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      "source_range": ""
    },
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      "source_range": ""
    },
    {
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      "source_range": "",
      "annotation_markers": "14"
    },
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    },
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    {
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    {
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      "row_position": 20,
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      "source_range": "3:9",
      "annotation_markers": "15"
    },
    {
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      "row_position": 20,
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    },
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    },
    {
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    },
    {
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    },
    {
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    },
    {
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      "annotation_markers": "15"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "1",
      "annotation_type": "footnote",
      "annotation_text": "Treatment cycles are 28 days long, visits on Day 1 of each cycle unless otherwise specified.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 5
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 6
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 7
        }
      ]
    },
    {
      "annotation_marker": "2",
      "annotation_type": "footnote",
      "annotation_text": "Visits continue every 4 weeks until study treatment discontinuation.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 1,
          "column_position": 8
        }
      ]
    },
    {
      "annotation_marker": "3",
      "annotation_type": "footnote",
      "annotation_text": "Negative serum pregnancy test required within 72 hours prior to study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 7,
          "column_position": 2
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 7,
          "column_position": 5
        }
      ]
    },
    {
      "annotation_marker": "4",
      "annotation_type": "footnote",
      "annotation_text": "Patients will be randomized in a crossover design within 72 hours prior to FE Day 1 (first single dose).",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 8,
          "column_position": 2
        }
      ]
    },
    {
      "annotation_marker": "5",
      "annotation_type": "footnote",
      "annotation_text": "Patients receive a single oral dose of niraparib 300 mg on FE Days 1 and 8.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 9,
          "column_position": 3
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 9,
          "column_position": 4
        }
      ]
    },
    {
      "annotation_marker": "6",
      "annotation_type": "footnote",
      "annotation_text": "No new capsules dispensed.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 9,
          "column_position": 9
        }
      ]
    },
    {
      "annotation_marker": "7",
      "annotation_type": "footnote",
      "annotation_text": "Height obtained at screening only.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 12
        }
      ]
    },
    {
      "annotation_marker": "8",
      "annotation_type": "footnote",
      "annotation_text": "Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen and bilirubin.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 15
        }
      ]
    },
    {
      "annotation_marker": "9",
      "annotation_type": "footnote",
      "annotation_text": "12-lead ECG at Screening, Cycle 1/Day 1 (predose and 2 hours postdose), Cycle 2/Day 1 (predose and 2 hours postdose), and at treatment discontinuation. ECG monitoring is to be performed prior to PK blood draws.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 16
        }
      ]
    },
    {
      "annotation_marker": "10",
      "annotation_type": "footnote",
      "annotation_text": "Triplicate ECG monitoring to coincide with PK on FE Days 1 and 8 at baseline (predose) and at 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 16,
          "column_position": 3
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 16,
          "column_position": 4
        }
      ]
    },
    {
      "annotation_marker": "11",
      "annotation_type": "footnote",
      "annotation_text": "Blood samples for PK will be taken on FE Days 1 and 8 at baseline (within 30 minutes prior to dosing) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose. Additional blood samples will be collected predose and 2 hours postdose on Day 1 of Cycles 1 and 2 and predose only on Day 1 of Cycles 4 and 8. The exact time of the PK blood draw will be recorded and PK blood draws are to be completed after ECG monitoring.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 17
        }
      ]
    },
    {
      "annotation_marker": "14",
      "annotation_type": "footnote",
      "annotation_text": "SAEs recorded up to 30 days after study treatment discontinuation.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 18,
          "column_position": 9
        }
      ]
    },
    {
      "annotation_marker": "15",
      "annotation_type": "footnote",
      "annotation_text": "For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria²⁰) and other sample testing results related to MDS/AML.",
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        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 3
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 4
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 5
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 6
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 7
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 8
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 20,
          "column_position": 9
        }
      ]
    },
    {
      "annotation_marker": "n1",
      "annotation_type": "footnote",
      "annotation_text": "Note: Patients in food effect sub-study will receive a single oral dose of niraparib 300 mg on FE Days 1 and 8. Upon completion of the 14-day sub-study, patients will then start open-label treatment with daily niraparib (300 mg QD) on Day 1/Cycle 1 (approximately 2 weeks after start of food effect sub-study) and will be followed using the main study visit schedule for safety.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1
        }
      ]
    }
  ],
  "review_items": [
    {
      "id": "D3",
      "severity": "medium",
      "location": {
        "page": 72
      },
      "call_made": "Printed Table 8 is typed as a separate track ('Food Effect Sub-Study'): it schedules the food-effect sub-study patients on their own visits (FE Day 1, FE Day 8).",
      "alternative": "Type it main_soa, as an independent schedule table of its own, without a track label.",
      "report_section": "3.1"
    },
    {
      "id": "D4",
      "severity": "low",
      "location": {
        "page": 73,
        "row_position": 1,
        "annotation_marker": "12"
      },
      "call_made": "On the reprinted header of page 73 the footnotes on 'Cycle' and 'Subsequent Cycles' are renumbered 12 and 13; their text is identical to footnotes 1 and 2, so the reprinted header is de-duplicated and 12/13 are not emitted as separate notes.",
      "alternative": "Emit footnotes 12 and 13 as their own notes on the same header cells, in addition to 1 and 2.",
      "report_section": "3.4"
    },
    {
      "id": "D5",
      "severity": "high",
      "location": {
        "page": 73,
        "row_position": 1,
        "annotation_marker": "n1"
      },
      "call_made": "The full-width 'Note: Patients in food effect sub-study ...' row at the foot of the page-73 table is not an activity; it is kept as one footnote (synthesised marker n1) applying to the whole table, anchored on header row 1.",
      "alternative": "Bind the note to specific rows (e.g. study treatment dispensed/collected) or leave its scope unresolved.",
      "report_section": "3.3"
    }
  ]
}