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    "notes": "Independent schedule with its own visit columns (ETV, V997, V801, V802) referenced by Tables 1-3 for early termination and unscheduled visits; typed main_soa (alternative: track for the follow-up phase, see review item D11). L=1; data columns positions 2-5. Page 46 contributes only the Randomization and Dosing header and a mark-free Dosing row whose comment states no dosing in this period."
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      "annotation_marker": "t1",
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      "annotation_marker": "c3",
      "annotation_type": "footnote",
      "annotation_text": "For AESIs, additional data are collected (Section 8.3.6).",
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      "annotation_text": "See Section 8.2.2.",
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      "annotation_type": "footnote",
      "annotation_text": "Perform only for women of childbearing potential and women with a history of tubal ligation. At dosing visits which have pregnancy testing, the pregnancy test result must be confirmed to be negative prior to dosing. Pregnancy testing may be performed more frequently than designated on the SoA if local laws or regulations require more frequent testing.",
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    },
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      "annotation_marker": "c10",
      "annotation_type": "footnote",
      "annotation_text": "Collect samples before dosing, if dosing is scheduled. Collect additional samples at specified times relative to onset of hypersensitivity events.",
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      "annotation_text": "Blood sample for DNA pharmacogenetics can be obtained any time at or after V2.",
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      "annotation_marker": "c12",
      "annotation_type": "footnote",
      "annotation_text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor. If not performed at ETV, this will not be considered a protocol deviation.",
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      "annotation_text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor. Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed. If not performed at ETV, this will not be considered a protocol deviation.",
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      "id": "D11",
      "severity": "medium",
      "location": {
        "page": 43
      },
      "call_made": "Table 4 (ETV, unscheduled visit V997 and post-treatment follow-up V801/V802) is typed 'main_soa' as an independent schedule with its own visit columns that applies to all participants.",
      "alternative": "Type it 'track' (track_label e.g. 'Follow-Up') as a separate study phase timeline.",
      "report_section": "T4.1"
    },
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      "severity": "medium",
      "location": {
        "page": 43,
        "row_position": 1,
        "annotation_marker": "t1"
      },
      "call_made": "The title-cell note 'V802 is only for randomized participants who were positive for anti-HBc…' is bound to the V802 cell and 'V997: Additional study procedures…' to the V997 cell of the Visit number row.",
      "alternative": "Bind both as table-wide notes to the Visit number property row.",
      "report_section": "T4.5"
    },
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      "id": "D13",
      "severity": "medium",
      "location": {
        "page": 43,
        "annotation_marker": "c4"
      },
      "call_made": "The Vital signs comment, which ends with 'V997: Vital signs collection is optional.', is kept as one footnote on the Vital signs row (one rule-bounded cell).",
      "alternative": "Split the V997 sentence into its own note bound to the Vital signs × V997 cell.",
      "report_section": "T4.5"
    }
  ]
}