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      "row_position": 17,
      "column_position": 7,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 18,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, 90 min"
    },
    {
      "table_number": 1,
      "row_position": 18,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, 90 min"
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, 90 min"
    },
    {
      "table_number": 1,
      "row_position": 19,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, 90 min"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, Predose, 15, 30, 60, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, Predose, 15, 30, 60, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 20,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 21,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction (30 and 15 min prior to insulin infusion), Predose, 15, 30, 60, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 22,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction (30 and 15 min prior to insulin infusion), Predose, 15, 30, 60, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 24,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 25,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 25,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction"
    },
    {
      "table_number": 1,
      "row_position": 25,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction"
    },
    {
      "table_number": 1,
      "row_position": 25,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 26,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 26,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction"
    },
    {
      "table_number": 1,
      "row_position": 27,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 27,
      "column_position": 3,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 27,
      "column_position": 6,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 27,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 28,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 29,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 30,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 31,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 31,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 31,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 31,
      "column_position": 9,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 32,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, -5, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 32,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, -5, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 min"
    },
    {
      "table_number": 1,
      "row_position": 33,
      "column_position": 3,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 34,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction"
    },
    {
      "table_number": 1,
      "row_position": 34,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 34,
      "column_position": 9,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 36,
      "column_position": 3,
      "cell_value": "X"
    },
    {
      "table_number": 1,
      "row_position": 37,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, 15, 30, 60, 120 min"
    },
    {
      "table_number": 1,
      "row_position": 37,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, 15, 30, 60, 120 min"
    },
    {
      "table_number": 1,
      "row_position": 38,
      "column_position": 4,
      "cell_value": "Pre-hypoglycemia induction, During hypoglycemia induction, Predose, 15, 30, 60, 120 min"
    },
    {
      "table_number": 1,
      "row_position": 38,
      "column_position": 7,
      "cell_value": "Pre-hypoglycemia induction, During hypoglycemia induction, Predose, 15, 30, 60, 120 min"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "a",
      "annotation_type": "footnote",
      "annotation_text": "Samples for immunogenicity, should be collected every 12 weeks (84±7 days) until the titer returns to baseline (ie, returns to within a single 2-fold dilution of the baseline titer) or until 1 year after the last dose of study treatment. A time-matched PK (glucagon) sample may be collected at the follow-up immunogenicity assessment(s) if warranted and agreed upon between both the investigator and sponsor.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 9
        }
      ]
    },
    {
      "annotation_marker": "c1",
      "annotation_type": "footnote",
      "annotation_text": "Admission can be rescheduled if PG level is not 90 to 250 mg/dL on Day 1.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 6,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c2",
      "annotation_type": "footnote",
      "annotation_text": "Patient may be discharged 6 hours after glucagon administration. A patient may remain inpatient at the CRU at the discretion of the investigator.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 7,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c3",
      "annotation_type": "footnote",
      "annotation_text": "After screening, medical assessment only performed to include medical review and targeted examination, as appropriate.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 10,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c4",
      "annotation_type": "footnote",
      "annotation_text": "Height is at screening only. Weight on Day 1 will be collected before the start of the procedure to induce hypoglycemia.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 11,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c5",
      "annotation_type": "source_note",
      "annotation_text": "Refer to Section 9.5.5.1.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 12,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c6",
      "annotation_type": "footnote",
      "annotation_text": "Review patients’ insulin regimens to confirm acceptability to undergo the procedure to induce hypoglycemia.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 13,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c7",
      "annotation_type": "footnote",
      "annotation_text": "After completion of all PK sampling, patients will be provided a carbohydrate-rich meal. The investigator will ensure the patient’s PG is stable. A prandial insulin dose will be administered if needed.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 14,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c8",
      "annotation_type": "footnote",
      "annotation_text": "Procedures in Period 2 will occur at approximately the same time as those in Period 1. Insulin infusion is stopped once bedside PG is <60 mg/dL.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 15,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c9",
      "annotation_type": "footnote",
      "annotation_text": "Samples will be collected during the hypoglycemia induction procedure and post study treatment (up to 120 mins). Bedside PG monitoring will be conducted no more than 10 minutes apart while bedside PG is ≥90 mg/dL and no more than 5 minutes apart when bedside PG is <90 mg/dL.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 16,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c10",
      "annotation_type": "footnote",
      "annotation_text": "Once bedside PG reaches <60 mg/dL, the insulin infusion is stopped and approximately 5 minutes later study drug is administered. Indicates Time = 0 min.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 17,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c11",
      "annotation_type": "footnote",
      "annotation_text": "Injection-site assessment for IMG only.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 18,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c12",
      "annotation_type": "footnote",
      "annotation_text": "Nasal inspection both for IMG and LY900018.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 19,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c13",
      "annotation_type": "footnote",
      "annotation_text": "Time points may be added for each period if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 20,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c14",
      "annotation_type": "footnote",
      "annotation_text": "Time points may be added for Period 1 and Period 2 if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 22,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c15",
      "annotation_type": "source_note",
      "annotation_text": "See Appendix 2, Clinical Laboratory Tests, for details.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 24,
          "method": "synthesized"
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 26,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c16",
      "annotation_type": "footnote",
      "annotation_text": "See Appendix 2, Clinical Laboratory Tests, for details. Patients do not need to fast for samples at screening or follow-up. At Periods 1 and 2, samples should be collected from patients who have fasted at least 8 hours before any study procedures.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 25,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c17",
      "annotation_type": "footnote",
      "annotation_text": "Serum pregnancy test will be performed at screening. Urine pregnancy test will be performed at every admission period and follow-up visit if applicable.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 27,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c18",
      "annotation_type": "footnote",
      "annotation_text": "When needed to confirm postmenopausal status.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 28,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c19",
      "annotation_type": "footnote",
      "annotation_text": "Additional tests can be done at the discretion of the investigator.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 29,
          "method": "synthesized"
        },
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 30,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c20",
      "annotation_type": "footnote",
      "annotation_text": "Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 31,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c21",
      "annotation_type": "footnote",
      "annotation_text": "-5 mins = stop insulin infusion. Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 32,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c22",
      "annotation_type": "footnote",
      "annotation_text": "Single sample for pharmacogenetic analysis taken prior to/on Period 1 Day -1.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 33,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c23",
      "annotation_type": "footnote",
      "annotation_text": "In the event of drug hypersensitivity reactions (immediate or non-immediate), samples will be collected as close to event onset as possible, at event resolution, and 30 days following the event. Patients with TE ADA at follow-up/ED will undergo additional follow-up. Refer to Section 9.7.1 for details.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 34,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c24",
      "annotation_type": "footnote",
      "annotation_text": "Sampling times are relative to the time of study treatment administration (0 min). Questionnaire will be collected in both LY900018 and IMG treatment groups in both periods.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 37,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "c25",
      "annotation_type": "footnote",
      "annotation_text": "Sampling times are relative to the time of study treatment administration (0 min). During hypoglycemia induction will be when PG ≤75 mg/dL. Predose time point will be between insulin infusion stop and study treatment.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "activity_name",
          "row_position": 38,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n1",
      "annotation_type": "footnote",
      "annotation_text": "Note: if multiple procedures take place at the same time point, the following order of the procedure should be used: ECG, vital signs, and venipuncture. Plasma glucose sample should be collected as close as possible of protocol-specified time point.",
      "marker_locations": [
        {
          "table_number": 1,
          "location_type": "schedule_property",
          "row_position": 1,
          "method": "synthesized"
        }
      ]
    }
  ],
  "review_items": [
    {
      "id": "D1",
      "severity": "medium",
      "location": {
        "page": 11,
        "row_position": 2
      },
      "call_made": "The second header row (label cell reads \"Procedure\") is recorded as a study-day row named \"Study Day\", although its washout and follow-up entries are a duration (\"3 to 14 days\") and a relative window (\"Within 28±2 days after last study treatment\").",
      "alternative": "Type the row as \"other\" (mixed day / duration / window content), or keep the printed label \"Procedure\" as its name.",
      "report_section": "3"
    },
    {
      "id": "D2",
      "severity": "low",
      "location": {
        "page": 18,
        "annotation_marker": "n1"
      },
      "call_made": "The unmarked \"Note: if multiple procedures take place at the same time point...\" below the table is kept as a table-wide footnote with a synthesised marker n1 anchored to the top header row.",
      "alternative": "Bind it to the activities it names (ECG, vital signs, venipuncture-based lab/PK/PG rows) instead of the whole table.",
      "report_section": "5"
    },
    {
      "id": "D3",
      "severity": "low",
      "location": {
        "page": 16,
        "row_positions": [
          31,
          32,
          33,
          34
        ]
      },
      "call_made": "PK (Glucagon), Plasma Glucose for PD, Genetic Sample (Stored) and Anti-glucagon Antibodies are indented as children of the \"Laboratory Tests\" section header (level 1), since no other section header precedes them.",
      "alternative": "Treat them as their own ungrouped rows; the source prints no separate header (e.g. \"PK/PD sampling\") for them.",
      "report_section": "4"
    }
  ]
}
