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This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy |
|
| Group 2 | Active Comparator | Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy |
|
| Group 3 | Active Comparator | Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy |
|
| Group 4 | Active Comparator | Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Tablet | Drug | Number of placebo tablets administered orally depends on the arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) | Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained HBsAg Loss With Suppression of HBV DNA for 24 Weeks After the End of Treatment | Proportion of participants with sustained HBsAg loss with suppression of HBV DNA for 24 weeks after the end of treatment | Baseline to 24 weeks after the end of treatment |
| Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm |
| FG001 | Group 2 | Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| FG002 | Group 3 | Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| FG003 | Group 4 | Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects receiving at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) | Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline | All subjects who received at least one dose of study medication | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to 12 weeks |
|
Up to 60 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
This study was a pilot study with a small number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Fulgencio | Romark Laboratories, L.C. | 813-282-8544 | jessica.fulgencio@romark.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2020 | Oct 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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Patients are randomized 1:1:1:1 (12 subjects per group)
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| Nitazoxanide | Drug | Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
|
|
Change in mean Quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline to Day 3, Week 1, Week 2, Week 4, and Week 8 |
| 8 weeks |
| Hepatitis B Surface Antigen (HBsAg) Loss | Proportion of participants with HBsAg loss defined as quantitative HBsAg below the lower limit of quantitation at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | 12 weeks |
| Hepatitis B Surface Antigen (HBsAg) Seroconversion | Proportion of participants with hepatitis B surface antigen (HBsAg) seroconversion defined as HBsAg loss and gain of anti-hepatitis B antibodies at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | 12 weeks |
| Hepatitis B Virus DNA Suppression | Proportion of participants with hepatitis B virus DNA suppression defined as hepatitis B virus DNA below the lower limit of quantitation (20 IU/mL) at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | 12 weeks |
| Change in Fibrosis-4 (FIB-4) Score | Mean change in Fibrosis-4 (FIB-4) score from Baseline to Week 1, Week 2, Week 4, Week 8, and Week 12. FIB-4 score is calculated as (age in years * Aspartate aminotransferase (AST) in U/L)/(platelet count in 10^9 U/L * square root of alanine aminotransferase (ALT) in U/L). FIB-4 scores under 1.45 have a negative predictive value of 90% for advanced fibrosis (better outcome) and FIB-4 scores >3.25 have a positive predictive value of 65% for advanced fibrosis (worse outcome). See Sterling RK, Lissen E, Clumeck N, et. al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV co-infection. Hepatology 2006;43:1317-1325. | 12 weeks |
| Change in FibroScan Score | Mean change in FibroScan score from Baseline to end of treatment. Fibroscan is a kind of liver elastography measuring liver stiffness in kilopascals (kPa). Higher results are consistent with liver disease (worse outcome). | Baseline to end of treatment |
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
| BG002 | Group 3 | Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| BG003 | Group 4 | Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Quantitative HBsAg | Mean | Standard Deviation | log10 IU/mL |
|
| OG002 | Group 3 | Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
| OG003 | Group 4 | Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
|
|
|
| Secondary | Sustained HBsAg Loss With Suppression of HBV DNA for 24 Weeks After the End of Treatment | Proportion of participants with sustained HBsAg loss with suppression of HBV DNA for 24 weeks after the end of treatment | All participants who received at least one dose of study medication | Posted | Count of Participants | Participants | Baseline to 24 weeks after the end of treatment |
|
|
|
|
| Secondary | Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment | Change in mean Quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline to Day 3, Week 1, Week 2, Week 4, and Week 8 | All participants who received at least one dose of study medication | Posted | Mean | Standard Deviation | log10 IU/mL | 8 weeks |
|
|
|
|
| Secondary | Hepatitis B Surface Antigen (HBsAg) Loss | Proportion of participants with HBsAg loss defined as quantitative HBsAg below the lower limit of quantitation at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | All participants who received at least one dose of study medication | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | Hepatitis B Surface Antigen (HBsAg) Seroconversion | Proportion of participants with hepatitis B surface antigen (HBsAg) seroconversion defined as HBsAg loss and gain of anti-hepatitis B antibodies at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | All participants who received at least one dose of study medication | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | Hepatitis B Virus DNA Suppression | Proportion of participants with hepatitis B virus DNA suppression defined as hepatitis B virus DNA below the lower limit of quantitation (20 IU/mL) at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12 | All participants who received at least one dose of study medication | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | Change in Fibrosis-4 (FIB-4) Score | Mean change in Fibrosis-4 (FIB-4) score from Baseline to Week 1, Week 2, Week 4, Week 8, and Week 12. FIB-4 score is calculated as (age in years * Aspartate aminotransferase (AST) in U/L)/(platelet count in 10^9 U/L * square root of alanine aminotransferase (ALT) in U/L). FIB-4 scores under 1.45 have a negative predictive value of 90% for advanced fibrosis (better outcome) and FIB-4 scores >3.25 have a positive predictive value of 65% for advanced fibrosis (worse outcome). See Sterling RK, Lissen E, Clumeck N, et. al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV co-infection. Hepatology 2006;43:1317-1325. | All participants who received at least one dose of study medication | Posted | Mean | Standard Deviation | FIB-4 Score | 12 weeks |
|
|
|
|
| Secondary | Change in FibroScan Score | Mean change in FibroScan score from Baseline to end of treatment. Fibroscan is a kind of liver elastography measuring liver stiffness in kilopascals (kPa). Higher results are consistent with liver disease (worse outcome). | All participants who received at least one dose of study medication | Posted | Mean | Standard Deviation | kilopascals (kPa) | Baseline to end of treatment |
|
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 10 |
| 13 |
| EG001 | Group 2 | Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm | 0 | 13 | 0 | 13 | 10 | 13 |
| EG002 | Group 3 | Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm | 0 | 11 | 0 | 11 | 11 | 11 |
| EG003 | Group 4 | Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm | 1 | 14 | 1 | 14 | 13 | 14 |
| Mixed hepatocellular cholangiocarcinoma | Hepatobiliary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Scleral discolouration | Eye disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Hunger | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA (24.0) | Non-systematic Assessment |
|
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
|
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| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Superiority |
| Fisher Exact | 1.000 | Superiority |
| Week 1 |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| 1.000 |
| Superiority |
| Comparison of Week 2 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Day 3 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 1 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 2 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 0.001 | Superiority |
| Comparison of Day 3 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 1 values | t-test, 2 sided | 1.000 | Superiority |
| Comparison of Week 2 values | t-test, 2 sided | <0.001 | Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 0.002 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 1.000 | Superiority |
| Week 1 |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| 1.000 |
| Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Week 1 |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| 1.000 |
| Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Week 1 |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| 1.000 |
| Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Day 3 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 1 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 2 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 4 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 8 values | Fisher Exact | 1.000 | Superiority |
| Comparison of Week 12 values | Fisher Exact | 1.000 | Superiority |
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| 0.003 |
| Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 0.004 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 0.006 | Superiority |
| Comparison of Week 12 values | t-test, 2 sided | 0.002 | Superiority |
| Comparison of Week 1 values | t-test, 2 sided | 0.141 | Superiority |
| Comparison of Week 2 values | t-test, 2 sided | 0.081 | Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 0.160 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 0.184 | Superiority |
| Comparison of Week 12 values | t-test, 2 sided | 0.046 | Superiority |
| Comparison of Week 1 values | t-test, 2 sided | 0.379 | Superiority |
| Comparison of Week 2 values | t-test, 2 sided | 0.308 | Superiority |
| Comparison of Week 4 values | t-test, 2 sided | 0.794 | Superiority |
| Comparison of Week 8 values | t-test, 2 sided | 0.297 | Superiority |
| Comparison of Week 12 values | t-test, 2 sided | 0.007 | Superiority |
| Superiority |
| t-test, 2 sided | 0.266 | Superiority |