{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "LG2055 drinkable yogurt × Gaps in direct evidence for fewer cold infections",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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 in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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 studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "How is the selected infection-incidence question distinguished from the symptom-day sheet?",
      "needed": "Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How is the selected infection-incidence question distinguished from the symptom-day sheet?",
      "application_exception": "Do not transfer the sibling C grade or positive symptom-day findings into direct evidence or a grade for infection incidence.",
      "criterion": "Separate original information about Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; Detailed separation rules are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A prespecified research question distinguishing symptom-days from confirmed infection events"
    },
    {
      "item_id": "N02",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What are the selected grade/note and the absent score, status and axes?",
      "needed": "Subclaim ? grade/note, absent score/status/axes and parent history",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the selected grade/note and the absent score, status and axes?",
      "application_exception": "Do not fill subclaim values or claim a current review pass using the parent score of 50 or symptom-endpoint P/E+ axes.",
      "criterion": "Separate original information about Subclaim ? grade/note, absent score/status/axes and parent history from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate preservation of the original grade from updates with additional evidence"
    },
    {
      "item_id": "N03",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Who were the actual participants, and how was susceptibility to colds defined?",
      "needed": "Recruitment of healthy Japanese adults aged 20–64 who were prone to colds",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Who were the actual participants, and how was susceptibility to colds defined?",
      "application_exception": "Do not extend healthy-adult findings to infection prevention for all ages, illnesses or immunocompromised people.",
      "criterion": "Separate original information about Recruitment of healthy Japanese adults aged 20–64 who were prone to colds from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the population and infection/symptom definitions"
    },
    {
      "item_id": "N04",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What are the identities of the LG2055 study drink and strain?",
      "needed": "LG2055 drinkable yogurt and the original strain name",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the identities of the LG2055 study drink and strain?",
      "application_exception": "Do not generalize an isolated effect to generic probiotics or other strains/products, or arbitrarily rename the strain.",
      "criterion": "Separate original information about LG2055 drinkable yogurt and the original strain name from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the exact study drink and strain"
    },
    {
      "item_id": "N05",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the control yogurt and comparison of interest?",
      "needed": "Identical yogurt with only LG2055 removed and the shared ingredients",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the control yogurt and comparison of interest?",
      "application_exception": "Do not transfer symptom-day results into infection prevention by yogurt as a whole or an isolated LG2055 effect on confirmed infections.",
      "criterion": "Separate original information about Identical yogurt with only LG2055 removed and the shared ingredients from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the contrast on an identical-yogurt background"
    },
    {
      "item_id": "N06",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the intake amount, organism count, frequency and actual adherence?",
      "needed": "Target/actual study-drink exposure, adherence and deviations",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the intake amount, organism count, frequency and actual adherence?",
      "application_exception": "Do not create intake amounts, dosing instructions or organism-count conversions for probiotics, drinks or products.",
      "criterion": "Separate original information about Target/actual study-drink exposure, adherence and deviations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating intended provision from actual exposure"
    },
    {
      "item_id": "N07",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the 12-week winter observation, follow-up timing and longer-term scope?",
      "needed": "Winter observation, 12 weeks, time points and post-study outcomes",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the 12-week winter observation, follow-up timing and longer-term scope?",
      "application_exception": "Do not turn 12-week symptom observation into continuous infection prevention or effects across an entire season or the long term.",
      "criterion": "Separate original information about Winter observation, 12 weeks, time points and post-study outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing duration and symptom/infection outcomes"
    },
    {
      "item_id": "N08",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Was laboratory-confirmed infection incidence actually measured?",
      "needed": "Pathogen-confirmed infection events and testing/diagnostic definitions",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Was laboratory-confirmed infection incidence actually measured?",
      "application_exception": "Preserve the original statement of nonmeasurement without newly judging infection incidence or effects as zero, or prevention as successful.",
      "criterion": "Separate original information about Pathogen-confirmed infection events and testing/diagnostic definitions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research defining symptom questionnaires and confirmed infection events separately"
    },
    {
      "item_id": "N09",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What was the scope of clinician confirmation, pathogen types and testing times?",
      "needed": "Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the scope of clinician confirmation, pathogen types and testing times?",
      "application_exception": "Do not invent clinician adjudication or testing absent from the summary, or attribute symptoms to a particular infection.",
      "criterion": "Separate original information about Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research defining confirmation methods, pathogens and observation times"
    },
    {
      "item_id": "N10",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are there infected-person counts, first/recurrent events and incidence denominators?",
      "needed": "People/events, time at risk, reinfections/repeats and denominators",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are there infected-person counts, first/recurrent events and incidence denominators?",
      "application_exception": "Do not convert symptom-day proportions into proportions of infected people, infection-event counts or incidence.",
      "criterion": "Separate original information about People/events, time at risk, reinfections/repeats and denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing first/recurrent events and person/time denominators"
    },
    {
      "item_id": "N11",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What units underlie the original runny-nose numerators, denominators and absolute difference?",
      "needed": "2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What units underlie the original runny-nose numerators, denominators and absolute difference?",
      "application_exception": "Do not recalculate the original −5.0 percentage points or convert it into infection risk differences, RR/NNT or individual prevention probabilities.",
      "criterion": "Separate original information about 2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing estimands for people, observation days and symptom-days"
    },
    {
      "item_id": "N12",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What do the other symptom proportions and cough P value mean?",
      "needed": "Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What do the other symptom proportions and cough P value mean?",
      "application_exception": "Do not combine symptoms or time points into new confirmed-infection counts or a composite success score.",
      "criterion": "Separate original information about Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying symptom-specific outcomes and the planned hierarchy"
    },
    {
      "item_id": "N13",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What are the analysis units for people, observation days, symptoms and repeated records?",
      "needed": "Repeated diaries from the same people, symptoms/groups/times and correlation",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the analysis units for people, observation days, symptoms and repeated records?",
      "application_exception": "Do not reanalyze all observation days as independent binary observations or inflate the sample size.",
      "criterion": "Separate original information about Repeated diaries from the same people, symptoms/groups/times and correlation from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing people, repeated records and events"
    },
    {
      "item_id": "N14",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are questionnaire missingness, recording adherence and unmeasured infections distinguished?",
      "needed": "Missing diaries/symptoms, unmeasured infections and imputation/denominators",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are questionnaire missingness, recording adherence and unmeasured infections distinguished?",
      "application_exception": "Do not fill missing days as symptom-free/infection-free or treat unmeasured infection as a zero effect.",
      "criterion": "Separate original information about Missing diaries/symptoms, unmeasured infections and imputation/denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing missing records from unmeasured infection events"
    },
    {
      "item_id": "N15",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?",
      "needed": "Original primary symptom-days, hierarchical composite and secondary hierarchy",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?",
      "application_exception": "Do not establish overall infection-prevention efficacy or a new composite outcome from one selected positive symptom.",
      "criterion": "Separate original information about Original primary symptom-days, hierarchical composite and secondary hierarchy from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying symptom/infection and primary/secondary estimands"
    },
    {
      "item_id": "N16",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What was the original discrepancy between the registry ID, claimed preregistration and public date?",
      "needed": "UMIN000045901, original planned-start/public dates and unread external records",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original discrepancy between the registry ID, claimed preregistration and public date?",
      "application_exception": "Do not replace UMIN with NCT, calculate the date gap or upgrade it to a current registry-review pass.",
      "criterion": "Separate original information about UMIN000045901, original planned-start/public dates and unread external records from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design; Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records separating plans from publication/amendment events"
    },
    {
      "item_id": "N17",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the actual randomization, identical-yogurt and double-blinding procedures?",
      "needed": "Allocation/concealment, baseline balance, blinding and awareness of conditions",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the actual randomization, identical-yogurt and double-blinding procedures?",
      "application_exception": "Do not certify successful blinding, absence of bias or independence from the original design label or B1 axis.",
      "criterion": "Separate original information about Allocation/concealment, baseline balance, blinding and awareness of conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "An allocation/blinding plan for identical yogurt"
    },
    {
      "item_id": "N18",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the original randomized, intake-completer, exclusion and PPS counts?",
      "needed": "200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96)",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original randomized, intake-completer, exclusion and PPS counts?",
      "application_exception": "Do not calculate or add new dropout/exclusion counts or proportions from 200/198/193.",
      "criterion": "Separate original information about 200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96) from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing randomized, completer and analysis populations"
    },
    {
      "item_id": "N19",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the PPS, completer, ITT and other analysis populations and missing-data handling?",
      "needed": "Original primary-efficacy PPS versus the estimand for all randomized participants",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the PPS, completer, ITT and other analysis populations and missing-data handling?",
      "application_exception": "Do not replicate symptom-day PPS findings as direct effects for all randomized people or confirmed-infection populations.",
      "criterion": "Separate original information about Original primary-efficacy PPS versus the estimand for all randomized participants from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying assignment/adherence effects and missingness"
    },
    {
      "item_id": "N20",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Were baseline infection risk and shared lifestyle/treatment exposures verified?",
      "needed": "Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were baseline infection risk and shared lifestyle/treatment exposures verified?",
      "application_exception": "Do not add infection-prevention/treatment components absent from the original as actual trial exposures or instructions.",
      "criterion": "Separate original information about Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying shared conditions and infection risk"
    },
    {
      "item_id": "N21",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "How were subjective questionnaires collected and adjudicated?",
      "needed": "Diaries, symptom definitions/severity and assessors versus testing",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How were subjective questionnaires collected and adjudicated?",
      "application_exception": "Do not automatically classify symptomatic colds as clinician/test-confirmed diagnoses.",
      "criterion": "Separate original information about Diaries, symptom definitions/severity and assessors versus testing from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A measurement plan separating subjective symptoms from confirmed infection"
    },
    {
      "item_id": "N22",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the original unreported CIs, precision and missing direct infection estimates?",
      "needed": "Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original unreported CIs, precision and missing direct infection estimates?",
      "application_exception": "Do not calculate new CI/RR/NNT from aggregate days or transfer them into infection-effect estimates.",
      "criterion": "Separate original information about Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying units, estimands and precision"
    },
    {
      "item_id": "N23",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are within/between-group symptom-days, periods and event estimands distinguished?",
      "needed": "Original day-proportion contrast versus individuals/infection, adjustment and models",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are within/between-group symptom-days, periods and event estimands distinguished?",
      "application_exception": "Do not interpret aggregate proportions as reduced individual infection risk or guaranteed prevention.",
      "criterion": "Separate original information about Original day-proportion contrast versus individuals/infection, adjustment and models from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating symptom-days, people/events and within/between-group contrasts"
    },
    {
      "item_id": "N24",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were the original sponsor, employee/contractor and product-development details?",
      "needed": "Four MEGMILK employees, a KSO employee and product/support scope",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original sponsor, employee/contractor and product-development details?",
      "application_exception": "Do not add the contractor employee to the four company employees or regrade original values solely because of sponsorship.",
      "criterion": "Separate original information about Four MEGMILK employees, a KSO employee and product/support scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Explicit support and research-decision/analysis roles"
    },
    {
      "item_id": "N25",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?",
      "needed": "Kobatake 2022 citation and relationships within the same population/observations",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?",
      "application_exception": "One report slot does not certify one direct confirmed-infection trial or a final clinically independent count.",
      "criterion": "Separate original information about Kobatake 2022 citation and relationships within the same population/observations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records distinguishing reports from study families"
    },
    {
      "item_id": "N26",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Is there direct replication or independent confirmation for confirmed infection?",
      "needed": "Direct trials of the selected infection incidence, confirmation methods and identities",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Is there direct replication or independent confirmation for confirmed infection?",
      "application_exception": "Do not count sibling symptom reports as independent infection trials or extend the original single trial into a current worldwide absence-of-research finding.",
      "criterion": "Separate original information about Direct trials of the selected infection incidence, confirmation methods and identities from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate research defining confirmed-infection events"
    },
    {
      "item_id": "N27",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What is the applicability to other products/strains, populations and settings?",
      "needed": "Original LG2055 identical-yogurt/winter-adult context versus other scopes",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is the applicability to other products/strains, populations and settings?",
      "application_exception": "Do not extend findings into general immune improvement, prevention of all infections, product recommendations or intake instructions.",
      "criterion": "Separate original information about Original LG2055 identical-yogurt/winter-adult context versus other scopes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying direct applicability"
    },
    {
      "item_id": "N28",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?",
      "needed": "Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?",
      "application_exception": "Do not turn positive symptom-day findings into laboratory-confirmed prevention, improved immunity or treatment substitution.",
      "criterion": "Separate original information about Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating symptom questions from confirmed-infection/clinical questions"
    },
    {
      "item_id": "N29",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What are persistence, repeated-use or prevention effects beyond 12 weeks?",
      "needed": "Exposure duration, after discontinuation and other/long-term infection outcomes",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are persistence, repeated-use or prevention effects beyond 12 weeks?",
      "application_exception": "Do not extend 12-week symptom findings into year-round prevention or long-term safety/intake schedules.",
      "criterion": "Separate original information about Exposure duration, after discontinuation and other/long-term infection outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing persistence/repetition questions from infection events"
    },
    {
      "item_id": "N30",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What was read in the summary, what remains externally unread, and what do source links mean?",
      "needed": "Complete existing review summary, abstract/full text/registry and needed materials",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was read in the summary, what remains externally unread, and what do source links mean?",
      "application_exception": "Preserve absent DOI/PMCID fields in the original bibliography; do not declare external acquisition/reading or failed access based on an ID/URL.",
      "criterion": "Separate original information about Complete existing review summary, abstract/full text/registry and needed materials from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records separating summary preservation from newly acquired materials"
    },
    {
      "item_id": "N31",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What are the original bilingual text, dates/corrections, axes, absences and history?",
      "needed": "Languages, dates, empty values, parent C50/axes and original verdict narrative",
      "role": "Required",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the original bilingual text, dates/corrections, axes, absences and history?",
      "application_exception": "Do not inherit the original 200-person rule, flaw scoring or cross-check narrative as current clinical review/rescoring, or invent absent fields.",
      "criterion": "Separate original information about Languages, dates, empty values, parent C50/axes and original verdict narrative from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate original values/absences from new updates"
    },
    {
      "item_id": "N32",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What was the original scope of adverse-event collection and related serious safety signals?",
      "needed": "Collection/definitions, all events, severity and relatedness",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original scope of adverse-event collection and related serious safety signals?",
      "application_exception": "Do not turn no reported related serious signal into zero adverse effects of every kind or guaranteed safety.",
      "criterion": "Separate original information about Collection/definitions, all events, severity and relatedness from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying harm collection separately from efficacy"
    },
    {
      "item_id": "N33",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are dairy allergy and lactose discomfort actual trial events?",
      "needed": "Original cautionary context versus the relevant population/events",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are dairy allergy and lactose discomfort actual trial events?",
      "application_exception": "Do not create product-checking/avoidance, intake/treatment instructions or allergy/discomfort events absent from the original.",
      "criterion": "Separate original information about Original cautionary context versus the relevant population/events from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying safety questions for vulnerable populations"
    },
    {
      "item_id": "N34",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Were arm-specific harms, collection populations/denominators and effects verified?",
      "needed": "200/198/PPS 193 versus separate harm denominators/comparisons",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were arm-specific harms, collection populations/denominators and effects verified?",
      "application_exception": "Do not automatically use PPS 193/97/96 as valid harm denominators or calculate zero events, incidence or CIs.",
      "criterion": "Separate original information about 200/198/PPS 193 versus separate harm denominators/comparisons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing efficacy populations from harm-collection populations"
    },
    {
      "item_id": "N35",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What were harm timing and post-study/delayed follow-up?",
      "needed": "12-week exposure, event/follow-up times and longer-term scope",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were harm timing and post-study/delayed follow-up?",
      "application_exception": "Do not turn 12-week symptom observation into completed long-term safety verification.",
      "criterion": "Separate original information about 12-week exposure, event/follow-up times and longer-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing timing and delayed harms"
    },
    {
      "item_id": "N36",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "How do shared yogurt, baseline/infection exposures and harm relatedness connect?",
      "needed": "LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How do shared yogurt, baseline/infection exposures and harm relatedness connect?",
      "application_exception": "Do not establish symptoms as outcomes of a specific pathogen or drink-related harm, or add cold-management/treatment instructions.",
      "criterion": "Separate original information about LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing the exposure of interest from alternative causes"
    },
    {
      "item_id": "N37",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?",
      "needed": "Original 198 completers/5 exclusions, PPS and harm/missingness reasons",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?",
      "application_exception": "Do not convert the original 5 exclusions into people with adverse effects or calculate a new randomized/completer difference.",
      "criterion": "Separate original information about Original 198 completers/5 exclusions, PPS and harm/missingness reasons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating missingness from harm-related discontinuation"
    },
    {
      "item_id": "N38",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "How are independent harm data distinguished from observations in the same trial?",
      "needed": "Separate safety-report identities, exposures/populations and overlap",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are independent harm data distinguished from observations in the same trial?",
      "application_exception": "No separate current slot does not establish the absence of all external harm reports.",
      "criterion": "Separate original information about Separate safety-report identities, exposures/populations and overlap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Independent safety research with clear populations/exposures"
    },
    {
      "item_id": "N39",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?",
      "needed": "Healthy adults versus allergy/illness and long-term scope",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?",
      "application_exception": "Do not propose implementation instructions for probiotic/product intake, cold management/prevention or treatment substitution.",
      "criterion": "Separate original information about Healthy adults versus allergy/illness and long-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating population and long-term safety questions"
    },
    {
      "item_id": "N40",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?",
      "needed": "Different benefits/events, original safety and harm causality",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?",
      "application_exception": "Do not newly classify unmeasured infection as zero effect, established harm or guaranteed safety.",
      "criterion": "Separate original information about Different benefits/events, original safety and harm causality from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating different outcomes and estimands"
    },
    {
      "item_id": "N41",
      "question_type": "Scope and evidence gaps for infection incidence versus symptom-days",
      "question": "How are follow-up materials, historical candidates/versions and incomplete prior content review connected?",
      "needed": "Review summary/criteria, original values/units, new materials and user decisions",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete prior content review connected?",
      "application_exception": "Do not invent current model/clinical review or completed publication from historical cross-checks or completed production.",
      "criterion": "Separate original information about Review summary/criteria, original values/units, new materials and user decisions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research addressing direct gaps in confirmed-infection incidence"
    }
  ]
}