data/raw/validation_tracker_study2_dr2.bundle.json

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        "Date Validation Completed (YYYY-MM-DD)": null,
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Program Name": "TV",
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": null,
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-09",
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        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-11",
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        "Delivery Notes": "See Comment tracker.",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-08",
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-12",
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        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Validation Programmer Name": null,
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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        "Output Type (Table, Listing, Figure)": "Table",
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        "Production Status": "Ready for QC",
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        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-09",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.5",
        "Title": "Demographics (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.6",
        "Title": "Baseline characteristics (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.7",
        "Title": "Asthma characteristics at study entry (Safety Analysis Set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.8",
        "Title": "Medical history by system organ class and preferred term (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.9",
        "Title": "Surgical history by system organ class and preferred term (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.10",
        "Title": "Prior medication by ATC classification and generic drug name (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": "Comments added to the \"Comment Tracker\".",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.11",
        "Title": "Concomitant medication by ATC classification and generic drug name (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.12",
        "Title": "Disallowed concomitant medication by ATC classification and generic drug name (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.1.13",
        "Title": "Study treatment compliance (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-12",
        "Validation Status": "Pass",
        "Delivery Notes": "Commet added to the \"Comment Tracker\"",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.1.2.2",
        "Title": "Statistical assessment of change from baseline to day 29 in peak FEV1 (mL) (Supplementary analysis set for equivalence, Hybrid strategy estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "On Hold",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.2.1.1",
        "Title": "Change from baseline to day 29 in trough FEV1 (mL) (Primary analysis set for equivalence of trough FEV1, Principal stratum estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-09",
        "Validation Status": "Pass",
        "Delivery Notes": "Baseline and change matched but not Day 29 (greater n than baseline and change) because those without a baseline are included in Day 29.",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.3.3.2",
        "Title": "Statistical assessment of change from baseline to day 29 in trough FEV1 (mL) (Primary analysis set for assay sensitivity of trough FEV1, Principal stratum estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": "Got the same results after removing certain data. See comment tracker for details.",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.3.4.1",
        "Title": "Change from baseline to day 29 in trough FEV1 (mL) (Supplementary analysis set for assay sensitivity, Hybrid strategy estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "On Hold",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.3.4.2",
        "Title": "Statistical assessment of change from baseline to day 29 in trough FEV1 (mL) (Supplementary analysis set for assay sensitivity, Hybrid strategy estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "On Hold",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.4.1.1",
        "Title": "Change from baseline to day 29 in peak FEV1 (mL) (Exploratory analysis set for superiority of BDA MDI HFO over Placebo MDI HFA for peak FEV1, Principal Stratum Estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.4.1.2",
        "Title": "Statistical assessment of change from baseline to day 29 in peak FEV1 (mL) (Exploratory analysis set for superiority of BDA MDI HFO over Placebo MDI HFA for peak FEV1, Principal stratum estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": "Got the same results after removing certain data. See comment tracker for details.",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.4.2.1",
        "Title": "Change from baseline to day 29 in trough FEV1 (mL) (Exploratory analysis set for superiority of BDA MDI HFO over Placebo MDI HFA for trough FEV1, Principal stratum estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.2.4.2.2",
        "Title": "Statistical assessment of change from baseline to Day 29 in trough FEV1 (mL) (Exploratory analysis set for superiority of BDA MDI HFO over Placebo MDI HFA for trough FEV1, Principal stratum estimand)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Repeat",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": "Got the same results after removing certain data. See comment tracker for details.",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.1",
        "Title": "Duration of exposure (days) (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": "v_t140301.sas",
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-09",
        "Validation Status": "Pass",
        "Delivery Notes": "Mismatch due to data issue. Comments are added to the \"Comment Tracker\"",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.2.1",
        "Title": "Overall summary of adverse events – subject count (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "H",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.2.2",
        "Title": "Adverse events by system organ class and preferred term (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": null,
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-11",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.2.3",
        "Title": "Adverse events sorted by decreasing frequency on preferred term level (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": null,
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-12",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.2.4",
        "Title": "Adverse events at or above reporting threshold of 2% by preferred term (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": null,
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-12",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
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        "Program Name": null,
        "Output Name": null,
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        "Test Method": null,
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.2.7",
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        "Program Name": null,
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
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        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.3.1",
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
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        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.4.2",
        "Title": "Serious adverse events – Key subject information (Safety analysis set)",
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        "Program Name": null,
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.5.1",
        "Title": "Adverse events leading to discontinuation of investigational product by system organ class and preferred term (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": null,
        "Program Name": null,
        "Output Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.5.2",
        "Title": "Adverse events leading to discontinuation of investigational product – Key subject information (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
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        "Output Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": null,
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.6.1",
        "Title": "Subjects with asthma exacerbations (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": null,
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.6.2",
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        "Output Kind (Unique, Repeat)": null,
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        "Output Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.7.1",
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        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "On Hold",
        "Delivery Notes": "comments added in the tracker",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.7.2",
        "Title": "Vital sign shift from baseline to maximum on-treatment value (Safety analysis set)",
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        "Program Name": null,
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.7.3",
        "Title": "Vital sign shift from baseline to minimum on-treatment value (Safety analysis set)",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.7.4",
        "Title": "Treatment-emergent vital sign abnormalities by predefined criteria – Key subject information (Safety analysis set)",
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        "Program Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Table",
        "Output #": "14.3.7.5",
        "Title": "Treatment-emergent vital sign abnormalities by predefined criteria – on-treatment (Safety analysis set)",
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        "Program Name": null,
        "Output Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Ved Prakash (kwhq666)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-15",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Output Kind (Unique, Repeat)": "Unique",
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        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
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        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Claire Springett (kwpl977)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": "Comments added to the \"Comment Tracker\".",
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Title": "Subjects with important protocol deviations (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
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        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Ved Prakash (kwhq666)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Title": "Subjects excluded from any analysis set (Randomised analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
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        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-10",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Title": "Demographic and baseline characteristics (Safety analysis set)",
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        "Output Name": null,
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Title": "Exposure to investigational product (Safety analysis set)",
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        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
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        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
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      {
        "Output Type (Table, Listing, Figure)": "Listing",
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        "Title": "Assessment of FEV1 (Randomised analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
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        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Claire Springett (kwpl977)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-04",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
        "Output #": "16.3.1",
        "Title": "Adverse events (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
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        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Ved Prakash (kwhq666)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": "2025-09-12",
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
        "Output #": "16.4.1",
        "Title": "Safety laboratory tests (Safety analysis set)",
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        "Output Kind (Unique, Repeat)": "Unique",
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        "Output Name": null,
        "Risk Level (H, M, L)": "L",
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        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Sayantan Basu (kjbz146)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      },
      {
        "Output Type (Table, Listing, Figure)": "Listing",
        "Output #": "16.5.1",
        "Title": "12-lead electrocardiogram (Safety analysis set)",
        "Standard Template Reference": null,
        "Output Kind (Unique, Repeat)": "Unique",
        "Program Name": null,
        "Output Name": null,
        "Risk Level (H, M, L)": "L",
        "Test Method": null,
        "Additional Test Information": null,
        "Included in delivery": "Y",
        "Production Programmer Name": "Clinchoice",
        "Projected Completion Date": "2025-08-29",
        "Production Status": "Ready for QC",
        "Date ready for QC (YYYY-MM-DD)": "2025-08-29",
        "Validation Program (if any)": null,
        "Validation Programmer Name": "Sayantan Basu (kjbz146)",
        "Val Projected Date": "2025-09-15",
        "Date Validation Completed (YYYY-MM-DD)": null,
        "Validation Status": "Pass",
        "Delivery Notes": null,
        "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null
      }
    ]
  }
}