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  "protocol_id": "NCT05051579",
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    "consolidated_at": "2026-10-03T15:50:48.783667+00:00",
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        "column_count": 20,
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      "fuzzy_auto": 0,
      "fuzzy_cross_parent": 0,
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      "open": 0,
      "decided": 0,
      "near_matches": 0
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    "unified_activity_count": 71,
    "compression_percent": 0,
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      "deduplication_percent": 0,
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  ],
  "unified_annotations": [
    {
      "xannot_id": "xannot-001",
      "annotation_type": "footnote",
      "annotation_text": "For early terminations that occur before the last visit in treatment period, see the activities listed for ET in this table. Shaded columns represent the dose escalation period Weeks 0-16.",
      "display_markers": "T1:n1",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n1",
          "annotation_id": "annot-001"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [
        "xcol-003",
        "xcol-004",
        "xcol-005",
        "xcol-006",
        "xcol-007",
        "xcol-008",
        "xcol-009",
        "xcol-010",
        "xcol-011",
        "xcol-012",
        "xcol-013",
        "xcol-014",
        "xcol-015",
        "xcol-016",
        "xcol-017",
        "xcol-018"
      ],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-002",
      "annotation_type": "footnote",
      "annotation_text": "Vital signs include pulse rate, blood pressure, and temperature. Vital sign measurements should be collected after participant has been sitting for at least 5 minutes and before obtaining an ECG tracing and before collection of blood samples for laboratory testing (see Section 10.7).",
      "display_markers": "T1:n2",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n2",
          "annotation_id": "annot-002"
        }
      ],
      "referenced_xacts": [
        "xact-013"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "10.7"
        }
      ]
    },
    {
      "xannot_id": "xannot-003",
      "annotation_type": "footnote",
      "annotation_text": "As indicated based on participant status and standard of care. May be performed by qualified personnel per local regulations.",
      "display_markers": "T1:n3",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n3",
          "annotation_id": "annot-003"
        }
      ],
      "referenced_xacts": [
        "xact-015"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-004",
      "annotation_type": "footnote",
      "annotation_text": "Single central ECGs will be performed at screening and early termination. Central ECGs should be collected in triplicate at all other visits. ECG should be collected prior to collection of blood samples, including PK samples. ECG measurements should be obtained per the instructions in Section 8.2.3.",
      "display_markers": "T1:n4",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n4",
          "annotation_id": "annot-004"
        }
      ],
      "referenced_xacts": [
        "xact-016"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "8.2.3"
        }
      ]
    },
    {
      "xannot_id": "xannot-005",
      "annotation_type": "footnote",
      "annotation_text": "Participants should return the ABPM device at the conclusion of the 24- to 27-hour monitoring period.",
      "display_markers": "T1:n5",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n5",
          "annotation_id": "annot-005"
        }
      ],
      "referenced_xacts": [
        "xact-019"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-006",
      "annotation_type": "footnote",
      "annotation_text": "At the time participant visit data are uploaded by the site, the ABPM Data Validity Report will be generated and should be reviewed to ensure ≥70% of readings are valid. If <70% of readings are valid, the 24-hour monitoring session should be repeated within the visit window.",
      "display_markers": "T1:n6",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n6",
          "annotation_id": "annot-006"
        }
      ],
      "referenced_xacts": [
        "xact-020"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-007",
      "annotation_type": "footnote",
      "annotation_text": "May be performed more frequently based on usual site practices and participant needs.",
      "display_markers": "T1:n7",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n7",
          "annotation_id": "annot-007"
        }
      ],
      "referenced_xacts": [
        "xact-022"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-008",
      "annotation_type": "footnote",
      "annotation_text": "May be performed based on participant needs.",
      "display_markers": "T1:n8",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n8",
          "annotation_id": "annot-008"
        }
      ],
      "referenced_xacts": [
        "xact-023"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-009",
      "annotation_type": "footnote",
      "annotation_text": "The date and time of all dose administrations will be recorded in the log by the participant the day prior to a study visit, but may be recorded more frequently depending on site usual practice.",
      "display_markers": "T1:n9",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n9",
          "annotation_id": "annot-009"
        }
      ],
      "referenced_xacts": [
        "xact-025"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-010",
      "annotation_type": "footnote",
      "annotation_text": "The Participant Survey should be administered at early termination if it occurs before 26 weeks.",
      "display_markers": "T1:n10",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n10",
          "annotation_id": "annot-010"
        }
      ],
      "referenced_xacts": [
        "xact-031"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-031",
          "xcol_id": "xcol-019"
        }
      ],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-011",
      "annotation_type": "footnote",
      "annotation_text": "Collect serum estradiol, FSH, and LH in women whose menopausal status needs to be determined. For participants known to be either premenopausal or postmenopausal, these tests do not need to be collected.",
      "display_markers": "T1:n11",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n11",
          "annotation_id": "annot-011"
        }
      ],
      "referenced_xacts": [
        "xact-043",
        "xact-044",
        "xact-045"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-012",
      "annotation_type": "footnote",
      "annotation_text": "PK predose sample should be collected predose (~up to 1 hour predose).\nPK postdose sample time windows: 3-6 hours postdose (Week 4); 6-12 hours postdose (Week 8), 1-3 hours postdose (Week 16), 3-6 hours postdose (Week 26).\nParticipants may need to return to clinical site for additional PK-specific visits to provide postdose PK samples.",
      "display_markers": "T1:n12",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n12",
          "annotation_id": "annot-012"
        }
      ],
      "referenced_xacts": [
        "xact-062",
        "xact-063"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-013",
      "annotation_type": "footnote",
      "annotation_text": "One bottle of capsules is to be dispensed at Visit 3 and at Visit 4. Two bottles of capsules are to be dispensed at Visits 5-9 (during the rest of the dose escalation period). The site pharmacy should clearly label which bottle to take first. At Visits 10-17, 4 bottles of capsules should be dispensed.",
      "display_markers": "T1:n13",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "n13",
          "annotation_id": "annot-013"
        }
      ],
      "referenced_xacts": [
        "xact-069"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    }
  ],
  "review_items": [
    {
      "table_number": 1,
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 17,
        "row_positions": [
          67,
          68,
          69
        ]
      },
      "call_made": "The PK row is split into a mark-free parent 'Pharmacokinetic (PK) sample' with two child activities 'Predose' and 'Postdose', each carrying its own X marks. The words Predose/Postdose are printed in the Visit 1 (Screening) column position, but are treated as row sub-labels, so Visit 1 has no PK entry.",
      "alternative": "Treat 'Predose'/'Postdose' as the Visit 1 cell content (cell_value 'Predose'/'Postdose' at column 2), or emit two flat activities named 'Pharmacokinetic (PK) sample - Predose' / '- Postdose'.",
      "report_section": "4.2"
    },
    {
      "table_number": 1,
      "id": "D2",
      "severity": "high",
      "location": {
        "page": 16,
        "row_positions": [
          49,
          50,
          51
        ],
        "annotation_marker": "n11"
      },
      "call_made": "The note 'Collect serum estradiol, FSH, and LH in women whose menopausal status needs to be determined...' is printed under the FSH row only, but is bound to FSH (by position) and also to LH and Estradiol (by the tests it names).",
      "alternative": "Bind the note only to the FSH row it sits beside.",
      "report_section": "4.4"
    },
    {
      "table_number": 1,
      "id": "D3",
      "severity": "high",
      "location": {
        "page": 13,
        "row_position": 1,
        "annotation_marker": "n1"
      },
      "call_made": "The sentence inside the 'Study Period II Treatment Period' header cell ('For early terminations ... Shaded columns represent the dose escalation period Weeks 0-16.') is taken out of the header value and recorded as a note on each Treatment Period column (Visits 3-18).",
      "alternative": "Keep the sentence as part of the header cell text, or scope the note to the whole table (or only to the ET column / the shaded columns it mentions).",
      "report_section": "4.4"
    },
    {
      "table_number": 1,
      "id": "D4",
      "severity": "high",
      "location": {
        "page": 13,
        "row_position": 6
      },
      "call_made": "'Fasting Visit' is recorded as a header (schedule property) row describing which visits are fasting visits, not as an activity.",
      "alternative": "Record 'Fasting Visit' as an activity row with X marks (e.g. a fasting requirement performed at those visits).",
      "report_section": "4.1"
    },
    {
      "table_number": 1,
      "id": "D5",
      "severity": "high",
      "location": {
        "page": 15,
        "row_position": 37,
        "annotation_marker": "n10"
      },
      "call_made": "The Participant Survey note (administer at early termination if before 26 weeks) is bound to the Participant Survey activity as a whole.",
      "alternative": "Bind it only to the Participant Survey ET cell (column 20), since it governs the ET mark.",
      "report_section": "4.4"
    },
    {
      "table_number": 1,
      "id": "D6",
      "severity": "medium",
      "location": {
        "page": 13,
        "row_position": 2
      },
      "call_made": "The second header band ('Screening' over Visit 1, 'Lead-In' over Visit 2) is typed as 'period' (sub-phases of Study Period I) at level 2.",
      "alternative": "Type it as 'epoch' (Screening and Lead-In as epochs in their own right) or as visit names.",
      "report_section": "4.1"
    }
  ]
}