{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2950-s0",
  "verdict_number": "2950",
  "title": "Lorcaserin × At least 5% weight loss at one year — Evidence sheet separating response, maintenance and cancer reanalysis",
  "view_version": "1.0",
  "view_created_date": "2026-10-11",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The stored summary was read for production and existing links were connected. Original papers, reviews, registrations, protocols, SAPs and regulatory communications were not separately read or checked.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "CAMELLIA participants with overweight or obesity; detailed eligibility and baseline-risk scope unread",
    "intervention": "Study of long-term lorcaserin use; not current usage instructions",
    "dose": "No specific dose, formulation or adherence information in the source; no medication instructions created",
    "comparator": "Placebo in CAMELLIA and BLOOM; Wadden compares maintenance after weight loss with a low-calorie diet",
    "endpoint": "At least 5% weight loss at one year; MACE, MACE+ and cancer are separate endpoints",
    "duration": "Selected duration: one year; CAMELLIA median follow-up 3.3 years; BLOOM 52 weeks and maintenance-trial 24 and 52 weeks separated",
    "excluded_extensions": [
      "Converting the one-year response to clinical-event or survival benefits",
      "Repurposing cardiovascular noninferiority as cancer safety",
      "Converting an FDA regulatory decision to new statistical certification of overall cancer results",
      "Medication, product or treatment instructions"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Are the selected one-year 5% response and the parent long-term weight verdict distinguished?",
      "needed": "Separate records of the subclaim, verdict and parent context",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of the subclaim, verdict and parent context",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If additional evidence is linked, incorporate it with the subclaim distinguished from the parent long-term and safety context.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The subclaim is “At least 5% weight loss at one year”, with original grade C and a note of 38.7% versus 17.4%, P<0.001. The parent has grade C, 50 points and a safety warning.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.",
      "missingness": "No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Are the actual participants and recruitment scope for the one-year response question preserved?",
      "needed": "Original eligibility, baseline risk and denominator material for participants with obesity or overweight",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original eligibility, baseline risk and denominator material for participants with obesity or overweight",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original tables of trial eligibility, baseline characteristics and the one-year analysis population.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The CAMELLIA citation identifies participants with overweight or obesity, and the stored summary records 12,000 randomized participants.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.",
      "missingness": "Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What were the study intervention, placebo, accompanying care and actual exposure?",
      "needed": "Study records of the original formulation, dose, exposure, placebo and lifestyle care",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Study records of the original formulation, dose, exposure, placebo and lifestyle care",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve actual intervention, placebo, exposure and accompanying-care material from the original protocol.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original intervention is long-term lorcaserin use, and CAMELLIA is double-blind and placebo-controlled. The drug is recorded as a serotonin 2C receptor agonist for weight loss.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.",
      "missingness": "Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are the one-year response definition of at least 5% and its measurement unit directly specified?",
      "needed": "Original material on baseline weight, measurement time, response determination and analysis unit",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original material on baseline weight, measurement time, response determination and analysis unit",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the response definition and measurement times from the original report and protocol.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original endpoint is “At least 5% weight loss at one year”. The subclaim note and weight response in the CAMELLIA evidence list correspond to the same question.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.",
      "missingness": "The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are the randomization denominator and the one-year response analysis denominator the same information?",
      "needed": "Arm-specific denominators for allocation, analysis, attrition and missing data",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific denominators for allocation, analysis, attrition and missing data",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original one-year arm-specific analysis populations, observed participant counts, responders and missing-data handling.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CAMELLIA allocated 12,000 participants in groups of 6,000, with median follow-up of 3.3 years.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.",
      "missingness": "The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "Are 38.7% versus 17.4% and the P value preserved as originally recorded?",
      "needed": "Original arm-specific one-year response percentages, between-group effects, CIs and tests",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original arm-specific one-year response percentages, between-group effects, CIs and tests",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the original between-group estimates, CIs, tests and analysis denominators when supplied.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CAMELLIA records at least 5% weight loss at one year as 38.7% versus 17.4%, P<0.001.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.",
      "missingness": "No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are the prespecified weight-response hierarchy and the primary cardiovascular design distinguished?",
      "needed": "Weight-endpoint prespecification, testing hierarchy and multiplicity plan",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Weight-endpoint prespecification, testing hierarchy and multiplicity plan",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the position and testing order of the weight endpoint in the registration, protocol and SAP.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CAMELLIA is designed as a randomized cardiovascular noninferiority trial; the stored summary records MACE safety and MACE+ efficacy as primary endpoints.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.",
      "missingness": "The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are randomization, blinding and outcome-analysis procedures preserved?",
      "needed": "Original records of allocation concealment, blinding, analysts and measurement methods",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original records of allocation concealment, blinding, analysts and measurement methods",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original methods, analysis plan, analysis populations and procedures.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The source explicitly describes CAMELLIA as a multicenter, double-blind, placebo-controlled randomized trial.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.",
      "missingness": "Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Can the relationship of one-year missing data, discontinuation and adherence to the effect be directly checked?",
      "needed": "Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original CAMELLIA one-year observation, discontinuation, missing-data handling and sensitivity-analysis tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "CAMELLIA randomization counts and median follow-up are available, but details of attrition, adherence and alternative analyses for the one-year response are absent from this summary.",
      "condition_status": "Unverified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.",
      "missingness": "BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Is the BLOOM 52-week response distinguished from repeated measurements in the same trial?",
      "needed": "Each trial’s identity, participants, comparison, time point and denominator",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Each trial’s identity, participants, comparison, time point and denominator",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link each trial’s 52-week or one-year definition, denominator, intervention and participants separately.",
      "current_reports": [
        "R03"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "BLOOM is a randomized placebo-controlled trial of 3,182 participants, recording at least 5% weight loss at 52 weeks as 47.5% versus 20.3%. It is a separate trial report from CAMELLIA.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.",
      "missingness": "The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are BLOOM’s low retention and the response analysis denominator distinguished?",
      "needed": "Original arm-specific retention, analysis and missing-data material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original arm-specific retention, analysis and missing-data material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original report’s analysis populations, missing-data handling, sensitivity analyses and responder tables.",
      "current_reports": [
        "R03"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "BLOOM one-year retention is 55.4% (883/1595) versus 45.1% (716/1587).",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.",
      "missingness": "Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are the weight trials independent replications with different funding sources and research teams?",
      "needed": "Original links among trials, development programs, funding and author overlap",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original links among trials, development programs, funding and author overlap",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve original funding, team and analysis-role material separately; connect any verdict update to a user decision.",
      "current_reports": [
        "R01",
        "R03"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary states that BLOOM and CAMELLIA share a developer program with overlapping funding and authors, are not independent replications, and retain the existing R1 assessment axis.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.",
      "missingness": "Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Does the maintenance trial after a low-calorie diet use the same comparison as the initial one-year response question?",
      "needed": "Weight-loss entry conditions, maintenance intervention, comparison and denominator",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Weight-loss entry conditions, maintenance intervention, comparison and denominator",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original entry weight loss, maintenance definitions, selected participants, arm-specific denominators and counseling/intervention components.",
      "current_reports": [
        "R04"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The Wadden maintenance trial randomized 137 participants who had lost at least 5% through a low-calorie diet. Its selection conditions differ from the initial weight-loss response question.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.",
      "missingness": "The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Are the maintenance trial’s 24-week results and 52-week co-primary results separated?",
      "needed": "Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original estimates and CIs, missing-data handling and multiplicity plans for each co-primary endpoint and time point.",
      "current_reports": [
        "R04"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "At 24 weeks, at least 5% maintenance was 73.9% versus 57.4% (P=0.033), with additional −2.4±0.8 kg versus +0.6±0.8 kg (P=0.010). Both 52-week co-primary results are recorded as showing no between-group difference.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.",
      "missingness": "Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Has weight loss avoided being extended to prevention of clinical cardiovascular events?",
      "needed": "Separate direct results for the weight surrogate and clinical events",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate direct results for the weight surrogate and clinical events",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link direct definitions, effects, CIs and follow-up for each clinical-event outcome as separate questions.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary records weight as a surrogate for clinical events and states that MACE+ superiority was null.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.",
      "missingness": "The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety."
    },
    {
      "item_id": "N16",
      "question_type": "Supplementary harm evidence",
      "question": "Are MACE safety noninferiority, weight efficacy and cancer safety distinguished?",
      "needed": "Original endpoint-specific prespecified margins, estimates, events and follow-up",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original endpoint-specific prespecified margins, estimates, events and follow-up",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the MACE noninferiority plan and direct material for other harm endpoints separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "MACE was 364 participants (6.1%) versus 369 (6.2%), HR 0.99 (95% CI 0.85~1.14), recorded as meeting the prespecified noninferiority margin of HR 1.40.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. These values are not weight-response effects or CIs and do not substitute for cancer safety.",
      "missingness": "These values are not weight-response effects or CIs and do not substitute for cancer safety.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "These values are not weight-response effects or CIs and do not substitute for cancer safety."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Has null MACE+ superiority avoided being converted to a null weight response?",
      "needed": "Events, estimates and tests for distinct efficacy endpoints",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Events, estimates and tests for distinct efficacy endpoints",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link endpoint definitions, the prespecified superiority plan and the weight-response hierarchy using original material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "MACE+ is recorded as 707 participants (11.8%) versus 727 (12.1%), HR 0.97 (0.87~1.07), P=0.55.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.",
      "missingness": "Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are manufacturer support, affiliated authors, design and manuscript roles separated?",
      "needed": "Separate records of cash funding, product provision, employee authors and external analysis roles",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of cash funding, product provision, employee authors and external analysis roles",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original disclosures of funding, products, affiliations, data access, analysis and manuscript roles separately.",
      "current_reports": [
        "R01",
        "R03"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Full Eisai funding, company-affiliated authors, and sponsor participation in co-design and manuscript preparation are recorded. Funding and author overlap with BLOOM is also preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.",
      "missingness": "Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Has the maintenance trial’s funding label avoided being converted to certification of a specific sponsor?",
      "needed": "Actual maintenance-trial funding, product, author and analysis records",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Actual maintenance-trial funding, product, author and analysis records",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the maintenance trial’s originally disclosed interests and research roles for each source.",
      "current_reports": [
        "R04"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The Wadden evidence-list funding entry is preserved only as “reported in the original text”.",
      "condition_status": "Unverified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.",
      "missingness": "This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Do the FDA cancer reanalysis and CAMELLIA efficacy report concern the same trial data?",
      "needed": "Relationships among the original trial, completed reanalysis, regulatory documents and paper reports",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Relationships among the original trial, completed reanalysis, regulatory documents and paper reports",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link completed reanalysis material and the result sources for each report.",
      "current_reports": [
        "R01",
        "R02",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The 2020 FDA reanalysis is recorded as concerning the same 12,000 CAMELLIA participants. The FDA review paper and FDA safety communication are linked as separate report entries.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.",
      "missingness": "The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Are people diagnosed with cancer, primary cancers and patient-years preserved as different units?",
      "needed": "Original harm-event definitions, people, tumors, observation time and denominators",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original harm-event definitions, people, tumors, observation time and denominators",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original tables of cancer-event definitions, repeated primary cancers, exposure time and denominators.",
      "current_reports": [
        "R02",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The FDA summary records 462 lorcaserin participants (7.7%, 520 primary cancers) versus 423 placebo participants (7.1%, 470 cancers), with approximately one additional cancer per 470 patient-years.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.",
      "missingness": "People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Are cancer-signal timing, cancer types and statistical confirmation distinguished?",
      "needed": "Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link completed event tables, prespecified plans, duration-specific estimates and the basis for regulatory decisions separately.",
      "current_reports": [
        "R02",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary records a widening difference over time, with imbalances in pancreatic, colorectal and lung cancers contributing. It states that the public FDA communication did not supply an overall cancer risk ratio, CI or P value.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.",
      "missingness": "The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Are a prespecified clinical cancer threshold and the weight-response threshold the same?",
      "needed": "Prespecified importance and analysis plans for each efficacy and harm endpoint",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Prespecified importance and analysis plans for each efficacy and harm endpoint",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve the plans and importance judgments for cancer and weight separately.",
      "current_reports": [
        "R01",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary records no declared prespecified clinical cancer threshold. The 5% threshold is the selected weight-response definition.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.",
      "missingness": "The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Are the market-withdrawal record and efficacy grade preserved together?",
      "needed": "Separate records of regulatory-event dates, scope, decisions and clinical efficacy",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of regulatory-event dates, scope, decisions and clinical efficacy",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If new regulatory material is supplied, link its original text, date and change event separately.",
      "current_reports": [
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved summary records the FDA request for voluntary withdrawal on February 13, 2020 and Eisai’s US market withdrawal, and explicitly states that weight grade C and 50 points do not mean that the drug is okay to take.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.",
      "missingness": "Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Have withdrawal reasons for other serotonergic drugs avoided being repurposed?",
      "needed": "Direct distinctions among drug-specific efficacy, harms and regulatory events",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Direct distinctions among drug-specific efficacy, harms and regulatory events",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If direct drug-specific material is supplied, link it with questions, participants and endpoints separated.",
      "current_reports": [
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary explains that fenfluramine valvulopathy, sibutramine cardiovascular harms and rimonabant psychiatric harms differ from the reason for lorcaserin withdrawal.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.",
      "missingness": "Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values."
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain for other harms, discontinuation and long-term exposure?",
      "needed": "Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Original safety collection, arm-specific events, discontinuation, exposure and long-term material are needed.",
      "current_reports": [
        "R01",
        "R02",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The parent safety status is Warning, and the preserved explanation focuses on cancer reanalysis and MACE.",
      "condition_status": "Unverified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.",
      "missingness": "Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe."
    },
    {
      "item_id": "N27",
      "question_type": "Supplementary harm evidence",
      "question": "Are the scope of safety reanalysis and independent harm replication distinguished?",
      "needed": "Relationships between reanalysis of the same trial and independent external harm material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Relationships between reanalysis of the same trial and independent external harm material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If external harm material is supplied, link trial, exposure, population and denominator relationships separately.",
      "current_reports": [
        "R01",
        "R02",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary explicitly states that the FDA reanalysis is a safety review of the same CAMELLIA trial and is not counted as a separate efficacy trial.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Other harm replication or incidence material was not looked up, and independence was not established, in this production.",
      "missingness": "Other harm replication or incidence material was not looked up, and independence was not established, in this production.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Other harm replication or incidence material was not looked up, and independence was not established, in this production."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Are citation URLs, no-abstract labels and unread full text distinguished?",
      "needed": "Separate actual-access records for papers, regulatory documents and stored summaries",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate actual-access records for papers, regulatory documents and stored summaries",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link originals obtained by the user for each source and record actual access status.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Five citation URLs are linked as preserved in the source. The original flag for FDA review paper PMID 32905671 is “no abstract; do not guess content”. All external sources remain unread in this production.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.",
      "missingness": "A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper."
    },
    {
      "item_id": "N29",
      "question_type": "Comparative efficacy",
      "question": "Are registration identifiers and reading of registrations, protocols and SAPs separated?",
      "needed": "Directly preserved registration, protocol and SAP material for each trial",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Directly preserved registration, protocol and SAP material for each trial",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If original registrations, protocols and SAPs are supplied, link them to each trial.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The CAMELLIA and FDA reanalysis evidence-list identifiers are both NCT02019264. The original registration-identifier values for BLOOM and the maintenance trial are “not applicable”.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.",
      "missingness": "No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists."
    },
    {
      "item_id": "N30",
      "question_type": "Comparative efficacy",
      "question": "Are the reference date, corrections, Korean and English manuscripts and parent axes preserved in their original form?",
      "needed": "Original verdict, language-specific wording, reference date and correction history",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original verdict, language-specific wording, reference date and correction history",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If new material arises, link preservation of the original text and a separate update event to review of the existing content.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The full stored-summary copy preserves the reference date 2026-08-26, empty correction history, Korean and English manuscripts, parent grade C, 50 points, Warning and original assessment axes.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.",
      "missingness": "The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review."
    },
    {
      "item_id": "N31",
      "question_type": "Comparative efficacy",
      "question": "Has the selected response avoided being extended to all long-term weight loss, maintenance or clinical function?",
      "needed": "Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link participants, comparators, time points, effects and harms suited to each long-term question separately.",
      "current_reports": [
        "R01",
        "R03",
        "R04"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The stored summary records inconsistent long-term maintenance results and weight as a surrogate in the context of the parent grade C verdict.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.",
      "missingness": "The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created."
    },
    {
      "item_id": "N32",
      "question_type": "Comparative efficacy",
      "question": "Are production completion, review of the existing content and independence certification separated?",
      "needed": "Separate records of original candidate history, production status and review status",
      "role": "Supplementary",
      "role_reason": "Supplementary condition separating production status and scope of application",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of original candidate history, production status and review status",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Incorporate only the user’s subsequent material or decisions as separate events.",
      "current_reports": [
        "R01",
        "R02",
        "R03",
        "R04",
        "R05"
      ],
      "existence": "Material information linked to the stored summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The current label is review of the existing content; active pending and completion flags for model/content/boundary are false. Original candidate-review pending and production-permitted labels are preserved as history.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.",
      "missingness": "No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.",
      "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Bohula EA, Wiviott SD, McGuire DK, et al. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018;379:1107-1117. PMID: 30145941.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/30145941/",
      "report_type": "Trial report",
      "existence": "Identifiers preserved in the original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "5% weight loss: 38.7% versus 17.4%, P<0.001; MACE HR 0.99 (0.85~1.14); MACE+ HR 0.97 (0.87~1.07), P=0.55",
      "result_level": "Preserved review summary; not a result of actually reading external papers or communications",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent summary"
        },
        {
          "material_type": "abstract",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/30145941/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "Sharretts J, Galescu O, Gomatam S, et al. Cancer Risk Associated with Lorcaserin—The FDA's Review of the CAMELLIA-TIMI 61 Trial. N Engl J Med. 2020;383:1000-1002. PMID: 32905671.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/32905671/",
      "report_type": "Regulatory reanalysis report",
      "existence": "Identifiers preserved in the original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "462 participants (7.7%, 520 cancers) versus 423 (7.1%, 470 cancers); approximately one additional cancer per 470 patient-years, with a widening difference over time",
      "result_level": "The evidence-list entry for FDA reanalysis of the same trial is linked as relational context; the original no-abstract label is preserved and the paper’s full-text results are not certified",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent summary"
        },
        {
          "material_type": "abstract",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/32905671/"
        }
      ]
    },
    {
      "report_id": "R03",
      "title": "Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010. PMID: 20647200.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/20647200/",
      "report_type": "Trial report",
      "existence": "Identifiers preserved in the original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F02",
      "independent_replication": false,
      "observed_result": "47.5% versus 20.3%; one-year retention 55.4% (883/1595) versus 45.1% (716/1587)",
      "result_level": "Preserved review summary; not a result of actually reading external papers or communications",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent summary"
        },
        {
          "material_type": "abstract",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/20647200/"
        }
      ]
    },
    {
      "report_id": "R04",
      "title": "Wadden TA, Walsh OA, Berkowitz RI, et al. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss…. PMID: 29288545.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/29288545/",
      "report_type": "Trial report",
      "existence": "Identifiers preserved in the original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F03",
      "independent_replication": false,
      "observed_result": "At 24 weeks, at least 5% maintenance: 73.9% versus 57.4% (P=0.033), additional −2.4±0.8 kg versus +0.6±0.8 kg (P=0.010); both 52-week co-primary results show no between-group difference",
      "result_level": "Preserved review summary; not a result of actually reading external papers or communications",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent summary"
        },
        {
          "material_type": "abstract",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/29288545/"
        }
      ]
    },
    {
      "report_id": "R05",
      "title": "US Food and Drug Administration. FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. February 13, 2020.",
      "url": "https://www.fda.gov/media/135189/download",
      "report_type": "Regulatory communication",
      "existence": "Identifiers preserved in the original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "462 participants (7.7%, 520 cancers) versus 423 (7.1%, 470 cancers); approximately one additional cancer per 470 patient-years, with a widening difference over time",
      "result_level": "Regulatory context preserved in the FDA reanalysis evidence list and existing review summary; not direct reading of the communication in this production",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent summary"
        },
        {
          "material_type": "abstract",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "fulltext",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review"
        }
      ],
      "links": [
        {
          "label": "Official source",
          "url": "https://www.fda.gov/media/135189/download"
        }
      ]
    }
  ],
  "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count."
  },
  "history": [
    {
      "date": "2026-10-11",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-11"
}