{
  "schema_name": "soa-table-extraction",
  "schema_version": "1.0",
  "extraction_metadata": {
    "extracted_at": "2026-09-27T12:58:17+00:00",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT04184622_soa.pdf",
      "document_type": "protocol",
      "document_version": "I8F-MC-GPHK(b)"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "All printed '*' markers in this table point to the 'Additional Information Regarding Activities Described in Schedule of Activities' table printed after Table 2 (document pages 25-28), per the source note '*Please see table below for corresponding additional information'. Because every marker prints as the same '*', each Additional Information note was given a synthesized id (n1..n27, identical across Tables 1 and 2) and bound to the starred element whose label matches that note's Activity cell (method text_match). The Additional Information table itself is not emitted as a table (its rows key to SoA elements; soa_table_type_definitions 'reference' rule). Abbreviation lists dropped (no in-grid abbreviation markers). Grid read by pdftotext -bbox column binning to Visit-row centres; row bands from raster rule lines.",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_number": 2,
    "table_type": "track",
    "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization",
    "table_purpose": "Additional 2-year treatment period (Weeks 78-176, Visits 101-116, 199, ED, 802) for participants with prediabetes at randomization only.",
    "page_start": 22,
    "page_end": 24,
    "track_label": "Prediabetes",
    "notes": "Classified track, not domain/continuation: section 1.3.2 is its own numbered schedule with different visits (101-116, 199, ED, 802) and weeks (78-176), and it applies only to the sub-population with prediabetes at randomization (a separate study phase for a subset of participants)."
  },
  "schedule_properties": [
    {
      "table_number": 2,
      "row_position": 1,
      "property_name": "Visit",
      "property_name_source": {
        "row_position": 1,
        "column_position": 1,
        "cell_value": "Visit*"
      },
      "property_type": "visit",
      "property_comment": "Visit identifiers (1–21, 99, ED, 801 in Table 1; 101–116, 199, ED, 802 in Table 2); a named/numbered visit per column, so property_type visit. Uniquely identifies every column.",
      "hierarchical_level": 1,
      "annotation_markers": "n1"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "property_name": "Week of Treatment",
      "property_name_source": {
        "row_position": 2,
        "column_position": 1,
        "cell_value": "Week of Treatment"
      },
      "property_type": "week",
      "property_comment": "Week of treatment relative to randomization (negative weeks = screening/lead-in; last column reads \"N wks Post TxP\"). Numeric week labels, so property_type week. ED column is empty.",
      "hierarchical_level": 2
    },
    {
      "table_number": 2,
      "row_position": 3,
      "property_name": "Allowable Deviation (days)",
      "property_name_source": {
        "row_position": 3,
        "column_position": 1,
        "cell_value": "Allowable Deviation (days)*"
      },
      "property_type": "window",
      "property_comment": "Visit window in days (±3, +7, ±7). Allowed deviation around the target date, so property_type window. Empty for the first visit and for ED.",
      "hierarchical_level": 3,
      "annotation_markers": "n6"
    },
    {
      "table_number": 2,
      "row_position": 4,
      "property_name": "Fasting Visit",
      "property_name_source": {
        "row_position": 4,
        "column_position": 1,
        "cell_value": "Fasting Visit*"
      },
      "property_type": "other",
      "property_comment": "X marks visits at which the participant must attend fasting. A per-visit attribute/requirement flag, not a timing level; does not distinguish columns, so hierarchical_level null and property_type other.",
      "hierarchical_level": null,
      "structure_method": "inferred_from_layout",
      "annotation_markers": "n1"
    },
    {
      "table_number": 2,
      "row_position": 5,
      "property_name": "Telephone Visit",
      "property_name_source": {
        "row_position": 5,
        "column_position": 1,
        "cell_value": "Telephone Visit"
      },
      "property_type": "modality",
      "property_comment": "X marks visits conducted by telephone (these columns are grey-shaded in the body). Visit type/modality, so property_type modality; does not distinguish columns, so hierarchical_level null.",
      "hierarchical_level": null,
      "structure_method": "inferred_from_layout"
    }
  ],
  "schedule_grid": [
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 2,
      "cell_value": "101"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 3,
      "cell_value": "102"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 4,
      "cell_value": "103"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 5,
      "cell_value": "104"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 6,
      "cell_value": "105"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 7,
      "cell_value": "106"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 8,
      "cell_value": "107"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 9,
      "cell_value": "108"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 10,
      "cell_value": "109"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 11,
      "cell_value": "110"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 12,
      "cell_value": "111"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 13,
      "cell_value": "112"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 14,
      "cell_value": "113"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 15,
      "cell_value": "114"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 16,
      "cell_value": "115"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 17,
      "cell_value": "116"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 18,
      "cell_value": "199",
      "annotation_markers": "n3"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 19,
      "cell_value": "ED",
      "annotation_markers": "n4"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 20,
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      "annotation_markers": "n5"
    },
    {
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      "row_position": 2,
      "column_position": 2,
      "cell_value": "78"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 3,
      "cell_value": "85"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 4,
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    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 5,
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    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 6,
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    },
    {
      "table_number": 2,
      "row_position": 2,
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      "cell_value": "111"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 8,
      "cell_value": "117"
    },
    {
      "table_number": 2,
      "row_position": 2,
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    },
    {
      "table_number": 2,
      "row_position": 2,
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    },
    {
      "table_number": 2,
      "row_position": 2,
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    },
    {
      "table_number": 2,
      "row_position": 2,
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    },
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      "table_number": 2,
      "row_position": 2,
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      "cell_value": "150"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 14,
      "cell_value": "156"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 15,
      "cell_value": "163"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 16,
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    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 17,
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    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 18,
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    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 19,
      "cell_value": ""
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 20,
      "cell_value": "17 wks Post TxP"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 2,
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    },
    {
      "table_number": 2,
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    },
    {
      "table_number": 2,
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    {
      "table_number": 2,
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    },
    {
      "table_number": 2,
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    },
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      "table_number": 2,
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    },
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    },
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      "table_number": 2,
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    },
    {
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      "table_number": 2,
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    },
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    },
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      "table_number": 2,
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    {
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      "table_number": 2,
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    },
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      "table_number": 2,
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      "table_number": 2,
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    },
    {
      "table_number": 2,
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    },
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      "table_number": 2,
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    },
    {
      "table_number": 2,
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    }
  ],
  "activities": [
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      "table_number": 2,
      "row_position": 6,
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      "activity_name": "Register study visit in IWRS",
      "activity_name_source": {
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        "indentation_level": 0,
        "indentation_method": "visual_estimate"
      }
    },
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      "table_number": 2,
      "row_position": 7,
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        "cell_text": "Clinical Assessments",
        "indentation_level": 0,
        "indentation_method": "visual_estimate"
      }
    },
    {
      "table_number": 2,
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      "activity_name": "Weight",
      "activity_name_source": {
        "cell_text": "Weight*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n8"
    },
    {
      "table_number": 2,
      "row_position": 9,
      "source_page": 22,
      "activity_name": "Waist circumference",
      "activity_name_source": {
        "cell_text": "Waist circumference",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      }
    },
    {
      "table_number": 2,
      "row_position": 10,
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      "activity_name": "Electrocardiogram",
      "activity_name_source": {
        "cell_text": "Electrocardiogram*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n9"
    },
    {
      "table_number": 2,
      "row_position": 11,
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      "activity_name": "Vital signs (3 sitting BP and HR)",
      "activity_name_source": {
        "cell_text": "Vital signs (3 sitting BP and HR)*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n10"
    },
    {
      "table_number": 2,
      "row_position": 12,
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        "indentation_method": "visual_estimate"
      }
    },
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      "table_number": 2,
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      "activity_name_source": {
        "cell_text": "Concomitant medications",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      }
    },
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      "activity_name_source": {
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        "indentation_method": "visual_estimate"
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    },
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      "activity_name": "Hand out diary, instruct in use",
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        "cell_text": "Hand out diary, instruct in use*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n11"
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        "cell_text": "Review study participant diary, including study drug compliance *",
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        "indentation_method": "visual_estimate"
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      "activity_name": "Lifestyle Program instructions",
      "activity_name_source": {
        "cell_text": "Lifestyle Program instructions*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n13"
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      "table_number": 2,
      "row_position": 18,
      "source_page": 22,
      "activity_name": "Review diet and exercise goals",
      "activity_name_source": {
        "cell_text": "Review diet and exercise goals*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "n14"
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      "table_number": 2,
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      "activity_name": "Dispense study drug",
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        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      }
    },
    {
      "table_number": 2,
      "row_position": 20,
      "source_page": 23,
      "activity_name": "Participant returns study drugs and injection supplies",
      "activity_name_source": {
        "cell_text": "Participant returns study drugs and injection supplies",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      }
    },
    {
      "table_number": 2,
      "row_position": 21,
      "source_page": 23,
      "activity_name": "Laboratory Tests",
      "activity_name_source": {
        "cell_text": "Laboratory Tests",
        "indentation_level": 0,
        "indentation_method": "visual_estimate"
      }
    },
    {
      "table_number": 2,
      "row_position": 22,
      "source_page": 23,
      "activity_name": "Urine pregnancy test",
      "activity_name_source": {
        "cell_text": "Urine pregnancy test*",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
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  ],
  "annotations": [
    {
      "annotation_marker": "n1",
      "annotation_type": "footnote",
      "annotation_text": "On all office visits, study participants should be reminded to report to the site before taking study drug (s) in a fasting condition, after a period of approximately 8 hours without eating, drinking (except water), or any significant physical activity. Since some screening procedures need to be completed in the fasting state, Visit 1 may be conducted over more than 1 day to ensure necessary conditions are met.",
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      ]
    },
    {
      "annotation_marker": "n3",
      "annotation_type": "footnote",
      "annotation_text": "Participants wanting to discontinue the study before Week 72 will be asked to return for Visit 99 at 72 weeks ± 7 days after randomization primarily for body weight measurement and assessment of adverse events. If the participant is unwilling to attend Visit 99, it should be documented in the participant medical record that the participant has refused to attend. Participants wanting to discontinue the study after Week 72 but before Week 176 will be asked to return for Visit 199 primarily for the body weight measurement and assessment of adverse events. Refusal to attend should be documented.",
      "marker_locations": [
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          "table_number": 2,
          "location_type": "schedule_cell",
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      ]
    },
    {
      "annotation_marker": "n4",
      "annotation_type": "footnote",
      "annotation_text": "Participants who are unable or unwilling to continue the study treatment for any reason will perform an ED visit. If the participant is discontinuing during an unscheduled visit or a scheduled visit, that visit should be performed as the ED visit.",
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        {
          "table_number": 2,
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        }
      ]
    },
    {
      "annotation_marker": "n5",
      "annotation_type": "footnote",
      "annotation_text": "For participants who discontinue or complete the study within the first 72 weeks, Visit 801 (safety follow-up visit) should be performed 4 weeks after the last visit during the 72-week treatment period. Participants with prediabetes continuing to Week 78 should not perform Visit 801. For participants with prediabetes who complete the 176 weeks or discontinue after Week 72, Visit 802 should be performed 17 weeks after the last visit during the additional 2-year treatment period for participants with prediabetes at randomization.",
      "marker_locations": [
        {
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          "location_type": "schedule_cell",
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      ]
    },
    {
      "annotation_marker": "n6",
      "annotation_type": "footnote",
      "annotation_text": "The visit date is determined in relation to the date of the randomization visit (± the allowed visit window).",
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          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n8",
      "annotation_type": "footnote",
      "annotation_text": "Weight measurements should be obtained per the instructions in Section 10.7. Body weight must be measured in fasting state. If the participant is not fasting, the participant should be called in for a new visit within the visit window to have the fasting body weight measured.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
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          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n9",
      "annotation_type": "footnote",
      "annotation_text": "ECG measurements should be obtained per the instructions in Section 10.7. ECGs will be performed in triplicate at Weeks 0 and 36. All other ECGs will be single measurements. ECGs should be collected at least 30 minutes prior to collection of blood samples for laboratory testing, including PK samples.",
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        {
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          "location_type": "activity_name",
          "row_position": 10,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n10",
      "annotation_type": "footnote",
      "annotation_text": "Vital-sign measurements should be taken before obtaining an ECG tracing and before collection of blood samples for laboratory testing, per the instruction in Section 10.7.",
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          "row_position": 11,
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        }
      ]
    },
    {
      "annotation_marker": "n11",
      "annotation_type": "footnote",
      "annotation_text": "All training should be repeated as needed to ensure participant compliance.",
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          "row_position": 15,
          "method": "text_match"
        }
      ]
    },
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      "annotation_marker": "n12",
      "annotation_type": "footnote",
      "annotation_text": "Data from diary, as well as study drug compliance, should be reviewed.",
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          "row_position": 16,
          "method": "text_match"
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      ]
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    {
      "annotation_marker": "n13",
      "annotation_type": "footnote",
      "annotation_text": "Counselling on diet and exercise, to be performed by a dietician or equivalent qualified delegate, to include calculation of individualized energy requirement and methods to change dietary composition and amount of physical activity. The Lifestyle Program Instruction may be delivered on a separate day from the rest of that visit’s study procedures but must occur within the visit window. Beginning at Week 8, the Lifestyle Program Instruction may be delivered by phone.",
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          "location_type": "activity_name",
          "row_position": 17,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n14",
      "annotation_type": "footnote",
      "annotation_text": "All training should be repeated as needed to ensure participant compliance. Study personnel to provide reinforcement and encouragement for lifestyle modifications.",
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        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 18,
          "method": "text_match"
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      ]
    },
    {
      "annotation_marker": "n19",
      "annotation_type": "footnote",
      "annotation_text": "A urine pregnancy test must be performed at Visit 3 with the result available prior to randomization and first injection of study drug(s) for women of childbearing potential only. Additional pregnancy tests (beyond those required per the Schedule of Activities) should be performed at any time during the trial if a menstrual period is missed, there is clinical suspicion of pregnancy, or as required by local law or regulation.",
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        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 22,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n21",
      "annotation_type": "footnote",
      "annotation_text": "2-hour OGTT testing should be omitted at visits following a protocol-defined diabetes diagnosis.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 23,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n23",
      "annotation_type": "footnote",
      "annotation_text": "The CKD-EPI equation will be used by the central lab to estimate and report eGFR.",
      "marker_locations": [
        {
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          "location_type": "activity_name",
          "row_position": 24,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n24",
      "annotation_type": "footnote",
      "annotation_text": "PK samples for immunogenicity must be taken prior to drug administration at these visits. In the event of systemic drug hypersensitivity reactions (immediate or nonimmediate), additional blood samples will be collected including ADA, PK, and exploratory biomarker samples.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 33,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n26",
      "annotation_type": "footnote",
      "annotation_text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed.",
      "marker_locations": [
        {
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          "location_type": "activity_name",
          "row_position": 36,
          "method": "text_match"
        },
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          "method": "text_match"
        },
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          "table_number": 2,
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          "row_position": 38,
          "method": "text_match"
        }
      ]
    },
    {
      "annotation_marker": "n27",
      "annotation_type": "footnote",
      "annotation_text": "Self-Harm Follow-up Form is only required if triggered by the Self-Harm Supplement Form, per instructions in the form.",
      "marker_locations": [
        {
          "table_number": 2,
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          "row_position": 39,
          "method": "text_match"
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      ]
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  ],
  "review_items": [
    {
      "id": "D6",
      "severity": "medium",
      "location": {
        "page": 22
      },
      "call_made": "Table 2 (section 1.3.2) is typed 'track' with label 'Prediabetes': a separate 2-year schedule (Visits 101-116, 199, ED, 802; Weeks 78-176) only for participants with prediabetes at randomization.",
      "alternative": "Type it 'main_soa' (an independent schedule with its own columns) rather than a population/phase track.",
      "report_section": "4.1"
    },
    {
      "id": "D7",
      "severity": "low",
      "location": {
        "page": 24,
        "row_position": 1
      },
      "call_made": "The line '*Please see table below for corresponding additional information' is not emitted as its own annotation; its content is carried by the 27 per-note annotations it points to.",
      "alternative": "Emit it as an additional source_note annotation with marker '*' attached at table level.",
      "report_section": "4.3"
    }
  ]
}
