14 with complete data.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose the full participant flow and the actual analysis denominator for each outcome using consistent identifiers." }, { "item_id": "N13", "question_type": "Nonfinishing and missing data", "question": "How were nonfinishing and incomplete data after finishing handled?", "needed": "Individual reasons for nonfinishing/missing data, the analysis plan for the effect in all assigned participants, and raw data", "role": "Required", "role_reason": "Needed to prevent different reasons for loss from being combined or selected completers from being interpreted as the effect in all assigned participants.", "application_exception": "Do not arbitrarily assign times to nonfinishers without finishing times; retain historical subtraction values as separate calculation records.", "criterion": "Separate nonfinishing from incomplete data among finishers, and retain the unverified status of estimation for all starters.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Define the prespecified effect of interest including nonfinishers and missing-data sensitivity analyses, and report the full data flow." }, { "item_id": "N14", "question_type": "Time endpoint and recording", "question": "For what distance, at what time point and with what device was time measured?", "needed": "Official race-completion time, timing device/adjudication, course conditions, record verification and Table 1 location", "role": "Required", "role_reason": "Needed to prevent field-race finishing time from being treated as equivalent to a laboratory test or recovery run.", "application_exception": "If device/adjudication details are unverified, do not declare measurement complete merely because the outcome is objective.", "criterion": "Distinguish the time unit at actual 161.3 km race completion from unverified recording procedures.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M08 Table 8.2.a, M03 §3.2.4; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose official timing records and course/adjudication procedures, and audit measurement errors/differences." }, { "item_id": "N15", "question_type": "Finishing-time analysis hierarchy", "question": "Was finishing time a prespecified primary efficacy endpoint?", "needed": "Registration/protocol/SAP, endpoint/time-point hierarchy, the table's purpose and reasons for changes", "role": "Required", "role_reason": "Needed to prevent time in a characteristics table from being relabeled as a prespecified primary (1st) efficacy outcome.", "application_exception": "Do not convert failure to acquire the plan into confirmed selective reporting or lack of registration.", "criterion": "Preserve the recovery focus of the study and the location of time in the characteristics table, and indicate that the prespecified hierarchy is unverified.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M08 Table 8.2.a, M04 §4.6.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Fix the primary/supporting role of finishing time, testing hierarchy and handling of multiple comparisons before the race." }, { "item_id": "N16", "question_type": "Means, SD and units", "question": "Are the Table 1 means and dispersion measures attributed to the same population/units?", "needed": "Group-specific complete-data n, mean time, SD notation, and original table/units", "role": "Required", "role_reason": "Needed to prevent SD from being read as SE or CI, or linked to a different denominator.", "application_exception": "Do not use mean±SD as individual differences/between-group CI, or extract precision beyond the table summaries.", "criterion": "Preserve 27.26±2.36 hours for B2 n=18 and 27.08±2.88 hours for placebo n=14 as mean±SD.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose the dispersion definition for each outcome together with precise numerical values/denominators." }, { "item_id": "N17", "question_type": "Nonsignificance and interpretation limits", "question": "Has nonsignificance for time been kept from being converted into an effect of 0 or equivalence?", "needed": "The original table's no-difference statement, coherent between-group estimates/intervals and a validated important-difference criterion", "role": "Required", "role_reason": "Needed to prevent nonsignificant results from being favorably omitted or expressed as definitive absence of effect.", "application_exception": "Do not obscure nonsignificance with favorable results for other recovery outcomes, or equate nonsignificance with exclusion of important benefit.", "criterion": "Link the retained nonsignificant result and current interpretation limits to the same endpoint.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M15 §15.3.1–15.3.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Prespecify coherent between-group intervals and important-difference criteria to provide interpretation beyond significance." }, { "item_id": "N18", "question_type": "Original CI and exact P", "question": "Are author-reported between-group CI, exact P and adjusted estimates available?", "needed": "CI for the original time outcome, exact test P, adjusted model/estimand and results table", "role": "Required", "role_reason": "Needed to prevent recalculated summary statistics from being used as original author reports or adjusted causal estimates.", "application_exception": "If an original value is null, do not fill the gap even when historical calculations exist.", "criterion": "Separate verification status for original CI, exact P and adjusted effect from historical recalculation.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application; M15 §15.3.1–15.3.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose the original between-group CI/P and model/denominator for the prespecified effect of interest on finishing time." }, { "item_id": "N19", "question_type": "Historical mean difference and direction", "question": "Are the sign and descriptive meaning of the retained mean difference preserved?", "needed": "Historical arithmetic inputs, B2−placebo direction, original mean-difference values/limits and calculation provenance", "role": "Required", "role_reason": "Needed to prevent a positive time difference from being converted into new causal harm or significant delay.", "application_exception": "Perform no new calculations in this work, and retain both rounded displays and the original stored floating-point values.", "criterion": "Specify the direction of the historical +0.18 hours (+10.8 minutes) and its limitation as a descriptive value for a selected sample.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Subsequent research should report the prespecified direction and between-group estimates/intervals for the overall effect of interest." }, { "item_id": "N20", "question_type": "Historical pooled interval", "question": "Can the assumptions of the equal-variance t-reconstructed interval be verified?", "needed": "Original retained pooled-calculation values, inputs, assumptions, selected sample and distinction from original reporting", "role": "Supplementary", "role_reason": "Needed to preserve existing arithmetic without promoting it to an original CI or causal precision.", "application_exception": "Do not establish that the authors used the equal-variance t subtype. Reconstruction does not remedy missingness/confounding.", "criterion": "Attribute the existing CI/P/SE/df solely to an assumption-dependent descriptive model.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application; M15 §15.3.1–15.3.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose participant-level data and a prespecified model to examine direct estimation that accounts for selection/nonrandomization limitations." }, { "item_id": "N21", "question_type": "Historical Welch sensitivity analysis", "question": "Were the unequal-variance sensitivity results also preserved as a separate model?", "needed": "Retained Welch values, assumptions, inputs, differences from pooled results and verification status of the original interval", "role": "Supplementary", "role_reason": "Needed to prevent model selection that presents only favorable intervals or relabels them as author CI.", "application_exception": "Do not classify differences between sensitivity-model results as a conflict within the same source data. Perform no new recalculation.", "criterion": "Link the historical Welch CI/P/SE/df to that model and explain the remaining causal limitations.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M08 §8.2.2, M15 §15.3.1; self-developed application; M15 §15.3.1–15.3.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Prespecify variance assumptions and sensitivity analyses for missingness/confounding, and report model-specific results transparently." }, { "item_id": "N22", "question_type": "Important difference and equivalence", "question": "Is there a basis for deciding how much faster a time constitutes important benefit?", "needed": "Justified important-difference and equivalence thresholds for the same race/population, and appropriate original estimation intervals", "role": "Required", "role_reason": "Needed to prevent CX in the existing score or nonsignificance from being used to exclude important benefit.", "application_exception": "Do not create universal thresholds for minutes, participant numbers or duration, or force NNT onto a continuous-time question.", "criterion": "Distinguish the unverified important difference, unestablished equivalence and inapplicability of NNT.", "basis": "M15 §15.3.1–15.3.3; self-developed application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Justify an important difference in the runner/race context and prespecify a precision/equivalence design incorporating it." }, { "item_id": "N23", "question_type": "Confounding and adjusted effect of interest", "question": "Is a comparative effect accounting for baseline racing ability and selection verified?", "needed": "Baseline racing ability, experience on the same course, nutritional/care covariates and prespecified adjustment/analysis of all participants", "role": "Required", "role_reason": "Needed to prevent the selected-completer mean difference from being read as the effect of B2 in all assigned participants.", "application_exception": "Lack of adjustment does not establish the magnitude of bias; do not adjust values using a new model.", "criterion": "Link the unverified adjusted effect and baseline balance to limitations on the current effect of interest.", "basis": "M08 §8.1–8.2.3; self-developed application; M08 §8.2.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Measure racing ability before allocation and prespecify the effect of interest and handling of covariates/losses." }, { "item_id": "N24", "question_type": "Acquisition of registration and plans", "question": "Have the official registration, protocol and SAP been compared with the original report?", "needed": "Full original registration/protocol/SAP, versions/dates and endpoint/analysis comparisons", "role": "Required", "role_reason": "Needed to prevent ethics approval or study existence from being treated as reading the registration/plans.", "application_exception": "S01 registration_id=null does not prove absence of an external registration that is currently unverified.", "criterion": "Indicate the scope of plans acquired/read and the scope not compared according to the actions actually taken in this work.", "basis": "Material collection/selection principles in M04 §4.5–4.6; distinctions between access and reading and the hyperlink contract are self-designed; M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules; M08 Table 8.2.a, M04 §4.6.3; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose original plans and change histories, and compare outcome-specific plan adherence/reasons for changes." }, { "item_id": "N25", "question_type": "Conference report and same family", "question": "Are the conference title and original journal article being counted as independent replications?", "needed": "S01/S04 original reports, full conference text, cohort/time-point/participant linkage and design wording", "role": "Required", "role_reason": "Needed to prevent a companion report from the same investigators/intervention from being counted as two race trials.", "application_exception": "Do not overstate a probable same-family link as a confirmed finding about participant independence/overlap.", "criterion": "Preserve probable-companion status, lack of acquired full text and conflicting design wording in the title; do not count it as a separate replication.", "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a self-developed application; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Link participants, registrations and time points across related reports, and disclose a map of unique families and outcome locations." }, { "item_id": "N26", "question_type": "Recovery and other favorable outcomes", "question": "Are positive signals for pain/400 m recovery being substituted as time evidence?", "needed": "Endpoint-specific results, time points, tests/hierarchy and finishing-time separation records from the same study", "role": "Required", "role_reason": "Needed to preserve favorable results without obscuring the no-difference result for the selected finishing-time outcome.", "application_exception": "Do not add numbers/CI to recovery signals for which the currently retained manuscript supplies no numerical values.", "criterion": "Distinguish the endpoints of some recovery/pain signals from the actual time outcome.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M03 §3.2.4; self-defined extension boundary", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Prespecify race performance and post-race recovery separately, and report endpoint-specific estimates/intervals and multiple comparisons." }, { "item_id": "N27", "question_type": "Ex PLUS and combination product", "question": "Does time to exhaustion with a combination product in nonathletes answer the single-ingredient B2 race-time question?", "needed": "S02 ingredient table, population, exposure/washout, actual performance test and registration/original results", "role": "Supplementary", "role_reason": "Needed to prevent differences in composition, population and endpoint in indirect evidence from being combined as replications of single-ingredient B2.", "application_exception": "Do not isolate the B2 component's effect from a combination product in nonathletes or convert it into race finishing time.", "criterion": "Record the boundary of a combination product in 32 healthy nonathletes, 28 days, a 14-day washout and time to exhaustion at 85% VO2max.", "basis": "M03 §3.2.1; detailed population criteria are self-designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Design a direct comparison in the same ultramarathon population differing only in single-ingredient B2." }, { "item_id": "N28", "question_type": "1984 swimming study and unresolved status", "question": "Have the swimming article's eligibility and numerical values been verified?", "needed": "Full original 1984 article, age/ingredient/dose, design, performance test, denominators and effect/intervals", "role": "Supplementary", "role_reason": "Needed to prevent bibliographic discovery from being promoted to a performance effect or independent replication.", "application_exception": "Do not use historical inaccessibility of the original as absence of the article/study; distinguish it from access not attempted in the current work.", "criterion": "Display title/bibliographic identity separately from unverified eligibility/numerical values.", "basis": "Material collection/selection principles in M04 §4.5–4.6; distinctions between access and reading and the hyperlink contract are self-designed; M03 §3.2.1; detailed population criteria are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "In a subsequent review that acquires the original, verify the actual sport, test and population, and separate evidence according to directness." }, { "item_id": "N29", "question_type": "1992 population correction", "question": "Have the Winters1992 population and the swimming study been separated?", "needed": "S06 bibliography, original article/abstract, exercise-adaptation/nutrient-requirement endpoints and QA01 correction", "role": "Supplementary", "role_reason": "Prevents a mistaken population link in exploratory queries from being carried over to numerical values from another article.", "application_exception": "Do not fill in actual performance numbers or effects solely from title verification.", "criterion": "Separate the exercise-adaptation/requirement question in older women from the elite-swimming candidate.", "basis": "M03 §3.2.1; detailed population criteria are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Subsequent original-source review should first verify each population, endpoint and ingredient, then extract by independent question." }, { "item_id": "N30", "question_type": "Direction of exercise→B2 status", "question": "Is post-exercise B2 status in adult men an effect of supplementation→time?", "needed": "S07 original article, exposure/outcome direction, nutritional-status tests/time points and actual comparison", "role": "Supplementary", "role_reason": "Prevents nutritional-status responses to exercise from being mixed with supplement effects on performance in the reverse direction.", "application_exception": "Do not convert facts about status endpoints into supplementation effects or clinical deficiency treatment.", "criterion": "Indicate the exercise→B2 status direction shown by the current title/facts and its difference from the performance question.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M03 §3.2.4; self-defined extension boundary", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Design the performance-improvement question separately as a comparison differing only in B2 exposure." }, { "item_id": "N31", "question_type": "Female status and original Methods", "question": "Is the exercise challenge in women by fitness level a comparison of oral B2 versus placebo?", "needed": "S09 original abstract/Methods, exposure/exclusion criteria, results, and original location and registration of NL7891", "role": "Supplementary", "role_reason": "Needed to prevent exercise-challenge observations from being called a single-ingredient B2 supplementation trial.", "application_exception": "Verifying a registration number in the original Methods is separate from reading the full official registration.", "criterion": "Link the exclusion of B2-containing supplement use, exercise challenge, status endpoint and original NL7891 separately.", "basis": "M03 §3.2.1; detailed population criteria are self-designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptations are self-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are self-designed; M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "A performance-comparison question for single-ingredient B2 requires a separate intervention/control trial in the same population." }, { "item_id": "N32", "question_type": "Registration discovery and mistaken identity", "question": "Has discovery of the female study's registration been distinguished from the adjacent TCTR entry?", "needed": "Official full text/identity of NL7891 and OMON candidates, comparison with the original Methods, and discovery-page structure", "role": "Supplementary", "role_reason": "Needed to prevent registration numbers in adjacent search results from being used to fill in the original study's identity/methods.", "application_exception": "OMON aliases remain at the discovery level; do not promote unread official details to verified methods.", "criterion": "Preserve separation of the adjacent TCTR entry, nonacquisition of official details and the S09 original Methods basis.", "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a self-developed application; material collection/selection principles in M04 §4.5–4.6; distinctions between access and reading and the hyperlink contract are self-designed; M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Compare the identities of the official registration and original article using source materials, and mark uncertain aliases." }, { "item_id": "N33", "question_type": "Replication and search scope", "question": "Are repeated citations in reviews and limited searching being read as independent replication or absence of studies?", "needed": "Unique-family/report map, actual search records, registration/unpublished/correction scope and full review article", "role": "Required", "role_reason": "Needed to prevent one family and an incomplete search from being converted into replication success/failure or 0 studies worldwide.", "application_exception": "The 63 web queries and 3 failures are historical records, not new successful searches or current exhaustive verification.", "criterion": "Display the single direct family, unverified independent replication, repeated citations in reviews and search limitations together.", "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a self-developed application; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are self-designed; M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules; M04 §4.6.1–4.6.2, M15 §15.3.1; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Subsequent reviews should transparently record the scope of searches, failures, registrations and corrections, and link independent comparisons addressing the same question." }, { "item_id": "N34", "question_type": "Support and independence", "question": "What is the scope of foundation/public support and no-conflict declarations?", "needed": "Funding/product provision, donor provenance, support roles, author declarations/employment and family map", "role": "Supplementary; required for independence claims", "role_reason": "Needed to prevent reported declarations from being used as proof of external review, absence of bias or independent replication.", "application_exception": "Do not fill gaps concerning donors, product provision or roles in foundation/public support with an assumption of no corporate influence.", "criterion": "Explain actual funding/declarations and the boundaries of unverified support information.", "basis": "Chamgap's own independence/attribution criteria. The official methods sections in this pilot do not validate every detail of this item; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Disclose support roles, product provision, all interests and linkage to independent study families." }, { "item_id": "N35", "question_type": "Vomiting and temporal signal", "question": "What can be concluded about vomiting after the 90 km dose?", "needed": "Number of participants with vomiting, onset/recovery, administration/discontinuation/re-exposure, alternative causes, and placebo ascertainment/denominators", "role": "Supplementary; required for harm interpretation", "role_reason": "Needed to separate the occurrence of an event after dosing from comparative risk/causation.", "application_exception": "Do not infer the amount absorbed after vomiting or other causes, and do not convert 2 participants into an incidence rate.", "criterion": "Preserve the record of 2 participants in the B2 group within 1 hour after administration at 90 km as a temporal signal.", "basis": "M19 §19.1.2–19.2.4; self-developed application; M19 §19.1.2–19.2.4; detailed distinctions are self-designed; design-specific harm questions in M19 §19.2; details of temporal relationships are self-designed; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are self-designed; Chamgap's own interpretation boundary. Informed by M19 principles, not execution of an official causality tool", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Systematically collect exposure/event timing, discontinuation/recovery, alternative explanations and concomitant use, and plan comparable harm analyses." }, { "item_id": "N36", "question_type": "Urine color and awareness events", "question": "Do the 3 participants versus 1 participant noticing urine color represent harm incidence?", "needed": "Definition/timing of awareness, participant counts, ascertainment scope, actual denominators in both groups and blinding checks", "role": "Supplementary; required for harms/blinding", "role_reason": "Needed to prevent awareness counts from being converted into systematic adverse-event incidence or a confirmed proportion with allocation unblinded.", "application_exception": "Do not automatically substitute the table's time-analysis denominator or the starter denominator for the awareness-ascertainment denominator.", "criterion": "Link the report of 3 participants versus 1 participant to limits on interpreting blinding maintenance/safety.", "basis": "M08 Table 8.2.a, M03 §3.2.4; self-developed application; M19 §19.1.2–19.2.4; self-developed application; M19 §19.1.2–19.2.4; detailed distinctions are self-designed", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Collect awareness/allocation guesses identically in both groups and disclose ascertainment denominators and onset timing." }, { "item_id": "N37", "question_type": "Safety ascertainment and denominators", "question": "Were adverse events, serious events and discontinuations due to harm systematically counted?", "needed": "AE/SAE definitions in both groups, ascertainment procedures, participants/events, exposure time, discontinuations and loss denominators", "role": "Supplementary; required for safety claims", "role_reason": "Needed to prevent a few event records and efficacy data from being converted into complete safety assurance.", "application_exception": "Do not use unreported/unverified information as 0 events or proof of no serious events.", "criterion": "Retain currently verified signals and specific gaps in systematic ascertainment/denominators.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are self-designed; M19 §19.1.2–19.2.4; self-developed application; M19 §19.1.2–19.2.4; detailed distinctions are self-designed; M19 §19.1.2–19.2.4, M04 §4.6.3; self-developed application; Chamgap's own interpretation boundary. Informed by M19 principles, not execution of an official causality tool", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Track exposure and losses among all assigned participants, and record events, participants and discontinuations using the same procedures in both groups." }, { "item_id": "N38", "question_type": "Official safety context", "question": "Have the meanings of no established UL and no known interactions been appropriately limited?", "needed": "S03 official safety/interaction original text, update date, evidence scope and data on the same exposure/population", "role": "Supplementary; required for general safety extensions", "role_reason": "Needed to prevent the lack of an established upper limit from being read as unlimited high-dose safety.", "application_exception": "Do not count a general official document as a direct comparative harm result for this race/all concomitant use.", "criterion": "Indicate that the lack of an established UL reflects limited harm data and specify the scope of verification of known interactions.", "basis": "M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules; M19 §19.1.2–19.2.4; self-developed application; Chamgap's own interpretation boundary. Informed by M19 principles, not execution of an official causality tool", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "Review harm data addressing the same dose/duration/concomitant use and official updates separately." }, { "item_id": "N39", "question_type": "Long-term use, special populations and interference", "question": "Does the evidence also answer dose/duration, special-population and test-interference questions beyond one race?", "needed": "Direct evidence on long-term/repeated dosing, vulnerable populations/renal or hepatic conditions, pregnancy/lactation/children, concomitant use and test interference", "role": "Supplementary; required for scope extensions", "role_reason": "Needed to prevent brief race data from being generalized to overall safety, optimal dosing or efficacy in all runners.", "application_exception": "Do not require every extension study for the narrow finishing-time table, but explicitly mark unverified information in extension claims.", "criterion": "Distinguish the direct one-race scope from unverified long-term/special-population, interaction and interference questions.", "basis": "M03 §3.2.1–3.2.4; details of dose, duration and effect modification are self-designed; M19 §19.1.2–19.2.4; self-developed application", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "For each needed extension, separately design a study with the appropriate population, duration and focus on harms/interactions or test interference." }, { "item_id": "N40", "question_type": "Current reading and preservation of original values", "question": "Has this summary review been distinguished from historical full-text and verdict records?", "needed": "Current original/snapshot SHA, scope actually read, historical access/calculations, existing grade/score and reading receipts", "role": "Required", "role_reason": "Needed to prevent full-text access/self-review on 2026-09-16 from being represented as original-source reading or independent certification today.", "application_exception": "Distinguish stored-original-file/hash null values from unexamined historical files, and do not claim a new download/reassessment was performed.", "criterion": "Separately record the original stored summary's bytes/date, current summary reading, nonreading of the original article and preservation of D/30/Caution.", "basis": "Material collection/selection principles in M04 §4.5–4.6; distinctions between access and reading and the hyperlink contract are self-designed; M04 §4.5, §4.6.3; limits on the current material conversion follow the user-defined scope and self-designed rules", "condition_origin": "Development criteria designed after individually reading the currently retained 3124 materials. Not a blinded or preregistered assessment, execution of an official tool, or certification", "proposed_research": "In a subsequent case where new evidence is permitted, preserve original values/previous originals together with dates, access and locations/versions before reviewing linkage conditions." } ] }