{
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  "schema_version": "1.5",
  "protocol_id": "NCT04573309",
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    "consolidated_at": "2026-10-03T15:51:01.571629+00:00",
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        "column_count": 24,
        "annotation_count": 25,
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      "location": {
        "page": 14,
        "row_positions": [
          1,
          2
        ]
      },
      "call_made": "The top header band (Screening / C-I / UNS / EOS or ET) is typed as the study phase (epoch, level 1) and the second band (Inpatient Period 1 / OP / Inpatient Period 2) as sub-periods (period, level 2); both names are synthesised because the label cell only reads 'Study Procedures'.",
      "alternative": "Type the top band as visit categories (visit) — Screening, Check-in, Unscheduled and EOS/ET read as visit names — and keep the second band as epoch.",
      "report_section": "2.2"
    },
    {
      "table_number": 1,
      "id": "D2",
      "severity": "high",
      "location": {
        "page": 14,
        "row_positions": [
          23,
          24
        ]
      },
      "call_made": "The arrows after the X in 'Discontinue chelation therapy' (X at Day -4 through -1) and 'Discontinue zinc therapy' (X at Day -21) are distributed as '→' over every following column through the EOS column (8:25 and 4:25), including the UNS column, because the drawn arrowhead ends inside the EOS column.",
      "alternative": "Stop the arrow span at Day 40 (column 23), treating the arrowhead overshoot into UNS/EOS as drawing slack, or keep only the X and treat the arrow as 'discontinued for the rest of the study' without per-column entries.",
      "report_section": "2.3"
    },
    {
      "table_number": 1,
      "id": "D3",
      "severity": "high",
      "location": {
        "page": 15,
        "row_position": 31
      },
      "call_made": "'PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu' (first row on page 15) is transcribed with no marks, exactly as printed.",
      "alternative": "Treat it as the second half of the PK blood-sampling row split by the page break (Table 2 prints PK and PD in one cell sharing marks) and copy the PK row's marks (Days 1, 4-7, 25, 26-28, 29, 30-35, 36, 37-38, 39, 40, with footnote p at Days 1, 25, 29, 39) onto the PD row.",
      "report_section": "2.4"
    },
    {
      "table_number": 2,
      "id": "D4",
      "severity": "medium",
      "location": {
        "page": 17,
        "row_positions": [
          2,
          3
        ]
      },
      "call_made": "The single body cell of Table 2, which lists 'Blood sampling for PK: Plasma total Mo and PUF-Mo' and 'PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu' on separate lines with one set of marks, is split into two activities (matching the two Table 1 rows) and every mark is emitted on both.",
      "alternative": "Keep it as one combined activity 'Blood sampling for PK ... / PD ...' carrying the marks once.",
      "report_section": "3.2"
    }
  ]
}