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        "xact-033"
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      "occurrence_count": 1
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      "cell_references": [],
      "occurrence_count": 1
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        "xact-039"
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      "cell_references": [],
      "occurrence_count": 1
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          "marker": "c17",
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          "marker": "c17",
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        "xact-040"
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      "referenced_xcols": [],
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      "cell_references": [],
      "occurrence_count": 2
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      "xannot_id": "xannot-021",
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          "marker": "c18",
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      "referenced_xacts": [
        "xact-041"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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          "table_num": 1,
          "marker": "c19",
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      "referenced_xacts": [
        "xact-043"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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      "xannot_id": "xannot-023",
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          "table_num": 1,
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      "referenced_xacts": [
        "xact-045"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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      "xannot_id": "xannot-024",
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        {
          "table_num": 1,
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      "referenced_xacts": [
        "xact-046"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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      "xannot_id": "xannot-025",
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        {
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          "marker": "c22",
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        {
          "table_num": 2,
          "marker": "c22",
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        {
          "table_num": 3,
          "marker": "c22",
          "annotation_id": "annot-014"
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          "table_num": 4,
          "marker": "c9",
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      "referenced_xacts": [
        "xact-047"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 4
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      "xannot_id": "xannot-026",
      "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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        {
          "table_num": 1,
          "marker": "c23",
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        {
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          "marker": "c23",
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        {
          "table_num": 3,
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          "table_num": 4,
          "marker": "c10",
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        "xact-048",
        "xact-049",
        "xact-042"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 4
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      "xannot_id": "xannot-027",
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      "annotation_text": "Blood sample for DNA pharmacogenetics can be obtained any time at or after V2.",
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        {
          "table_num": 1,
          "marker": "c24",
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          "marker": "c24",
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        {
          "table_num": 3,
          "marker": "c24",
          "annotation_id": "annot-016"
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          "table_num": 4,
          "marker": "c11",
          "annotation_id": "annot-013"
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      ],
      "referenced_xacts": [
        "xact-051"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 4
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        {
          "table_num": 1,
          "marker": "c25",
          "annotation_id": "annot-028"
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      "referenced_xacts": [
        "xact-054"
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      "referenced_xcols": [],
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      "cell_references": [],
      "occurrence_count": 1
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        {
          "table_num": 1,
          "marker": "c26",
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        {
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          "marker": "c26",
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          "table_num": 3,
          "marker": "c26",
          "annotation_id": "annot-017"
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      "referenced_xacts": [
        "xact-055"
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      "referenced_xcols": [],
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      "cell_references": [],
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      "referenced_xacts": [
        "xact-057"
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      "referenced_xcols": [],
      "referenced_props": [],
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      "occurrence_count": 1
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          "marker": "c28",
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      "referenced_xacts": [
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        "xact-063"
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      "occurrence_count": 1
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        {
          "table_num": 2,
          "marker": "t1",
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      "referenced_xacts": [],
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      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
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          "marker": "t3",
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      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
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      "annotation_text": "Visits 10 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof), if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring.",
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      "source_occurrences": [
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          "marker": "t5",
          "annotation_id": "annot-005"
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        "xcol-010",
        "xcol-011",
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        "xcol-014",
        "xcol-015",
        "xcol-016",
        "xcol-017",
        "xcol-018",
        "xcol-019"
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      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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      "annotation_text": "Visits 10 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof) if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring.",
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      "source_occurrences": [
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          "table_num": 2,
          "marker": "t6",
          "annotation_id": "annot-006"
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      "referenced_xcols": [
        "xcol-020",
        "xcol-021",
        "xcol-022",
        "xcol-023",
        "xcol-024",
        "xcol-025",
        "xcol-026",
        "xcol-027",
        "xcol-028"
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      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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      "xannot_id": "xannot-037",
      "annotation_type": "footnote",
      "annotation_text": "Blood pressure, body temperature, and pulse rate. Vital signs should be measured after participant has been sitting for at least 5 minutes.",
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        {
          "table_num": 2,
          "marker": "c7",
          "annotation_id": "annot-008"
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        {
          "table_num": 3,
          "marker": "c7",
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        {
          "table_num": 4,
          "marker": "c4",
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      "cell_references": [],
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      "xannot_id": "xannot-038",
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      "annotation_text": "Fasting samples are preferred, but if participant is nonfasting at time of collection, this is not a protocol deviation.",
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        {
          "table_num": 2,
          "marker": "c15",
          "annotation_id": "annot-012"
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        {
          "table_num": 3,
          "marker": "c15",
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      "referenced_xacts": [
        "xact-037"
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      "cell_references": [],
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    {
      "xannot_id": "xannot-039",
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      "annotation_text": "No dosing at V29.",
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        {
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          "marker": "c29",
          "annotation_id": "annot-018"
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          "table_num": 3,
          "marker": "c29",
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        "xact-063"
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      "occurrence_count": 2
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      "xannot_id": "xannot-040",
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      "annotation_text": "Not applicable for responders during the time period of V10 through V19",
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          "marker": "c30",
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      "referenced_xacts": [
        "xact-053"
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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    {
      "xannot_id": "xannot-041",
      "annotation_type": "footnote",
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          "marker": "t1",
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          "marker": "t5",
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        "xcol-038",
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      "occurrence_count": 1
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          "table_num": 3,
          "marker": "t6",
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      "referenced_xacts": [],
      "referenced_xcols": [
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        "xcol-041",
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        "xcol-043",
        "xcol-044",
        "xcol-045",
        "xcol-046",
        "xcol-047",
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      "cell_references": [],
      "occurrence_count": 1
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      "xannot_id": "xannot-044",
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      "annotation_text": "V16 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance and all scheduled activities are completed prior to dosing",
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          "marker": "t7",
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      "referenced_xacts": [],
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      "xannot_id": "xannot-045",
      "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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          "table_num": 3,
          "marker": "c17",
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        {
          "table_num": 4,
          "marker": "c8",
          "annotation_id": "annot-010"
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      "cell_references": [],
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      "xannot_id": "xannot-046",
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      "annotation_text": "V802 is only for randomized participants who were positive for anti-HBc at screening. All other participants will have their final visit at V801 or ETV.",
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          "marker": "t1",
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      "xannot_id": "xannot-047",
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      "annotation_text": "V997: Additional study procedures can be performed at the discretion of the investigator.",
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        {
          "table_num": 4,
          "marker": "t2",
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      "referenced_xacts": [],
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      "cell_references": [],
      "occurrence_count": 1
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    {
      "xannot_id": "xannot-048",
      "annotation_type": "footnote",
      "annotation_text": "The intervals between ETV and the post-treatment follow-up visit(s) should be adequate to ensure that V801 occurs at least 8 weeks since last dose and V802 (if applicable) occurs at least 16 weeks since last dose.",
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      "source_occurrences": [
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          "table_num": 4,
          "marker": "c1",
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      "referenced_xacts": [],
      "referenced_xcols": [
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        "xcol-053"
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      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-049",
      "annotation_type": "footnote",
      "annotation_text": "No fasting in this period",
      "display_markers": "T4:c2",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c2",
          "annotation_id": "annot-004"
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      ],
      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [
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      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-050",
      "annotation_type": "footnote",
      "annotation_text": "Fasting is not required for the lipid panel at ETV.",
      "display_markers": "T4:c7",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c7",
          "annotation_id": "annot-009"
        }
      ],
      "referenced_xacts": [
        "xact-037"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-037",
          "xcol_id": "xcol-050"
        }
      ],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-051",
      "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.",
      "display_markers": "T4:c12",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c12",
          "annotation_id": "annot-014"
        }
      ],
      "referenced_xacts": [
        "xact-054"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-054",
          "xcol_id": "xcol-050"
        }
      ],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-052",
      "annotation_type": "footnote",
      "annotation_text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor.",
      "display_markers": "T4:c13",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c13",
          "annotation_id": "annot-015"
        }
      ],
      "referenced_xacts": [
        "xact-055"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-055",
          "xcol_id": "xcol-050"
        }
      ],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-053",
      "annotation_type": "footnote",
      "annotation_text": "No dosing at ETV, V997, or post-treatment follow-up visits.",
      "display_markers": "T4:c14",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c14",
          "annotation_id": "annot-016"
        }
      ],
      "referenced_xacts": [
        "xact-063"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-054",
      "annotation_type": "footnote",
      "annotation_text": "V997: Vital signs collection is optional.",
      "display_markers": "T4:c15",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c15",
          "annotation_id": "annot-017"
        }
      ],
      "referenced_xacts": [
        "xact-016"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-016",
          "xcol_id": "xcol-051"
        }
      ],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-055",
      "annotation_type": "footnote",
      "annotation_text": "Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.",
      "display_markers": "T4:c16",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c16",
          "annotation_id": "annot-018"
        }
      ],
      "referenced_xacts": [
        "xact-055"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-056",
      "annotation_type": "footnote",
      "annotation_text": "If not performed at ETV, this will not be considered a protocol deviation.",
      "display_markers": "T4:c17",
      "source_occurrences": [
        {
          "table_num": 4,
          "marker": "c17",
          "annotation_id": "annot-019"
        }
      ],
      "referenced_xacts": [
        "xact-055"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [
        {
          "xact_id": "xact-055",
          "xcol_id": "xcol-050"
        }
      ],
      "occurrence_count": 1
    }
  ],
  "review_items": [
    {
      "table_number": 1,
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 17,
        "row_position": 5
      },
      "call_made": "The shaded 'Fasting visit' band (X at V2 and V9, reprinted on every page) is recorded as a header schedule_property, not as an activity row; the same treatment is applied in Tables 2-4.",
      "alternative": "Record 'Fasting visit' as a level-0 activity row carrying X marks at the fasting visits.",
      "report_section": "T1.3"
    },
    {
      "table_number": 1,
      "id": "D2",
      "severity": "high",
      "location": {
        "page": 17,
        "row_position": 1,
        "annotation_marker": "t1"
      },
      "call_made": "The title-cell instruction 'V1 and V9 procedures may be conducted over more than 1 day…' is bound to the V1 and V9 cells of the Visit number row (by the visits it names).",
      "alternative": "Treat it as a table-wide note bound to the Visit number property row as a whole.",
      "report_section": "T1.5"
    },
    {
      "table_number": 1,
      "id": "D3",
      "severity": "low",
      "location": {
        "page": 17,
        "row_positions": [
          6,
          7,
          8,
          9,
          10,
          11,
          12,
          13,
          14,
          15,
          16,
          17
        ]
      },
      "call_made": "Rows printed above the first section header (Informed consent … Alcohol and caffeine use) are recorded at indentation level 0 as stand-alone activities with marks; the same convention is used for the ungrouped top rows of Tables 2-4.",
      "alternative": "Record them at level 1 as children of an implicit, unnamed general group.",
      "report_section": "T1.4"
    },
    {
      "table_number": 2,
      "id": "D4",
      "severity": "medium",
      "location": {
        "page": 24
      },
      "call_made": "Table 2 is typed 'track' (track_label 'Responders') because its population statement restricts it to participants who are responders at Week 12, mutually exclusive with Table 3 (nonresponders).",
      "alternative": "Type it 'main_soa' as an independent maintenance-period schedule.",
      "report_section": "T2.1"
    },
    {
      "table_number": 2,
      "id": "D5",
      "severity": "high",
      "location": {
        "page": 28
      },
      "call_made": "'Table 2 (continued)' (pages 28-32, V20-V29) is treated as the second column tile of one horizontally tiled Table 2: rows are unioned by name and marks of both tiles merged into one 20-column table. Redacted 'CCI' rows are matched across tiles by their position between the same named neighbour rows.",
      "alternative": "Extract 'Table 2 (continued)' as a separate continuation table, or match the redacted rows differently (their identity cannot be confirmed from the text).",
      "report_section": "T2.2"
    },
    {
      "table_number": 2,
      "id": "D6",
      "severity": "medium",
      "location": {
        "page": 24,
        "row_position": 1,
        "annotation_marker": "t5"
      },
      "call_made": "The title-cell remote-visit note is bound to the Visit number cells it names (tile 1: V10-V19 as t5; tile 2: V20-V28 as t6, V29 excluded because 'Visits 10 through 28'). The tile-2 wording differs only by a missing comma, and the ETV cross-reference is worded differently in tile 2, so the variants are kept as separate annotations.",
      "alternative": "Merge each pair of near-identical tile variants into one annotation and/or bind the remote-visit note to the whole Visit number row.",
      "report_section": "T2.5"
    },
    {
      "table_number": 2,
      "id": "D7",
      "severity": "high",
      "location": {
        "page": 27,
        "annotation_marker": "c30"
      },
      "call_made": "The comment 'Not applicable for responders during the time period of V10 through V19' printed on the 'Endoscopic Procedure' section-header row is bound to that header row (activity_name), so it governs the group; its child rows (Endoscopy, Colon biopsy) print only in the V20-V29 tile.",
      "alternative": "Bind the note to the Endoscopy and Colon biopsy sample collection rows, or to the V10-V19 columns.",
      "report_section": "T2.5"
    },
    {
      "table_number": 3,
      "id": "D8",
      "severity": "medium",
      "location": {
        "page": 33
      },
      "call_made": "Table 3 is typed 'track' (track_label 'Nonresponders'): it applies only to participants who are nonresponders at Week 12, mutually exclusive with Table 2, although both number their visits V10-V29.",
      "alternative": "Type it 'domain' of Table 2 (same visit columns) or 'main_soa'.",
      "report_section": "T3.1"
    },
    {
      "table_number": 3,
      "id": "D9",
      "severity": "high",
      "location": {
        "page": 38
      },
      "call_made": "'Table 3 (continued)' (pages 38-42, V20-V29) is treated as the second column tile of one tiled Table 3; rows unioned by name, redacted 'CCI' rows matched across tiles by position.",
      "alternative": "Extract 'Table 3 (continued)' as a separate continuation table, or match redacted rows differently.",
      "report_section": "T3.2"
    },
    {
      "table_number": 3,
      "id": "D10",
      "severity": "medium",
      "location": {
        "page": 33,
        "row_position": 1,
        "annotation_marker": "t5"
      },
      "call_made": "The remote-visit note 'Visits 17 through 28…' is bound to the V17-V19 cells (tile 1, t5) and V20-V28 cells (tile 2, t6; tile-2 text lacks the final period); the V16 multi-day note (t7) is bound to the V16 cell.",
      "alternative": "Bind both notes to the Visit number row as table-wide notes, or merge the two remote-visit variants.",
      "report_section": "T3.5"
    },
    {
      "table_number": 4,
      "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"
    },
    {
      "table_number": 4,
      "id": "D12",
      "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"
    },
    {
      "table_number": 4,
      "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"
    }
  ]
}