{ "schema_name": "soa-table-extraction", "schema_version": "1.0", "extraction_metadata": { "extracted_at": "2026-09-27T08:48:39Z", "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass", "prompt_version": "3.8.1", "source_document": { "filename": "NCT04677179_soa.pdf", "document_type": "protocol", "document_version": "J1P-MC-KFAH(b)" }, "extraction_status": "ready_for_resolution", "extraction_notes": "Single-pass extraction from NCT04677179_soa.pdf (Protocol J1P-MC-KFAH(b)). Marks read from pdftotext -bbox tokens binned to header column centres and checked visually against 110-dpi renders of every page. The abbreviation block below the table yields no annotations (no in-grid markers).", "model": "claude-opus-5-5" }, "table_metadata": { "table_number": 1, "table_type": "main_soa", "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_purpose": "Screening (V1) and induction treatment (V2-V9, Weeks 0-12) schedule for all participants", "page_start": 17, "page_end": 23, "notes": "Primary anchor schedule. Label column L=1 (activity name); data columns V1-V9 at positions 2-10; right-hand Comment column is a notes column (not a schedule column) whose cells are emitted as footnote annotations. Pages 18,21,22,23 (PDF 2,5,6,7) are full-page raster images with a glyph-spread text layer; pages 17,19,20 are vector text. Rows whose label is covered by a 'CCI' redaction box are transcribed with activity_name 'CCI'." }, "schedule_properties": [ { "table_number": 1, "row_position": 1, "property_name": "Visit number", "property_name_source": { "row_position": 1, "column_position": 1, "cell_value": "Visit number" }, "property_type": "visit", "property_comment": "Visit identifiers V1 (screening) and V2-V9 (induction); named visits, so property_type visit.", "hierarchical_level": 1, "annotation_markers": "t2,t3" }, { "table_number": 1, "row_position": 2, "property_name": "Weeks from randomization", "property_name_source": { "row_position": 2, "column_position": 1, "cell_value": "Weeks from randomization" }, "property_type": "week", "property_comment": "Week offset from randomization (-5 at screening, dash at V2/randomization, then 1-12); week numbers, so property_type week.", "hierarchical_level": 2 }, { "table_number": 1, "row_position": 3, "property_name": "Study day", "property_name_source": { "row_position": 3, "column_position": 1, "cell_value": "Study day" }, "property_type": "study_day", "property_comment": "Protocol study day (dash for screening, Day 1 at V2 through Day 85 at V9); property_type study_day.", "hierarchical_level": 3 }, { "table_number": 1, "row_position": 4, "property_name": "Visit interval tolerance (days)", "property_name_source": { "row_position": 4, "column_position": 1, "cell_value": "Visit interval tolerance (days)" }, "property_type": "window", "property_comment": "Allowed visit window in days (V1 up to 35 days before V2; ±3 days for V3-V9); property_type window.", "hierarchical_level": 4 }, { "table_number": 1, "row_position": 5, "property_name": "Fasting visit", "property_name_source": { "row_position": 5, "column_position": 1, "cell_value": "Fasting visit" }, "property_type": "other", "property_comment": "Shaded bold header-band row reprinted on every page marking the visits at which the participant attends fasting (X at V2 and V9). A visit attribute rather than a timing level; does not by itself distinguish columns, so hierarchical_level null and property_type other.", "hierarchical_level": null } ], "schedule_grid": [ { "table_number": 1, "row_position": 1, "column_position": 2, "cell_value": "V1", "annotation_markers": "t1" }, { "table_number": 1, "row_position": 1, "column_position": 3, "cell_value": "V2" }, { "table_number": 1, "row_position": 1, "column_position": 4, "cell_value": "V3" }, { "table_number": 1, "row_position": 1, "column_position": 5, "cell_value": "V4" }, { "table_number": 1, "row_position": 1, "column_position": 6, "cell_value": "V5" }, { "table_number": 1, "row_position": 1, "column_position": 7, "cell_value": "V6" }, { "table_number": 1, "row_position": 1, "column_position": 8, "cell_value": "V7" }, { "table_number": 1, "row_position": 1, "column_position": 9, "cell_value": "V8" }, { "table_number": 1, "row_position": 1, "column_position": 10, "cell_value": "V9", "annotation_markers": "t1" }, { "table_number": 1, "row_position": 2, "column_position": 2, "cell_value": "–5" }, { "table_number": 1, "row_position": 2, "column_position": 3, "cell_value": "—" }, { "table_number": 1, "row_position": 2, "column_position": 4, "cell_value": "1" }, { "table_number": 1, "row_position": 2, "column_position": 5, "cell_value": "2" }, { "table_number": 1, "row_position": 2, "column_position": 6, "cell_value": "4" }, { "table_number": 1, "row_position": 2, "column_position": 7, "cell_value": "6" }, { "table_number": 1, "row_position": 2, "column_position": 8, "cell_value": "8" }, { "table_number": 1, "row_position": 2, "column_position": 9, "cell_value": "10" }, { "table_number": 1, "row_position": 2, "column_position": 10, "cell_value": "12" }, { "table_number": 1, "row_position": 3, "column_position": 2, "cell_value": "—" }, { "table_number": 1, "row_position": 3, "column_position": 3, "cell_value": "1" }, { "table_number": 1, "row_position": 3, "column_position": 4, "cell_value": "8" }, { "table_number": 1, "row_position": 3, "column_position": 5, "cell_value": "15" }, { "table_number": 1, "row_position": 3, "column_position": 6, "cell_value": "29" }, { "table_number": 1, "row_position": 3, "column_position": 7, "cell_value": "43" }, { "table_number": 1, "row_position": 3, "column_position": 8, "cell_value": "57" }, { "table_number": 1, "row_position": 3, "column_position": 9, "cell_value": "71" }, { "table_number": 1, "row_position": 3, "column_position": 10, "cell_value": "85" }, { "table_number": 1, "row_position": 4, "column_position": 2, "cell_value": "≤35 before V2" }, { "table_number": 1, "row_position": 4, "column_position": 3, "cell_value": "—" }, { "table_number": 1, "row_position": 4, "column_position": 4, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 5, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 6, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 7, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 8, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 9, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 10, "cell_value": "±3" }, { "table_number": 1, "row_position": 5, "column_position": 2, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 5, "column_position": 4, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 5, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 6, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 7, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 8, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 9, "cell_value": "" }, { "table_number": 1, "row_position": 5, "column_position": 10, "cell_value": "X" } ], "activities": [ { "table_number": 1, "row_position": 6, "source_page": 17, "activity_name": "Informed consent", "activity_name_source": { "cell_text": "Informed consent", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 7, "source_page": 17, "activity_name": "Site staff explains, participant reports remission/normal stool frequency", "activity_name_source": { "cell_text": "Site staff explains, participant reports remission/normal stool frequency", "indentation_level": 0, "indentation_method": "visual_estimate" }, "annotation_markers": "c1" }, { "table_number": 1, "row_position": 8, "source_page": 17, "activity_name": "Inclusion and exclusion criteria, review and confirm", "activity_name_source": { "cell_text": "Inclusion and exclusion criteria, review and confirm", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 9, "source_page": 17, "activity_name": "Demographics", "activity_name_source": { "cell_text": "Demographics", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 10, "source_page": 17, "activity_name": "Preexisting conditions and medical history", "activity_name_source": { "cell_text": "Preexisting conditions and medical history", "indentation_level": 0, "indentation_method": "visual_estimate" }, "annotation_markers": "c2" }, { "table_number": 1, "row_position": 11, "source_page": 17, "activity_name": "Prespecified medical history", "activity_name_source": { "cell_text": "Prespecified medical history", "indentation_level": 0, "indentation_method": "visual_estimate" }, "annotation_markers": "c3" }, { "table_number": 1, "row_position": 12, "source_page": 17, "activity_name": "Prior treatments for indication", "activity_name_source": { "cell_text": "Prior treatments for indication", "indentation_level": 0, "indentation_method": "visual_estimate" }, "annotation_markers": "c4" }, { "table_number": 1, "row_position": 13, "source_page": 17, "activity_name": "Concomitant medications", "activity_name_source": { "cell_text": "Concomitant medications", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 14, "source_page": 17, "activity_name": "Adverse events", "activity_name_source": { "cell_text": "Adverse events", "indentation_level": 0, "indentation_method": "visual_estimate" }, "annotation_markers": "c5" }, { "table_number": 1, "row_position": 15, "source_page": 17, "activity_name": "Review modified Mayo score (MMS)", "activity_name_source": { "cell_text": "Review modified Mayo score (MMS)", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 16, "source_page": 17, "activity_name": "Tobacco use", "activity_name_source": { "cell_text": "Tobacco use", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 17, "source_page": 17, "activity_name": "Alcohol and caffeine use", "activity_name_source": { "cell_text": "Alcohol and caffeine use", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 18, "source_page": 18, "activity_name": "Physical Evaluation", "activity_name_source": { "cell_text": "Physical Evaluation", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ], "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 19, "source_page": 18, "activity_name": "Height", "activity_name_source": { "cell_text": "Height", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c6" }, { "table_number": 1, "row_position": 20, "source_page": 18, "activity_name": "Weight", "activity_name_source": { "cell_text": "Weight", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 21, "source_page": 18, "activity_name": "Vital signs", "activity_name_source": { "cell_text": "Vital signs", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c7" }, { "table_number": 1, "row_position": 22, "source_page": 18, "activity_name": "Physical examination", "activity_name_source": { "cell_text": "Physical examination", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c8" }, { "table_number": 1, "row_position": 23, "source_page": 18, "activity_name": "Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes", "activity_name_source": { "cell_text": "Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c9" }, { "table_number": 1, "row_position": 24, "source_page": 18, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 25, "source_page": 18, "activity_name": "12-lead electrocardiogram (ECG)", "activity_name_source": { "cell_text": "12-lead electrocardiogram (ECG)", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c10" }, { "table_number": 1, "row_position": 26, "source_page": 19, "activity_name": "Chest x-ray (posterior-anterior view)", "activity_name_source": { "cell_text": "Chest x-ray (posterior-anterior view)", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c11" }, { "table_number": 1, "row_position": 27, "source_page": 19, "activity_name": "Patient Diary (Electronic)", "activity_name_source": { "cell_text": "Patient Diary (Electronic)", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ] } }, { "table_number": 1, "row_position": 28, "source_page": 19, "activity_name": "Patient diary dispensed", "activity_name_source": { "cell_text": "Patient diary dispensed", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 29, "source_page": 19, "activity_name": "Diary compliance check", "activity_name_source": { "cell_text": "Diary compliance check", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c12" }, { "table_number": 1, "row_position": 30, "source_page": 19, "activity_name": "Patient-Reported Outcomes (Electronic)", "activity_name_source": { "cell_text": "Patient-Reported Outcomes (Electronic)", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ] } }, { "table_number": 1, "row_position": 31, "source_page": 19, "activity_name": "Inflammatory Bowel Disease Questionnaire (IBDQ)", "activity_name_source": { "cell_text": "Inflammatory Bowel Disease Questionnaire (IBDQ)", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 32, "source_page": 20, "activity_name": "Patient Global Impression of Change (PGI-C)", "activity_name_source": { "cell_text": "Patient Global Impression of Change (PGI-C)", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 33, "source_page": 20, "activity_name": "QIDS-SR16", "activity_name_source": { "cell_text": "QIDS-SR16", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 34, "source_page": 20, "activity_name": "Clinician-Administered Questionnaires (Paper)", "activity_name_source": { "cell_text": "Clinician-Administered Questionnaires (Paper)", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ] } }, { "table_number": 1, "row_position": 35, "source_page": 20, "activity_name": "Physician’s Global Assessment (PGA)", "activity_name_source": { "cell_text": "Physician’s Global Assessment (PGA)", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 36, "source_page": 20, "activity_name": "C-SSRS Screening/Baseline", "activity_name_source": { "cell_text": "C-SSRS Screening/Baseline", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c13" }, { "table_number": 1, "row_position": 37, "source_page": 20, "activity_name": "Self-Harm Supplement Form", "activity_name_source": { "cell_text": "Self-Harm Supplement Form", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 38, "source_page": 20, "activity_name": "Self-Harm Follow-Up Form", "activity_name_source": { "cell_text": "Self-Harm Follow-Up Form", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c14" }, { "table_number": 1, "row_position": 39, "source_page": 20, "activity_name": "Laboratory Tests and Sample Collections", "activity_name_source": { "cell_text": "Laboratory Tests and Sample Collections", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ] } }, { "table_number": 1, "row_position": 40, "source_page": 20, "activity_name": "Hematology", "activity_name_source": { "cell_text": "Hematology", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 41, "source_page": 20, "activity_name": "Clinical chemistry", "activity_name_source": { "cell_text": "Clinical chemistry", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 42, "source_page": 20, "activity_name": "Lipid panel", "activity_name_source": { "cell_text": "Lipid panel", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c15" }, { "table_number": 1, "row_position": 43, "source_page": 20, "activity_name": "Urinalysis", "activity_name_source": { "cell_text": "Urinalysis", "indentation_level": 1, "indentation_method": "font_signal" } }, { "table_number": 1, "row_position": 44, "source_page": 20, "activity_name": "Serum pregnancy", "activity_name_source": { "cell_text": "Serum pregnancy", "indentation_level": 1, "indentation_method": "font_signal" }, "annotation_markers": "c16" }, { "table_number": 1, "row_position": 45, "source_page": 21, "activity_name": "Urine pregnancy (local)", "activity_name_source": { "cell_text": "Urine pregnancy (local)", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c17" }, { "table_number": 1, "row_position": 46, "source_page": 21, "activity_name": "Follicle-stimulating hormone (FSH)", "activity_name_source": { "cell_text": "Follicle-stimulating hormone (FSH)", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c18" }, { "table_number": 1, "row_position": 47, "source_page": 21, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 48, "source_page": 21, "activity_name": "Tuberculosis (TB) test", "activity_name_source": { "cell_text": "Tuberculosis (TB) test", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c19" }, { "table_number": 1, "row_position": 49, "source_page": 21, "activity_name": "Human immunodeficiency virus (HIV) screening tests", "activity_name_source": { "cell_text": "Human immunodeficiency virus (HIV) screening tests", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 50, "source_page": 21, "activity_name": "Hepatitis C virus (HCV) screening tests", "activity_name_source": { "cell_text": "Hepatitis C virus (HCV) screening tests", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c20" }, { "table_number": 1, "row_position": 51, "source_page": 21, "activity_name": "Hepatitis B virus (HBV) screening tests", "activity_name_source": { "cell_text": "Hepatitis B virus (HBV) screening tests", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c21" }, { "table_number": 1, "row_position": 52, "source_page": 22, "activity_name": "HBV DNA", "activity_name_source": { "cell_text": "HBV DNA", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c22" }, { "table_number": 1, "row_position": 53, "source_page": 22, "activity_name": "Pharmacokinetic (PK) samples", "activity_name_source": { "cell_text": "Pharmacokinetic (PK) samples", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c23" }, { "table_number": 1, "row_position": 54, "source_page": 22, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c23" }, { "table_number": 1, "row_position": 55, "source_page": 22, "activity_name": "Flow cytometry panel", "activity_name_source": { "cell_text": "Flow cytometry panel", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 56, "source_page": 22, "activity_name": "Genetics sample", "activity_name_source": { "cell_text": "Genetics sample", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c24" }, { "table_number": 1, "row_position": 57, "source_page": 22, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 58, "source_page": 22, "activity_name": "Endoscopic Procedure", "activity_name_source": { "cell_text": "Endoscopic Procedure", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ], "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 59, "source_page": 22, "activity_name": "Endoscopy", "activity_name_source": { "cell_text": "Endoscopy", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c25" }, { "table_number": 1, "row_position": 60, "source_page": 22, "activity_name": "Colon biopsy sample collection", "activity_name_source": { "cell_text": "Colon biopsy sample collection", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c26" }, { "table_number": 1, "row_position": 61, "source_page": 23, "activity_name": "Stool Samples", "activity_name_source": { "cell_text": "Stool Samples", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ], "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 62, "source_page": 23, "activity_name": "Stool culture", "activity_name_source": { "cell_text": "Stool culture", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c27" }, { "table_number": 1, "row_position": 63, "source_page": 23, "activity_name": "C. difficile testing", "activity_name_source": { "cell_text": "C. difficile testing", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c28" }, { "table_number": 1, "row_position": 64, "source_page": 23, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 65, "source_page": 23, "activity_name": "CCI", "activity_name_source": { "cell_text": "CCI", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 66, "source_page": 23, "activity_name": "Randomization and Dosing", "activity_name_source": { "cell_text": "Randomization and Dosing", "indentation_level": 0, "indentation_method": "font_signal", "text_formatting": [ "bold" ], "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 67, "source_page": 23, "activity_name": "Randomization", "activity_name_source": { "cell_text": "Randomization", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" } }, { "table_number": 1, "row_position": 68, "source_page": 23, "activity_name": "Dosing", "activity_name_source": { "cell_text": "Dosing", "indentation_level": 1, "indentation_method": "font_signal", "method": "glyph_reconstruction" }, "annotation_markers": "c29" } ], "activity_schedule": [ { "table_number": 1, "row_position": 6, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 7, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 8, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 8, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 9, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 10, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 11, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 12, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 15, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 15, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 16, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 16, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 17, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 19, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 22, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 23, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 23, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 25, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 25, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 26, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 32, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 33, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 33, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 37, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 42, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 42, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 43, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 43, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 43, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 43, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 44, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 46, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 49, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 50, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 51, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 53, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 55, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 55, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 55, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 59, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 59, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 64, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 64, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 64, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 64, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 10, "cell_value": "X" } ], "annotations": [ { "annotation_marker": "t1", "annotation_type": "footnote", "annotation_text": "V1 and V9 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.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 2, "method": "text_match" }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 10, "method": "text_match" } ] }, { "annotation_marker": "t2", "annotation_type": "source_note", "annotation_text": "For procedures at an ETV, see ETV in Table 4.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_property", "row_position": 1, "method": "synthesized" } ] }, { "annotation_marker": "t3", "annotation_type": "source_note", "annotation_text": "For procedures at an unscheduled visit, see V997 in Table 4.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_property", "row_position": 1, "method": "synthesized" } ] }, { "annotation_marker": "c1", "annotation_type": "footnote", "annotation_text": "The purpose of UC remission question should be explained before the participant answers the question. Errors in the response cannot be corrected after the participant saves and confirms the response.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 7, "method": "synthesized" } ] }, { "annotation_marker": "c2", "annotation_type": "footnote", "annotation_text": "Includes relevant surgical history.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 10, "method": "synthesized" } ] }, { "annotation_marker": "c3", "annotation_type": "footnote", "annotation_text": "Indication and history of interest.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 11, "method": "synthesized" } ] }, { "annotation_marker": "c4", "annotation_type": "footnote", "annotation_text": "Includes all UC-specific therapies since date of diagnosis.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 12, "method": "synthesized" } ] }, { "annotation_marker": "c5", "annotation_type": "footnote", "annotation_text": "For AESIs, additional data are collected (Section 8.3.6).", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 14, "method": "synthesized" } ] }, { "annotation_marker": "c6", "annotation_type": "footnote", "annotation_text": "Participant should remove shoes.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 19, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c7", "annotation_type": "footnote", "annotation_text": "Blood pressure, body temperature, and pulse rate. Vital signs should be measured after participant has been sitting at least 5 minutes.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 21, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c8", "annotation_type": "footnote", "annotation_text": "The complete physical exam excludes pelvic, rectal, and breast exams, unless clinically indicated, and includes assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes. See Section 8.2.2.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 22, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c9", "annotation_type": "source_note", "annotation_text": "See Section 8.2.2.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 23, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c10", "annotation_type": "footnote", "annotation_text": "Locally performed.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 25, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c11", "annotation_type": "footnote", "annotation_text": "Interpreted and reported by radiologist or pulmonologist. Not done at screening if done within 3 months before screening and if qualifying radiographs or equivalent imaging study and/or formal report are available for investigator’s review. Lateral view may also be taken. Locally performed.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 26, "method": "synthesized" } ] }, { "annotation_marker": "c12", "annotation_type": "footnote", "annotation_text": "Check compliance for\nStool Frequency\nRectal Bleeding\nNocturnal Stools\nBristol Stool Scale\nUrgency NRS\nAbdominal Pain NRS\nFatigue NRS, and\nPatient Global Rating of Severity (PGR-S).", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 29, "method": "synthesized" } ] }, { "annotation_marker": "c13", "annotation_type": "footnote", "annotation_text": "Adapted for the assessment of ideation and behavior categories only.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 36, "method": "synthesized" } ] }, { "annotation_marker": "c14", "annotation_type": "footnote", "annotation_text": "Required if triggered by the Self-Harm Supplement Form per instructions.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 38, "method": "synthesized" } ] }, { "annotation_marker": "c15", "annotation_type": "footnote", "annotation_text": "Fasting samples are preferred, but if participant is non fasting at time of collection, this is not a protocol deviation.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 42, "method": "synthesized" } ] }, { "annotation_marker": "c16", "annotation_type": "footnote", "annotation_text": "Perform only for women of childbearing potential and women with a history of tubal ligation.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 44, "method": "synthesized" } ] }, { "annotation_marker": "c17", "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.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 45, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c18", "annotation_type": "footnote", "annotation_text": "Optional, perform only for women not of childbearing potential to confirm postmenopausal status.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 46, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c19", "annotation_type": "footnote", "annotation_text": "Patients who had a tuberculin skin test (TST) will return from 48 to 72 hours after placement to have the test result read. Samples may be sent to central or local laboratory based on the type of test. A local laboratory must be qualified by local regulations.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 48, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c20", "annotation_type": "footnote", "annotation_text": "HCV RNA will be measured to confirm positive hepatitis C virus antibody.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 50, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c21", "annotation_type": "footnote", "annotation_text": "Includes testing for HBsAg and anti-HBc.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 51, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c22", "annotation_type": "footnote", "annotation_text": "Only for participants who are positive for anti-HBc at screening.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 52, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c23", "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.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 53, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 54, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c24", "annotation_type": "footnote", "annotation_text": "Blood sample for DNA pharmacogenetics can be obtained any time at or after V2.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 56, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c25", "annotation_type": "footnote", "annotation_text": "Screening endoscopy must occur ≤14 days prior to randomization. At screening, perform only for participants who are eligible for the study by all other study entry criteria.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 59, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c26", "annotation_type": "footnote", "annotation_text": "Performed at time of endoscopy. Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 60, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c27", "annotation_type": "footnote", "annotation_text": "Additional local stool testing (for example, for ova and parasites) is allowed at the investigator’s discretion.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 62, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c28", "annotation_type": "footnote", "annotation_text": "Additional C. difficile testing is allowed throughout the study at the investigator’s discretion.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 63, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } }, { "annotation_marker": "c29", "annotation_type": "footnote", "annotation_text": "No dosing at V3.", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 68, "method": "synthesized" } ], "annotation_text_source": { "method": "deglyph_reconstruction", "note": "Text rebuilt from glyph-spread text layer over a full-page raster; cell bounds confirmed against the rendered page grid." } } ], "review_items": [ { "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" }, { "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" }, { "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" } ] }