{ "schema_name": "soa-table-extraction", "schema_version": "1.0", "extraction_metadata": { "extracted_at": "2026-09-27T12:40:41Z", "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass", "prompt_version": "3.8.1", "source_document": { "filename": "NCT03548987_soa.pdf", "document_type": "protocol", "document_version": "2.0", "document_date": "21 December 2017" }, "extraction_status": "ready_for_resolution", "extraction_notes": "Trial ID NN9536-4376. Single flowchart printed on document pages 8-11 (rotated landscape) with the 4 header rows reprinted on every page; header rows de-duplicated. Text layer present; marks verified by pdftotext -bbox binning into cell rectangles recovered from raster rule lines (200 dpi); matrix matched visual read on all 4 pages. No merged body cells. Inline section/appendix references stripped from activity names into source_note annotations pr1-pr29.", "model": "claude-opus-5-5" }, "table_metadata": { "table_number": 1, "table_type": "main_soa", "table_title": "Flowchart", "table_purpose": "Main schedule of activities across screening, run-in, randomisation, maintenance, end of treatment and end of trial", "page_start": 8, "page_end": 11, "notes": "One label column (L=1); data columns 2-26 (V1..V25). Header rows reprint on each page and are recorded once; body rows continue across pages, so this is one table rather than a continuation." }, "schedule_properties": [ { "table_number": 1, "row_position": 1, "property_name": "Period", "property_name_source": { "row_position": 1, "column_position": 1, "cell_value": "", "synthesized": true }, "property_type": "epoch", "hierarchical_level": 1, "property_comment": "Unlabelled top header band of merged cells naming study periods (Screening, Run-in, Randomisation, Maintenance period, End of treatment, End of trial); major study phases, hence epoch. Name synthesised because the label cell is empty." }, { "table_number": 1, "row_position": 2, "property_name": "Visit(V), Phone (P)", "property_name_source": { "row_position": 2, "column_position": 1, "cell_value": "Visit(V), Phone (P)" }, "property_type": "visit", "hierarchical_level": 2, "property_comment": "Visit identifiers V1-V25; prefix V = site visit, P = phone contact (per the row label). Named visits, hence visit; the V/P prefix also encodes contact modality." }, { "table_number": 1, "row_position": 3, "property_name": "Timing of Visit (Weeks)", "property_name_source": { "row_position": 3, "column_position": 1, "cell_value": "Timing of Visit (Weeks)" }, "property_type": "week", "hierarchical_level": 3, "property_comment": "Nominal timing of each visit in weeks (-1 to 75), hence week." }, { "table_number": 1, "row_position": 4, "property_name": "Visit Window (Days)", "property_name_source": { "row_position": 4, "column_position": 1, "cell_value": "Visit Window (Days)" }, "property_type": "window", "hierarchical_level": 4, "property_comment": "Allowed visit window in days per visit (-7 to 0, 0, ±3, 0 to +5), hence window." } ], "schedule_grid": [ { "table_number": 1, "row_position": 1, "column_position": 2, "cell_value": "Screening" }, { "table_number": 1, "row_position": 1, "column_position": 3, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 4, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 5, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 6, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 7, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 8, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 9, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 10, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 11, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 12, "cell_value": "Run-in", "is_merged_cell": true, "merged_cell_range": "3:12" }, { "table_number": 1, "row_position": 1, "column_position": 13, "cell_value": "Randomisation" }, { "table_number": 1, "row_position": 1, "column_position": 14, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 15, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 16, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 17, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 18, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 19, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 20, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 21, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 22, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 23, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 24, "cell_value": "Maintenance period", "is_merged_cell": true, "merged_cell_range": "14:24" }, { "table_number": 1, "row_position": 1, "column_position": 25, "cell_value": "End of treatment" }, { "table_number": 1, "row_position": 1, "column_position": 26, "cell_value": "End of trial" }, { "table_number": 1, "row_position": 2, "column_position": 2, "cell_value": "V1" }, { "table_number": 1, "row_position": 2, "column_position": 3, "cell_value": "V2" }, { "table_number": 1, "row_position": 2, "column_position": 4, "cell_value": "P3" }, { "table_number": 1, "row_position": 2, "column_position": 5, "cell_value": "V4" }, { "table_number": 1, "row_position": 2, "column_position": 6, "cell_value": "P5" }, { "table_number": 1, "row_position": 2, "column_position": 7, "cell_value": "V6" }, { "table_number": 1, "row_position": 2, "column_position": 8, "cell_value": "P7" }, { "table_number": 1, "row_position": 2, "column_position": 9, "cell_value": "V8" }, { "table_number": 1, "row_position": 2, "column_position": 10, "cell_value": "P9" }, { "table_number": 1, "row_position": 2, "column_position": 11, "cell_value": "V10" }, { "table_number": 1, "row_position": 2, "column_position": 12, "cell_value": "P11" }, { "table_number": 1, "row_position": 2, "column_position": 13, "cell_value": "V12" }, { "table_number": 1, "row_position": 2, "column_position": 14, "cell_value": "V13" }, { "table_number": 1, "row_position": 2, "column_position": 15, "cell_value": "V14" }, { "table_number": 1, "row_position": 2, "column_position": 16, "cell_value": "P15" }, { "table_number": 1, "row_position": 2, "column_position": 17, "cell_value": "V16" }, { "table_number": 1, "row_position": 2, "column_position": 18, "cell_value": "P17" }, { "table_number": 1, "row_position": 2, "column_position": 19, "cell_value": "V18" }, { "table_number": 1, "row_position": 2, "column_position": 20, "cell_value": "P19" }, { "table_number": 1, "row_position": 2, "column_position": 21, "cell_value": "V20" }, { "table_number": 1, "row_position": 2, "column_position": 22, "cell_value": "P21" }, { "table_number": 1, "row_position": 2, "column_position": 23, "cell_value": "V22" }, { "table_number": 1, "row_position": 2, "column_position": 24, "cell_value": "P23" }, { "table_number": 1, "row_position": 2, "column_position": 25, "cell_value": "V24" }, { "table_number": 1, "row_position": 2, "column_position": 26, "cell_value": "V25" }, { "table_number": 1, "row_position": 3, "column_position": 2, "cell_value": "-1" }, { "table_number": 1, "row_position": 3, "column_position": 3, "cell_value": "0" }, { "table_number": 1, "row_position": 3, "column_position": 4, "cell_value": "2" }, { "table_number": 1, "row_position": 3, "column_position": 5, "cell_value": "4" }, { "table_number": 1, "row_position": 3, "column_position": 6, "cell_value": "6" }, { "table_number": 1, "row_position": 3, "column_position": 7, "cell_value": "8" }, { "table_number": 1, "row_position": 3, "column_position": 8, "cell_value": "10" }, { "table_number": 1, "row_position": 3, "column_position": 9, "cell_value": "12" }, { "table_number": 1, "row_position": 3, "column_position": 10, "cell_value": "14" }, { "table_number": 1, "row_position": 3, "column_position": 11, "cell_value": "16" }, { "table_number": 1, "row_position": 3, "column_position": 12, "cell_value": "18" }, { "table_number": 1, "row_position": 3, "column_position": 13, "cell_value": "20" }, { "table_number": 1, "row_position": 3, "column_position": 14, "cell_value": "24" }, { "table_number": 1, "row_position": 3, "column_position": 15, "cell_value": "28" }, { "table_number": 1, "row_position": 3, "column_position": 16, "cell_value": "32" }, { "table_number": 1, "row_position": 3, "column_position": 17, "cell_value": "36" }, { "table_number": 1, "row_position": 3, "column_position": 18, "cell_value": "40" }, { "table_number": 1, "row_position": 3, "column_position": 19, "cell_value": "44" }, { "table_number": 1, "row_position": 3, "column_position": 20, "cell_value": "48" }, { "table_number": 1, "row_position": 3, "column_position": 21, "cell_value": "52" }, { "table_number": 1, "row_position": 3, "column_position": 22, "cell_value": "56" }, { "table_number": 1, "row_position": 3, "column_position": 23, "cell_value": "60" }, { "table_number": 1, "row_position": 3, "column_position": 24, "cell_value": "64" }, { "table_number": 1, "row_position": 3, "column_position": 25, "cell_value": "68" }, { "table_number": 1, "row_position": 3, "column_position": 26, "cell_value": "75" }, { "table_number": 1, "row_position": 4, "column_position": 2, "cell_value": "-7 to 0" }, { "table_number": 1, "row_position": 4, "column_position": 3, "cell_value": "0" }, { "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": 4, "column_position": 11, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 12, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 13, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 14, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 15, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 16, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 17, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 18, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 19, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 20, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 21, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 22, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 23, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 24, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 25, "cell_value": "±3" }, { "table_number": 1, "row_position": 4, "column_position": 26, "cell_value": "0 to +5" } ], "activities": [ { "table_number": 1, "row_position": 5, "source_page": 8, "activity_name": "SUBJECT RELATED INFORMATION AND ASSESSMENTS", "activity_name_source": { "cell_text": "SUBJECT RELATED INFORMATION AND ASSESSMENTS", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 6, "source_page": 8, "activity_name": "Informed consent and Demography", "activity_name_source": { "cell_text": "Informed consent and Demographyᵃ (Appendix 3)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "a,pr1" }, { "table_number": 1, "row_position": 7, "source_page": 8, "activity_name": "Childbearing potential", "activity_name_source": { "cell_text": "Childbearing potentialᵇ (Appendix 5)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "b,pr2" }, { "table_number": 1, "row_position": 8, "source_page": 8, "activity_name": "Inclusion criteria", "activity_name_source": { "cell_text": "Inclusion criteria (6.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr3" }, { "table_number": 1, "row_position": 9, "source_page": 8, "activity_name": "Exclusion criteria", "activity_name_source": { "cell_text": "Exclusion criteria (6.2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr4" }, { "table_number": 1, "row_position": 10, "source_page": 8, "activity_name": "Run-in criteria", "activity_name_source": { "cell_text": "Run-in criteria (6.3.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr5" }, { "table_number": 1, "row_position": 11, "source_page": 8, "activity_name": "Randomisation criteria and randomisation", "activity_name_source": { "cell_text": "Randomisation criteria and randomisationᶜ (6.3.2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "c,pr6" }, { "table_number": 1, "row_position": 12, "source_page": 8, "activity_name": "Medical history/Concomitant illness", "activity_name_source": { "cell_text": "Medical history/Concomitant illness (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 13, "source_page": 8, "activity_name": "Weight History", "activity_name_source": { "cell_text": "Weight History (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 14, "source_page": 8, "activity_name": "History of Gallbladder Disease", "activity_name_source": { "cell_text": "History of Gallbladder Disease (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 15, "source_page": 8, "activity_name": "History of Breast Neoplasm", "activity_name_source": { "cell_text": "History of Breast Neoplasmᵇ (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "b,pr7" }, { "table_number": 1, "row_position": 16, "source_page": 8, "activity_name": "History of Colon Neoplasm", "activity_name_source": { "cell_text": "History of Colon Neoplasm (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 17, "source_page": 8, "activity_name": "History of Skin Cancer", "activity_name_source": { "cell_text": "History of Skin Cancer (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 18, "source_page": 8, "activity_name": "History of Psychiatric Disorder", "activity_name_source": { "cell_text": "History of Psychiatric Disorder (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 19, "source_page": 8, "activity_name": "Tobacco Use", "activity_name_source": { "cell_text": "Tobacco Useᵈ", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "d" }, { "table_number": 1, "row_position": 20, "source_page": 8, "activity_name": "Concomitant medication", "activity_name_source": { "cell_text": "Concomitant medication (7.7)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr9" }, { "table_number": 1, "row_position": 21, "source_page": 8, "activity_name": "Trial product compliance", "activity_name_source": { "cell_text": "Trial product compliance (7.1, 7.6)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr10,pr11" }, { "table_number": 1, "row_position": 22, "source_page": 9, "activity_name": "Evaluation of lipid-lowering treatment", "activity_name_source": { "cell_text": "Evaluation of lipid-lowering treatment (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 23, "source_page": 9, "activity_name": "Evaluation of antihypertensive treatment", "activity_name_source": { "cell_text": "Evaluation of antihypertensive treatment (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 24, "source_page": 9, "activity_name": "Evaluation of glycaemic status", "activity_name_source": { "cell_text": "Evaluation of glycaemic status (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 25, "source_page": 9, "activity_name": "EFFICACY", "activity_name_source": { "cell_text": "EFFICACY", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 26, "source_page": 9, "activity_name": "Body measurements", "activity_name_source": { "cell_text": "Body measurements (9.1.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr12" }, { "table_number": 1, "row_position": 27, "source_page": 9, "activity_name": "Height", "activity_name_source": { "cell_text": " Height", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 28, "source_page": 9, "activity_name": "Body Weight", "activity_name_source": { "cell_text": " Body Weight", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 29, "source_page": 9, "activity_name": "Waist Circumference", "activity_name_source": { "cell_text": " Waist Circumference", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 30, "source_page": 9, "activity_name": "HbA1c", "activity_name_source": { "cell_text": "HbA1c", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 31, "source_page": 9, "activity_name": "Fasting plasma glucose", "activity_name_source": { "cell_text": "Fasting plasma glucose", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 32, "source_page": 9, "activity_name": "Fasting serum insulin", "activity_name_source": { "cell_text": "Fasting serum insulin", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 33, "source_page": 9, "activity_name": "Lipids", "activity_name_source": { "cell_text": "Lipids (Appendix 2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr13" }, { "table_number": 1, "row_position": 34, "source_page": 9, "activity_name": "Vital Signs", "activity_name_source": { "cell_text": "Vital Signs (6.4.2, 9.4.3)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr14,pr15" }, { "table_number": 1, "row_position": 35, "source_page": 9, "activity_name": "Systolic Blood Pressure", "activity_name_source": { "cell_text": " Systolic Blood Pressure", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 36, "source_page": 9, "activity_name": "Diastolic Blood Pressure", "activity_name_source": { "cell_text": " Diastolic Blood Pressure", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 37, "source_page": 9, "activity_name": "Clinical Outcome Assessments", "activity_name_source": { "cell_text": "Clinical Outcome Assessments (9.1.2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr16" }, { "table_number": 1, "row_position": 38, "source_page": 9, "activity_name": "Short Form-36 (SF-36)", "activity_name_source": { "cell_text": " Short Form-36 (SF-36)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 39, "source_page": 9, "activity_name": "Weight Related Sign and Symptom Measure (WRSSM)", "activity_name_source": { "cell_text": " Weight Related Sign and Symptom Measure (WRSSM)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 40, "source_page": 9, "activity_name": "Patient Global Impression of Severity (PGI-S)", "activity_name_source": { "cell_text": " Patient Global Impression of Severity (PGI-S)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 41, "source_page": 10, "activity_name": "Patient Global Impression of Change (PGI-C)", "activity_name_source": { "cell_text": " Patient Global Impression of Change (PGI-C)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 42, "source_page": 10, "activity_name": "Stanford Presenteeism Scale (SPS-6)", "activity_name_source": { "cell_text": " Stanford Presenteeism Scale (SPS-6)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 43, "source_page": 10, "activity_name": "SAFETY", "activity_name_source": { "cell_text": "SAFETY", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 44, "source_page": 10, "activity_name": "Physical examination", "activity_name_source": { "cell_text": "Physical examination (9.4.2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr17" }, { "table_number": 1, "row_position": 45, "source_page": 10, "activity_name": "Pregnancy test", "activity_name_source": { "cell_text": "Pregnancy test (9.4.5, Appendix 5)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr18,pr2" }, { "table_number": 1, "row_position": 46, "source_page": 10, "activity_name": "ECG", "activity_name_source": { "cell_text": "ECG (9.4.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr19" }, { "table_number": 1, "row_position": 47, "source_page": 10, "activity_name": "Adverse event", "activity_name_source": { "cell_text": "Adverse event (9.2, Appendix 4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr20,pr21" }, { "table_number": 1, "row_position": 48, "source_page": 10, "activity_name": "Technical complaint", "activity_name_source": { "cell_text": "Technical complaint (9.2.9, Appendix 6)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr22,pr23" }, { "table_number": 1, "row_position": 49, "source_page": 10, "activity_name": "Breast neoplasms follow-up", "activity_name_source": { "cell_text": "Breast neoplasms follow-upᵇ (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "b,pr7" }, { "table_number": 1, "row_position": 50, "source_page": 10, "activity_name": "Colon neoplasms follow-up", "activity_name_source": { "cell_text": "Colon neoplasms follow-up (9.4)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr7" }, { "table_number": 1, "row_position": 51, "source_page": 10, "activity_name": "Haematology", "activity_name_source": { "cell_text": "Haematology (Appendix 2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr13" }, { "table_number": 1, "row_position": 52, "source_page": 10, "activity_name": "Biochemistry", "activity_name_source": { "cell_text": "Biochemistry (Appendix 2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr13" }, { "table_number": 1, "row_position": 53, "source_page": 10, "activity_name": "Vital Signs", "activity_name_source": { "cell_text": "Vital Signs (6.4.2, 9.4.3)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr14,pr15" }, { "table_number": 1, "row_position": 54, "source_page": 10, "activity_name": "Pulse", "activity_name_source": { "cell_text": " Pulse", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 55, "source_page": 10, "activity_name": "Clinical Outcome Assessments", "activity_name_source": { "cell_text": "Clinical Outcome Assessments (9.4.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr24" }, { "table_number": 1, "row_position": 56, "source_page": 10, "activity_name": "Patient Health Questionnaire – 9 (PHQ-9)", "activity_name_source": { "cell_text": " Patient Health Questionnaire – 9 (PHQ-9)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 57, "source_page": 10, "activity_name": "Columbia Suicide Severity Rating Scale (C-SSRS)", "activity_name_source": { "cell_text": " Columbia Suicide Severity Rating Scale (C-SSRS)", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 58, "source_page": 10, "activity_name": "TRIAL MATERIAL", "activity_name_source": { "cell_text": "TRIAL MATERIAL", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 59, "source_page": 10, "activity_name": "First date on trial product", "activity_name_source": { "cell_text": "First date on trial product", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 60, "source_page": 11, "activity_name": "IWRS session", "activity_name_source": { "cell_text": "IWRS session", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 61, "source_page": 11, "activity_name": "Administration of trial product", "activity_name_source": { "cell_text": "Administration of trial product (7.1, 7.5)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr10,pr25" }, { "table_number": 1, "row_position": 62, "source_page": 11, "activity_name": "Dispensing visit", "activity_name_source": { "cell_text": " Dispensing visit", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 63, "source_page": 11, "activity_name": "Drug accountability", "activity_name_source": { "cell_text": " Drug accountability", "indentation_level": 2, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 64, "source_page": 11, "activity_name": "REMINDERS", "activity_name_source": { "cell_text": "REMINDERS", "indentation_level": 0, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 65, "source_page": 11, "activity_name": "Criteria for discontinuation", "activity_name_source": { "cell_text": "Criteria for discontinuation (8.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr26" }, { "table_number": 1, "row_position": 66, "source_page": 11, "activity_name": "Barriers and motivation interview", "activity_name_source": { "cell_text": "Barriers and motivation interview (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 67, "source_page": 11, "activity_name": "Diet and physical activity counselling", "activity_name_source": { "cell_text": "Diet and physical activity counselling (7.1.2)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr27" }, { "table_number": 1, "row_position": 68, "source_page": 11, "activity_name": "Training in trial product, pen-handling", "activity_name_source": { "cell_text": "Training in trial product, pen-handling (7.1.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr28" }, { "table_number": 1, "row_position": 69, "source_page": 11, "activity_name": "Hand out direction for use", "activity_name_source": { "cell_text": "Hand out direction for use (7.1.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr28" }, { "table_number": 1, "row_position": 70, "source_page": 11, "activity_name": "Hand out dose reminder card", "activity_name_source": { "cell_text": "Hand out dose reminder card (7.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr10" }, { "table_number": 1, "row_position": 71, "source_page": 11, "activity_name": "Hand out and instruct in food diary", "activity_name_source": { "cell_text": "Hand out and instruct in food diary (9)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr8" }, { "table_number": 1, "row_position": 72, "source_page": 11, "activity_name": "Hand out ID card", "activity_name_source": { "cell_text": "Hand out ID card", "indentation_level": 1, "indentation_method": "visual_estimate" } }, { "table_number": 1, "row_position": 73, "source_page": 11, "activity_name": "Attend visit fasting", "activity_name_source": { "cell_text": "Attend visit fasting (6.4.1)", "indentation_level": 1, "indentation_method": "visual_estimate" }, "annotation_markers": "pr29" } ], "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": 9, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 10, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 11, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 12, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 13, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 14, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 15, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 16, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 17, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 18, "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": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 12, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 20, "column_position": 25, "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": 21, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 12, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 21, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 22, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 22, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 23, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 23, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 24, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 27, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 28, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "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": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 29, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 30, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 30, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 30, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 30, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 30, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 31, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 32, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 32, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 32, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 33, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 33, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 33, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 35, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 36, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 38, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 39, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 40, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 41, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 42, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 42, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 42, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 44, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 44, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 44, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "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": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 45, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 46, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 46, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 46, "column_position": 25, "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": 47, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 12, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 47, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 12, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 48, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 49, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 49, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 50, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 50, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 51, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 51, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 51, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 51, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 52, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 2, "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": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 54, "column_position": 26, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 56, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 57, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 59, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 60, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 62, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 63, "column_position": 25, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 4, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 6, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 8, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 10, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 12, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 65, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 66, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 14, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 16, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 18, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 20, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 22, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 24, "cell_value": "X" }, { "table_number": 1, "row_position": 67, "column_position": 25, "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": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 15, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 17, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 19, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 68, "column_position": 23, "cell_value": "X" }, { "table_number": 1, "row_position": 69, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 70, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 70, "column_position": 5, "cell_value": "X" }, { "table_number": 1, "row_position": 70, "column_position": 7, "cell_value": "X" }, { "table_number": 1, "row_position": 70, "column_position": 9, "cell_value": "X" }, { "table_number": 1, "row_position": 70, "column_position": 11, "cell_value": "X" }, { "table_number": 1, "row_position": 71, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 72, "column_position": 2, "cell_value": "X" }, { "table_number": 1, "row_position": 73, "column_position": 3, "cell_value": "X" }, { "table_number": 1, "row_position": 73, "column_position": 13, "cell_value": "X" }, { "table_number": 1, "row_position": 73, "column_position": 21, "cell_value": "X" }, { "table_number": 1, "row_position": 73, "column_position": 25, "cell_value": "X" } ], "annotations": [ { "annotation_marker": "a", "annotation_type": "footnote", "annotation_text": "Demography consists of date of birth, sex, ethnicity, and race (according to local regulation)", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 6 } ] }, { "annotation_marker": "b", "annotation_type": "footnote", "annotation_text": "For all female subjects", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 7 }, { "table_number": 1, "location_type": "activity_name", "row_position": 15 }, { "table_number": 1, "location_type": "activity_name", "row_position": 49 } ] }, { "annotation_marker": "c", "annotation_type": "footnote", "annotation_text": "If subjects not fulfil randomisation criteria see Section 6.3.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 11 } ] }, { "annotation_marker": "d", "annotation_type": "footnote", "annotation_text": "Smoking is defined as smoking at least one cigarette or equivalent daily", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 19 } ] }, { "annotation_marker": "pr1", "annotation_type": "source_note", "annotation_text": "Appendix 3", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 6, "method": "synthesized" } ] }, { "annotation_marker": "pr2", "annotation_type": "source_note", "annotation_text": "Appendix 5", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 7, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 45, "method": "synthesized" } ] }, { "annotation_marker": "pr3", "annotation_type": "source_note", "annotation_text": "Section 6.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 8, "method": "synthesized" } ] }, { "annotation_marker": "pr4", "annotation_type": "source_note", "annotation_text": "Section 6.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 9, "method": "synthesized" } ] }, { "annotation_marker": "pr5", "annotation_type": "source_note", "annotation_text": "Section 6.3.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 10, "method": "synthesized" } ] }, { "annotation_marker": "pr6", "annotation_type": "source_note", "annotation_text": "Section 6.3.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 11, "method": "synthesized" } ] }, { "annotation_marker": "pr7", "annotation_type": "source_note", "annotation_text": "Section 9.4", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 12, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 14, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 15, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 16, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 17, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 18, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 49, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 50, "method": "synthesized" } ] }, { "annotation_marker": "pr8", "annotation_type": "source_note", "annotation_text": "Section 9", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 13, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 22, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 23, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 24, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 66, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 71, "method": "synthesized" } ] }, { "annotation_marker": "pr9", "annotation_type": "source_note", "annotation_text": "Section 7.7", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 20, "method": "synthesized" } ] }, { "annotation_marker": "pr10", "annotation_type": "source_note", "annotation_text": "Section 7.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 21, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 61, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 70, "method": "synthesized" } ] }, { "annotation_marker": "pr11", "annotation_type": "source_note", "annotation_text": "Section 7.6", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 21, "method": "synthesized" } ] }, { "annotation_marker": "pr12", "annotation_type": "source_note", "annotation_text": "Section 9.1.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 26, "method": "synthesized" } ] }, { "annotation_marker": "pr13", "annotation_type": "source_note", "annotation_text": "Appendix 2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 33, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 51, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 52, "method": "synthesized" } ] }, { "annotation_marker": "pr14", "annotation_type": "source_note", "annotation_text": "Section 6.4.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 34, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 53, "method": "synthesized" } ] }, { "annotation_marker": "pr15", "annotation_type": "source_note", "annotation_text": "Section 9.4.3", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 34, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 53, "method": "synthesized" } ] }, { "annotation_marker": "pr16", "annotation_type": "source_note", "annotation_text": "Section 9.1.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 37, "method": "synthesized" } ] }, { "annotation_marker": "pr17", "annotation_type": "source_note", "annotation_text": "Section 9.4.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 44, "method": "synthesized" } ] }, { "annotation_marker": "pr18", "annotation_type": "source_note", "annotation_text": "Section 9.4.5", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 45, "method": "synthesized" } ] }, { "annotation_marker": "pr19", "annotation_type": "source_note", "annotation_text": "Section 9.4.4", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 46, "method": "synthesized" } ] }, { "annotation_marker": "pr20", "annotation_type": "source_note", "annotation_text": "Section 9.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 47, "method": "synthesized" } ] }, { "annotation_marker": "pr21", "annotation_type": "source_note", "annotation_text": "Appendix 4", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 47, "method": "synthesized" } ] }, { "annotation_marker": "pr22", "annotation_type": "source_note", "annotation_text": "Section 9.2.9", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 48, "method": "synthesized" } ] }, { "annotation_marker": "pr23", "annotation_type": "source_note", "annotation_text": "Appendix 6", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 48, "method": "synthesized" } ] }, { "annotation_marker": "pr24", "annotation_type": "source_note", "annotation_text": "Section 9.4.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 55, "method": "synthesized" } ] }, { "annotation_marker": "pr25", "annotation_type": "source_note", "annotation_text": "Section 7.5", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 61, "method": "synthesized" } ] }, { "annotation_marker": "pr26", "annotation_type": "source_note", "annotation_text": "Section 8.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 65, "method": "synthesized" } ] }, { "annotation_marker": "pr27", "annotation_type": "source_note", "annotation_text": "Section 7.1.2", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 67, "method": "synthesized" } ] }, { "annotation_marker": "pr28", "annotation_type": "source_note", "annotation_text": "Section 7.1.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 68, "method": "synthesized" }, { "table_number": 1, "location_type": "activity_name", "row_position": 69, "method": "synthesized" } ] }, { "annotation_marker": "pr29", "annotation_type": "source_note", "annotation_text": "Section 6.4.1", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 73, "method": "synthesized" } ] } ], "review_items": [ { "id": "D1", "severity": "medium", "location": { "page": 8, "row_positions": [ 5, 6 ] }, "call_made": "Three indentation levels were read from shading and text indent: dark-grey section bands (SUBJECT RELATED..., EFFICACY, SAFETY, TRIAL MATERIAL, REMINDERS) = 0; medium-grey unindented rows = 1; light, indented rows = 2 (children of Body measurements, Vital Signs, Clinical Outcome Assessments, Administration of trial product).", "alternative": "Treat the medium-grey rows as level 0 peers of the section bands (flat two-level reading: only the indented light rows are children).", "report_section": "3.1" }, { "id": "D2", "severity": "medium", "location": { "page": 9, "row_positions": [ 22, 23, 24 ] }, "call_made": "The three \"Evaluation of ...\" rows at the top of page 9 (and PGI-C / SPS-6 at the top of page 10) are read as continuing the group open at the end of the previous page: Evaluation rows under SUBJECT RELATED INFORMATION AND ASSESSMENTS, PGI-C and SPS-6 as level-2 children of Clinical Outcome Assessments (9.1.2).", "alternative": "Treat the rows at the top of pages 9 and 10 as ungrouped rows with no section parent.", "report_section": "3.1" }, { "id": "D3", "severity": "low", "location": { "page": 8, "row_position": 16, "column_position": 2 }, "call_made": "The mark at History of Colon Neoplasm / V1 prints underlined; transcribed as a plain \"X\" (the underline is read as a formatting artefact, like the hyperlink underlines in the label column).", "alternative": "Keep the underline as a distinct glyph/annotation (e.g. cell_value \"X\" with a note that it is underlined in source).", "report_section": "3.3" } ] }