Psoriatic Arthritis
Conditions
Keywords
Psoriatic Arthritis, PsA, Bimekizumab
Brief summary
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
Interventions
OTHERPlacebo
DRUGBimekizumab
Bimekizumab in different dosage regimens.
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) \>=3 out of 78 and swollen joint count (SJC) \>=3 out of 76 * Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative * Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis * Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline * Subjects taking corticosteroids must be on an average daily dose of \<=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit * Subjects taking methotrexate (MTX) (\<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization * Subjects taking leflunomide (LEF; \<=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16 * Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have: 1. experienced an inadequate response to previous treatment given for at least 3 months 2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation) 3. lost access to TNF inhibitor for other reasons
Exclusion criteria
* Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1 * Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit * Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis * Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline * Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection * Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis * Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included: 1. \<= 3 excised or ablated basal cell carcinomas of the skin 2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening 3. Actinic keratosis (-es) 4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | Week 12 | The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | Week 12 | The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis. |
| PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | Week 12 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | Week 12 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. |
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
| Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48 | Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg). |
| Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48 | Pulse rate was measured in beats per minute (beats/min). |
| Changes From Baseline in Body Weight During the Study | Baseline, Week 12, Week 24, Week 36 and Week 48 | Body weight was measured in kilograms. |
| Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | Baseline, Week 12 and Week 48 | Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds. |
| Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10\^9/L). |
| Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L). |
| ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | Week 12 | The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis. |
| Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Erythrocytes mean corpuscular volume was measured in femtolitres (fL). |
| Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Erythrocytes was measured in number of red blood cells per liter (10\^12/L). |
| Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Hematocrit was measured in volume percentage (%) of red blood cells in blood. |
| Changes From Baseline in Hematology Parameters During the Study (Platelets) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Platelets was measured in number of platelets per liter (10\^9/L). |
| Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L). |
| Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Albumin was measured in grams per liter (g/L). |
| Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L). |
| Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L). |
| Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Urea nitrogen was measured in millimoles per liter (mmol/L). |
| Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF). |
| Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Hyaline casts was measured in cells per low power field (cells/LPF). |
| Changes From Baseline in Urinalysis Parameters During the Study (pH) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Urine pH was measured on a pH scale. |
| Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). |
Countries
Czechia, Germany, Hungary, Poland, Russia, United States
Participant flow
Recruitment details
The study started to enroll patients in October 2016 and concluded in July 2018.
Pre-assignment details
The study included a 28-Day Screening Period, followed by a Double-blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post week 48. The Participant Flow refers to the Randomized Set and Dose-Blind Set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received Placebo during the 12 Weeks Double-Blind Period. | 42 |
| BKZ 16 mg Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | 41 |
| BKZ 160 mg Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | 41 |
| BKZ 160 mg LD Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | 41 |
| BKZ 320 mg Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | 41 |
| Total Title | 206 |
| Total | 412 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose-Blind Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Dose-Blind Period | Non-cooperating patient | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Dose-Blind Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 0 |
| Dose-Blind Period | Withdrew before Safety Follow-up visit | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Double-Blind Period | Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Period | LOW EGFR | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Period | Study medication discontinued prior Wk12 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 1 Participants | 5 Participants | 5 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 35 Participants | 40 Participants | 36 Participants | 36 Participants | 185 Participants |
| Age, Continuous | 49.02 years STANDARD_DEVIATION 12.07 | 49.98 years STANDARD_DEVIATION 13.56 | 48.00 years STANDARD_DEVIATION 11.65 | 49.05 years STANDARD_DEVIATION 12.99 | 50.39 years STANDARD_DEVIATION 12.08 | 49.29 years STANDARD_DEVIATION 12.39 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 40 Participants | 39 Participants | 40 Participants | 41 Participants | 200 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 21 Participants | 27 Participants | 18 Participants | 101 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 20 Participants | 14 Participants | 23 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 39 | 0 / 126 | 0 / 80 |
| other Total, other adverse events | 8 / 42 | 9 / 39 | 40 / 126 | 29 / 80 |
| serious Total, serious adverse events | 1 / 42 | 0 / 39 | 8 / 126 | 0 / 80 |
Outcome results
Primary
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Time frame: Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 7.1 percentage of subjects |
| BKZ 16 mg (FAS) | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 26.8 percentage of subjects |
| BKZ 160 mg (FAS) | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 41.5 percentage of subjects |
| BKZ 160 mg LD (FAS) | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 46.3 percentage of subjects |
| BKZ 320 mg (FAS) | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 24.4 percentage of subjects |
Comparison: Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response.p-value: =0.031Cochran-Mantel-Haenszel
Comparison: For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.p-value: =0.03295% CI: [1.13, 15.23]Regression, Logistic
Comparison: For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.p-value: =0.00195% CI: [2.28, 28.74]Regression, Logistic
Comparison: For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.p-value: <0.00195% CI: [2.73, 34.26]Regression, Logistic
Comparison: For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.p-value: =0.05195% CI: [1, 13.68]Regression, Logistic
Secondary
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time frame: Week 12
Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 19.0 percentage of subjects |
| BKZ 16 mg (FAS) | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 53.7 percentage of subjects |
| BKZ 160 mg (FAS) | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 73.2 percentage of subjects |
| BKZ 160 mg LD (FAS) | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 61.0 percentage of subjects |
| BKZ 320 mg (FAS) | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 51.2 percentage of subjects |
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.00295% CI: [1.73, 12.39]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: <0.00195% CI: [3.91, 30.95]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: <0.00195% CI: [2.31, 16.84]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.00495% CI: [1.59, 11.35]Regression, Logistic
Secondary
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time frame: Week 12
Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 4.8 percentage of subjects |
| BKZ 16 mg (FAS) | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 12.2 percentage of subjects |
| BKZ 160 mg (FAS) | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 19.5 percentage of subjects |
| BKZ 160 mg LD (FAS) | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 31.7 percentage of subjects |
| BKZ 320 mg (FAS) | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 14.6 percentage of subjects |
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.27995% CI: [0.5, 11.31]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.06595% CI: [0.92, 17.88]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.00695% CI: [1.77, 31.28]Regression, Logistic
Comparison: For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.p-value: =0.17295% CI: [0.63, 13.39]Regression, Logistic
Secondary
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 32 | -1.385 U/L | Standard Deviation 12.2895 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 8 | -1.829 U/L | Standard Deviation 5.9745 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 8 | -3.537 U/L | Standard Deviation 10.5477 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 4 | -0.220 U/L | Standard Deviation 7.2129 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 12 | -3.049 U/L | Standard Deviation 12.2106 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 28 | -3.385 U/L | Standard Deviation 17.7373 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 1 | 0.171 U/L | Standard Deviation 5.4447 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 16 | -1.048 U/L | Standard Deviation 12.1313 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 44 | -0.757 U/L | Standard Deviation 32.2847 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 48 | 2.158 U/L | Standard Deviation 9.7939 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 20 | 6.375 U/L | Standard Deviation 60.1309 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 44 | 2.838 U/L | Standard Deviation 15.4641 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 24 | 1.718 U/L | Standard Deviation 23.794 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 1 | -1.098 U/L | Standard Deviation 6.0034 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 40 | 0.946 U/L | Standard Deviation 12.1494 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 28 | -1.179 U/L | Standard Deviation 13.4905 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 36 | 0.711 U/L | Standard Deviation 7.3113 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 48 | 2.605 U/L | Standard Deviation 14.0646 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 40 | -0.216 U/L | Standard Deviation 34.5214 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 2 | -1.905 U/L | Standard Deviation 6.796 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 24 | -1.564 U/L | Standard Deviation 19.4974 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 36 | 0.553 U/L | Standard Deviation 37.3889 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 4 | -1.634 U/L | Standard Deviation 9.063 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 32 | -6.333 U/L | Standard Deviation 23.0587 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 8 | -2.220 U/L | Standard Deviation 8.3711 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 12 | -4.220 U/L | Standard Deviation 15.1765 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 28 | 1.436 U/L | Standard Deviation 21.1122 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 12 | -2.463 U/L | Standard Deviation 8.8122 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 32 | -4.487 U/L | Standard Deviation 16.54 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 24 | 4.462 U/L | Standard Deviation 31.9282 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 16 | -8.357 U/L | Standard Deviation 12.7276 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 20 | 1.200 U/L | Standard Deviation 35.1817 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 20 | -10.425 U/L | Standard Deviation 14.051 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 8 | -4.707 U/L | Standard Deviation 13.6478 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 16 | 0.881 U/L | Standard Deviation 26.018 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 28 | -12.795 U/L | Standard Deviation 16.9351 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 36 | 0.579 U/L | Standard Deviation 10.5411 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 12 | -0.927 U/L | Standard Deviation 28.3058 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 32 | -13.667 U/L | Standard Deviation 16.187 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 4 | -5.634 U/L | Standard Deviation 25.5693 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 36 | -11.816 U/L | Standard Deviation 19.2436 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 2 | -5.929 U/L | Standard Deviation 18.4858 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 40 | -11.000 U/L | Standard Deviation 16.9706 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 44 | -12.622 U/L | Standard Deviation 17.6373 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 4 | -3.854 U/L | Standard Deviation 15.1897 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 1 | -7.000 U/L | Standard Deviation 16.1509 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 48 | -12.211 U/L | Standard Deviation 19.0379 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 40 | -0.622 U/L | Standard Deviation 10.2506 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 48 | 1.474 U/L | Standard Deviation 17.6723 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 2 | -1.762 U/L | Standard Deviation 10.5294 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 20 | 0.300 U/L | Standard Deviation 39.9482 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 44 | 2.649 U/L | Standard Deviation 19.7993 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 44 | 1.081 U/L | Standard Deviation 23.2108 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 40 | -2.568 U/L | Standard Deviation 9.3676 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 24 | -12.795 U/L | Standard Deviation 15.4752 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 36 | -0.026 U/L | Standard Deviation 14.7162 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 32 | 0.359 U/L | Standard Deviation 15.7872 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 1 | -2.854 U/L | Standard Deviation 10.3212 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 28 | -0.462 U/L | Standard Deviation 11.5618 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 2 | -0.190 U/L | Standard Deviation 5.8736 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 48 | 4.447 U/L | Standard Deviation 34.3493 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 8 | -3.561 U/L | Standard Deviation 17.3249 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 16 | -2.048 U/L | Standard Deviation 18.0026 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 24 | -0.615 U/L | Standard Deviation 12.4173 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 20 | -0.750 U/L | Standard Deviation 9.5051 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 1 | -1.366 U/L | Standard Deviation 12.7451 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 16 | -0.357 U/L | Standard Deviation 9.6445 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 4 | -3.976 U/L | Standard Deviation 10.6642 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 12 | -0.585 U/L | Standard Deviation 5.9033 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 2 | -1.714 U/L | Standard Deviation 15.4624 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 28 | -5.684 U/L | Standard Deviation 15.7259 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 8 | -4.410 U/L | Standard Deviation 11.6319 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 32 | -1.538 U/L | Standard Deviation 13.2463 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 4 | -2.641 U/L | Standard Deviation 9.9167 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 2 | -3.282 U/L | Standard Deviation 7.837 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 8 | -0.077 U/L | Standard Deviation 5.8687 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 48 | 2.216 U/L | Standard Deviation 12.8542 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 8 | 0.026 U/L | Standard Deviation 19.0449 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 1 | -2.737 U/L | Standard Deviation 7.0354 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 40 | -3.842 U/L | Standard Deviation 13.9275 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 12 | 0.436 U/L | Standard Deviation 5.3054 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 32 | -4.769 U/L | Standard Deviation 16.153 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 36 | 0.184 U/L | Standard Deviation 11.866 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 48 | 3.459 U/L | Standard Deviation 6.3403 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 4 | 4.846 U/L | Standard Deviation 21.4372 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 16 | 2.974 U/L | Standard Deviation 8.3649 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 4 | 1.289 U/L | Standard Deviation 7.5584 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 1 | 2.526 U/L | Standard Deviation 15.5211 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 44 | 2.553 U/L | Standard Deviation 7.9175 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 36 | -6.368 U/L | Standard Deviation 15.4735 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 20 | 2.821 U/L | Standard Deviation 6.6367 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 40 | -8.289 U/L | Standard Deviation 17.4896 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 20 | 3.821 U/L | Standard Deviation 13.0139 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 40 | 1.316 U/L | Standard Deviation 5.5269 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 2 | -0.410 U/L | Standard Deviation 14.9045 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 24 | 2.237 U/L | Standard Deviation 6.9182 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 36 | -4.289 U/L | Standard Deviation 11.4559 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 44 | -5.316 U/L | Standard Deviation 21.4805 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 36 | 1.026 U/L | Standard Deviation 5.514 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 40 | -5.658 U/L | Standard Deviation 15.7485 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 28 | 2.289 U/L | Standard Deviation 6.9512 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 1 | -1.342 U/L | Standard Deviation 8.0983 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 4 | 1.553 U/L | Standard Deviation 16.2758 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 32 | 1.949 U/L | Standard Deviation 6.2826 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 12 | -2.154 U/L | Standard Deviation 10.7643 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 28 | 2.658 U/L | Standard Deviation 12.8174 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 44 | -6.421 U/L | Standard Deviation 14.9099 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 36 | -4.658 U/L | Standard Deviation 16.8383 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 20 | -2.769 U/L | Standard Deviation 13.0555 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 1 | 0.026 U/L | Standard Deviation 19.6118 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 1 | 1.447 U/L | Standard Deviation 6.2155 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 48 | -1.395 U/L | Standard Deviation 23.8061 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 4 | -1.077 U/L | Standard Deviation 10.4236 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 12 | 0.359 U/L | Standard Deviation 12.2356 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 32 | -6.410 U/L | Standard Deviation 23.8324 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 48 | -6.500 U/L | Standard Deviation 16.5313 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 28 | -2.132 U/L | Standard Deviation 11.7638 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 8 | 0.308 U/L | Standard Deviation 12.6515 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 48 | -2.184 U/L | Standard Deviation 12.085 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 28 | -4.763 U/L | Standard Deviation 21.2138 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 40 | 0.816 U/L | Standard Deviation 12.668 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 2 | 2.026 U/L | Standard Deviation 8.9428 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 12 | -0.462 U/L | Standard Deviation 12.1066 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 44 | -1.289 U/L | Standard Deviation 21.373 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 24 | 1.333 U/L | Standard Deviation 22.1862 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 24 | -2.769 U/L | Standard Deviation 10.9339 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 2 | 0.487 U/L | Standard Deviation 4.0967 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 16 | -0.895 U/L | Standard Deviation 13.1515 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 24 | 2.789 U/L | Standard Deviation 14.5475 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 20 | 2.154 U/L | Standard Deviation 22.8825 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 16 | 2.684 U/L | Standard Deviation 16.3229 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 16 | -1.842 U/L | Standard Deviation 13.4476 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 20 | -5.410 U/L | Standard Deviation 15.1895 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 8 | -1.385 U/L | Standard Deviation 9.458 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 16 | 15.447 U/L | Standard Deviation 62.0267 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 24 | -4.769 U/L | Standard Deviation 13.8097 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 32 | 2.385 U/L | Standard Deviation 12.8956 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 2 | -2.026 U/L | Standard Deviation 7.6828 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 12 | 4.077 U/L | Standard Deviation 21.0905 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 44 | 1.474 U/L | Standard Deviation 13.1514 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 1 | 2.628 U/L | Standard Deviation 42.1234 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 24 | -5.659 U/L | Standard Deviation 39.6652 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 28 | -3.244 U/L | Standard Deviation 43.4688 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 32 | -4.150 U/L | Standard Deviation 44.0126 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 36 | -2.976 U/L | Standard Deviation 42.9275 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 40 | -2.780 U/L | Standard Deviation 44.9719 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 44 | -3.415 U/L | Standard Deviation 43.2966 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 48 | -4.561 U/L | Standard Deviation 43.1926 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 1 | -2.721 U/L | Standard Deviation 7.2056 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 2 | -4.349 U/L | Standard Deviation 9.5963 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 4 | -3.262 U/L | Standard Deviation 9.9144 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 8 | 1.233 U/L | Standard Deviation 37.8014 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 12 | -5.952 U/L | Standard Deviation 11.0695 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 16 | -7.238 U/L | Standard Deviation 10.7722 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 20 | -10.143 U/L | Standard Deviation 13.0264 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 24 | -9.463 U/L | Standard Deviation 11.3448 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 28 | -11.244 U/L | Standard Deviation 12.6249 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 32 | -10.900 U/L | Standard Deviation 13.0026 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 36 | -11.122 U/L | Standard Deviation 12.3495 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 40 | -11.024 U/L | Standard Deviation 12.918 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 44 | -10.537 U/L | Standard Deviation 13.5759 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 48 | -11.049 U/L | Standard Deviation 14.4827 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 1 | -0.023 U/L | Standard Deviation 27.5409 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 4 | -3.952 U/L | Standard Deviation 38.9546 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 2 | -2.233 U/L | Standard Deviation 26.3266 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 32 | -7.875 U/L | Standard Deviation 36.9103 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 20 | 2.500 U/L | Standard Deviation 31.6145 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 4 | -3.262 U/L | Standard Deviation 25.1047 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 2 | -1.047 U/L | Standard Deviation 41.1223 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 8 | 2.279 U/L | Standard Deviation 34.7805 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 12 | -2.595 U/L | Standard Deviation 22.5324 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 16 | -2.595 U/L | Standard Deviation 24.3852 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 20 | -1.095 U/L | Standard Deviation 25.1317 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 24 | -1.902 U/L | Standard Deviation 26.1054 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 28 | -1.805 U/L | Standard Deviation 27.4583 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 32 | -0.575 U/L | Standard Deviation 28.3177 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 36 | -1.220 U/L | Standard Deviation 25.5798 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 40 | 0.244 U/L | Standard Deviation 29.2701 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 44 | -1.268 U/L | Standard Deviation 28.428 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 48 | -1.927 U/L | Standard Deviation 28.3182 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 1 | -0.535 U/L | Standard Deviation 10.8745 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 2 | -4.116 U/L | Standard Deviation 25.7527 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 4 | -6.143 U/L | Standard Deviation 35.5504 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 8 | 11.581 U/L | Standard Deviation 103.8974 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 12 | -5.762 U/L | Standard Deviation 34.8767 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 16 | -4.357 U/L | Standard Deviation 34.002 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 20 | -5.452 U/L | Standard Deviation 32.197 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 24 | -4.122 U/L | Standard Deviation 36.6832 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 28 | -6.341 U/L | Standard Deviation 36.7434 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 36 | -8.195 U/L | Standard Deviation 38.6899 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 40 | -9.073 U/L | Standard Deviation 40.5792 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 44 | -7.488 U/L | Standard Deviation 34.4145 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 48 | -7.805 U/L | Standard Deviation 35.4924 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 1 | -1.163 U/L | Standard Deviation 33.1669 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 2 | -5.930 U/L | Standard Deviation 32.8325 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 4 | -6.190 U/L | Standard Deviation 29.5265 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 8 | 0.140 U/L | Standard Deviation 38.8413 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 12 | 2.119 U/L | Standard Deviation 27.5134 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 16 | -4.381 U/L | Standard Deviation 35.96 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 24 | 2.878 U/L | Standard Deviation 44.9662 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 28 | -2.902 U/L | Standard Deviation 34.359 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 32 | -4.525 U/L | Standard Deviation 35.2762 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 36 | -7.585 U/L | Standard Deviation 35.0442 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 40 | -6.366 U/L | Standard Deviation 36.6898 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 44 | -5.000 U/L | Standard Deviation 34.6259 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 48 | -4.707 U/L | Standard Deviation 38.6654 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 8 | 5.465 U/L | Standard Deviation 68.0764 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 12 | -4.429 U/L | Standard Deviation 38.1756 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 16 | -4.857 U/L | Standard Deviation 38.6211 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 20 | -4.881 U/L | Standard Deviation 39.1808 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 4 | 8.927 U/L | Standard Deviation 52.066 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 2 | 4.927 U/L | Standard Deviation 20.9623 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 8 | -1.795 U/L | Standard Deviation 5.7454 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 1 | 3.122 U/L | Standard Deviation 10.2791 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 40 | -3.853 U/L | Standard Deviation 11.1059 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 12 | -0.447 U/L | Standard Deviation 8.3785 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 20 | -0.838 U/L | Standard Deviation 11.1118 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 16 | -0.947 U/L | Standard Deviation 8.1868 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 36 | -6.147 U/L | Standard Deviation 21.6895 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 20 | -1.649 U/L | Standard Deviation 5.5137 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 20 | 0.676 U/L | Standard Deviation 20.9206 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 36 | -0.471 U/L | Standard Deviation 11.2848 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 24 | -2.639 U/L | Standard Deviation 9.436 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 40 | -0.647 U/L | Standard Deviation 6.0597 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 2 | 3.805 U/L | Standard Deviation 14.7635 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 28 | -2.629 U/L | Standard Deviation 7.6354 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 32 | -3.676 U/L | Standard Deviation 8.6435 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 40 | -10.559 U/L | Standard Deviation 11.6987 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 48 | -7.441 U/L | Standard Deviation 23.0443 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 36 | -2.735 U/L | Standard Deviation 7.1236 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 2 | -4.805 U/L | Standard Deviation 7.8237 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 40 | -4.088 U/L | Standard Deviation 7.5573 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 44 | -3.882 U/L | Standard Deviation 12.8741 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 4 | 22.756 U/L | Standard Deviation 139.8531 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 44 | -3.824 U/L | Standard Deviation 7.043 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 1 | 2.244 U/L | Standard Deviation 6.7889 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 48 | -7.765 U/L | Standard Deviation 12.329 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 48 | -2.941 U/L | Standard Deviation 8.8247 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 44 | -8.647 U/L | Standard Deviation 10.5483 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 1 | -0.585 U/L | Standard Deviation 16.6673 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 36 | -8.059 U/L | Standard Deviation 9.5217 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 32 | -2.176 U/L | Standard Deviation 12.7742 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 2 | -2.439 U/L | Standard Deviation 19.2146 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 32 | -9.118 U/L | Standard Deviation 12.5765 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 16 | 0.579 U/L | Standard Deviation 12.9273 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 4 | 0.854 U/L | Standard Deviation 26.6238 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 8 | 0.795 U/L | Standard Deviation 11.4321 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 8 | 3.513 U/L | Standard Deviation 18.6503 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 28 | -8.314 U/L | Standard Deviation 10.9054 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 12 | 3.342 U/L | Standard Deviation 17.0346 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 24 | -6.361 U/L | Standard Deviation 12.7843 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 20 | -7.027 U/L | Standard Deviation 11.8544 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 16 | 0.474 U/L | Standard Deviation 19.8967 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 16 | -4.605 U/L | Standard Deviation 11.6539 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 12 | -4.947 U/L | Standard Deviation 12.0538 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 28 | -0.171 U/L | Standard Deviation 8.7228 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 24 | 1.944 U/L | Standard Deviation 23.5638 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 8 | -5.026 U/L | Standard Deviation 10.2019 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 28 | 8.143 U/L | Standard Deviation 44.0929 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 4 | -1.439 U/L | Standard Deviation 18.3508 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 12 | 1.184 U/L | Standard Deviation 13.0692 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 32 | -2.971 U/L | Standard Deviation 27.9171 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 1 | -3.244 U/L | Standard Deviation 4.9989 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 32 | 0.324 U/L | Standard Deviation 6.2654 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 28 | 2.229 U/L | Standard Deviation 6.3063 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 40 | -10.618 U/L | Standard Deviation 24.4293 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 36 | 1.588 U/L | Standard Deviation 6.6017 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 24 | 2.889 U/L | Standard Deviation 6.2554 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 20 | 1.324 U/L | Standard Deviation 7.1065 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 48 | -3.794 U/L | Standard Deviation 13.1628 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 44 | -0.588 U/L | Standard Deviation 7.719 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 16 | 1.526 U/L | Standard Deviation 6.6688 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 48 | 0.441 U/L | Standard Deviation 6.6796 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 12 | 1.053 U/L | Standard Deviation 6.9006 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 24 | 1.528 U/L | Standard Deviation 11.0259 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 1 | 0.171 U/L | Standard Deviation 5.0245 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 44 | -5.059 U/L | Standard Deviation 22.2683 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 2 | -0.341 U/L | Standard Deviation 5.2517 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 8 | 1.410 U/L | Standard Deviation 5.59 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 4 | 1.171 U/L | Standard Deviation 17.6265 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 12 | 1.122 U/L | Standard Deviation 6.2897 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 8 | 1.439 U/L | Standard Deviation 24.023 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 40 | -1.385 U/L | Standard Deviation 13.1061 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 32 | 2.051 U/L | Standard Deviation 4.9997 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 8 | -1.805 U/L | Standard Deviation 9.0698 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 1 | 0.700 U/L | Standard Deviation 9.5868 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 24 | -7.225 U/L | Standard Deviation 18.4231 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 8 | -1.659 U/L | Standard Deviation 11.1009 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 44 | -2.692 U/L | Standard Deviation 10.2525 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 12 | 3.244 U/L | Standard Deviation 21.8229 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 12 | 1.049 U/L | Standard Deviation 22.9303 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 2 | 0.780 U/L | Standard Deviation 6.1746 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 2 | 1.171 U/L | Standard Deviation 10.2978 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 24 | 0.325 U/L | Standard Deviation 4.3759 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 16 | 15.024 U/L | Standard Deviation 77.1617 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 36 | 5.436 U/L | Standard Deviation 30.0436 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 4 | -1.195 U/L | Standard Deviation 4.2791 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 36 | -1.103 U/L | Standard Deviation 10.6296 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 28 | -2.775 U/L | Standard Deviation 10.428 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 20 | 1.475 U/L | Standard Deviation 22.2722 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 48 | 2.900 U/L | Standard Deviation 6.2339 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 40 | 2.462 U/L | Standard Deviation 8.4972 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 16 | 1.488 U/L | Standard Deviation 21.8325 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 16 | -1.512 U/L | Standard Deviation 25.7722 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 24 | -2.625 U/L | Standard Deviation 10.3272 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 36 | 1.667 U/L | Standard Deviation 6.0755 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 20 | 2.025 U/L | Standard Deviation 23.0401 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 20 | -1.350 U/L | Standard Deviation 10.5479 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 12 | -3.146 U/L | Standard Deviation 17.2476 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 28 | -0.200 U/L | Standard Deviation 11.5585 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 48 | -7.875 U/L | Standard Deviation 20.137 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 44 | 1.675 U/L | Standard Deviation 24.9588 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 32 | 2.795 U/L | Standard Deviation 21.1501 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 40 | -8.175 U/L | Standard Deviation 17.8884 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 20 | 0.500 U/L | Standard Deviation 4.8569 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 40 | 0.000 U/L | Standard Deviation 29.3852 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 24 | 8.550 U/L | Standard Deviation 25.3093 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 36 | 1.410 U/L | Standard Deviation 18.02 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 20 | -6.650 U/L | Standard Deviation 14.8143 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 8 | -3.585 U/L | Standard Deviation 9.8336 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 48 | 4.500 U/L | Standard Deviation 37.812 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 8 | 0.366 U/L | Standard Deviation 6.1877 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 40 | 0.925 U/L | Standard Deviation 20.1066 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 16 | 0.829 U/L | Standard Deviation 11.5432 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 1 | 0.475 U/L | Standard Deviation 5.2963 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 16 | 2.122 U/L | Standard Deviation 6.1733 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 28 | 1.250 U/L | Standard Deviation 22.0962 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 44 | -0.949 U/L | Standard Deviation 11.5643 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 4 | -4.829 U/L | Standard Deviation 10.9268 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 2 | -1.268 U/L | Standard Deviation 7.8773 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 4 | -1.561 U/L | Standard Deviation 10.1392 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 4 | 0.512 U/L | Standard Deviation 16.3968 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 48 | 2.525 U/L | Standard Deviation 20.6112 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 44 | -8.950 U/L | Standard Deviation 18.3162 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 44 | 1.590 U/L | Standard Deviation 6.9347 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 32 | -0.821 U/L | Standard Deviation 11.5482 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 32 | -1.615 U/L | Standard Deviation 24.8052 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 1 | -1.075 U/L | Standard Deviation 18.4341 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 36 | -6.487 U/L | Standard Deviation 19.2434 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 2 | -3.585 U/L | Standard Deviation 8.843 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 1 | -4.275 U/L | Standard Deviation 7.136 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 12 | -1.390 U/L | Standard Deviation 8.1941 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 2 | 0.537 U/L | Standard Deviation 19.727 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 32 | -8.385 U/L | Standard Deviation 17.5988 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Gamma Glutamyl Transferase Week 1 | -2.300 U/L | Standard Deviation 6.2684 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 48 | -0.575 U/L | Standard Deviation 9.6181 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Aspartate Aminotransferase Week 28 | 0.175 U/L | Standard Deviation 4.1255 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Lactate Dehydrogenase Week 4 | -4.293 U/L | Standard Deviation 17.4732 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alkaline Phosphatase Week 28 | -8.525 U/L | Standard Deviation 16.8523 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine Aminotransferase Week 24 | -3.475 U/L | Standard Deviation 8.6202 |
Secondary
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Albumin was measured in grams per liter (g/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 4 | -0.683 g/L | Standard Deviation 2.4743 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 36 | -0.289 g/L | Standard Deviation 2.6397 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 12 | 0.073 g/L | Standard Deviation 2.402 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 1 | -1.000 g/L | Standard Deviation 1.7464 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 8 | -0.634 g/L | Standard Deviation 2.0094 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 2 | -0.500 g/L | Standard Deviation 2.0982 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 28 | -0.462 g/L | Standard Deviation 2.0881 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 48 | 0.132 g/L | Standard Deviation 2.28 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 44 | -0.297 g/L | Standard Deviation 2.012 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 32 | -0.179 g/L | Standard Deviation 1.7452 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 24 | 0.385 g/L | Standard Deviation 1.7262 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 20 | 0.175 g/L | Standard Deviation 1.9333 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 16 | 0.833 g/L | Standard Deviation 1.8468 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 40 | -0.108 g/L | Standard Deviation 2.0109 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 36 | 0.816 g/L | Standard Deviation 1.722 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 40 | 0.763 g/L | Standard Deviation 1.965 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 44 | 0.132 g/L | Standard Deviation 2.3269 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 48 | 0.632 g/L | Standard Deviation 2.9903 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 4 | 0.538 g/L | Standard Deviation 2.1007 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 8 | 0.154 g/L | Standard Deviation 2.1829 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 12 | 0.538 g/L | Standard Deviation 2.1986 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 1 | -0.079 g/L | Standard Deviation 2.1357 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 16 | 1.132 g/L | Standard Deviation 2.28 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 20 | 0.487 g/L | Standard Deviation 2.4047 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 24 | 0.949 g/L | Standard Deviation 2.3164 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 28 | 0.632 g/L | Standard Deviation 2.1362 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 32 | 0.359 g/L | Standard Deviation 1.8706 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 2 | 0.051 g/L | Standard Deviation 1.5719 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 20 | 0.976 g/L | Standard Deviation 1.7873 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 1 | 0.279 g/L | Standard Deviation 1.8038 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 16 | 0.881 g/L | Standard Deviation 2.0025 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 36 | 0.659 g/L | Standard Deviation 1.6064 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 28 | 0.976 g/L | Standard Deviation 1.9169 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 48 | 0.366 g/L | Standard Deviation 3.1682 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 44 | 0.659 g/L | Standard Deviation 2.2429 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 8 | 0.581 g/L | Standard Deviation 2.0843 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 32 | 0.700 g/L | Standard Deviation 1.9897 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 24 | 1.341 g/L | Standard Deviation 1.879 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 4 | 0.595 g/L | Standard Deviation 1.9514 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 40 | 0.805 g/L | Standard Deviation 1.8196 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 12 | 0.857 g/L | Standard Deviation 1.8685 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 2 | 0.419 g/L | Standard Deviation 1.9908 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 12 | 0.211 g/L | Standard Deviation 1.9474 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 48 | 0.088 g/L | Standard Deviation 2.6671 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 36 | -0.029 g/L | Standard Deviation 2.0815 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 16 | 0.316 g/L | Standard Deviation 2.0678 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 44 | -0.206 g/L | Standard Deviation 1.9661 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 20 | -0.081 g/L | Standard Deviation 2.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 1 | -0.439 g/L | Standard Deviation 1.8715 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 32 | -0.235 g/L | Standard Deviation 1.6341 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 24 | 0.722 g/L | Standard Deviation 2.2502 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 2 | -0.537 g/L | Standard Deviation 2.0988 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 40 | 0.000 g/L | Standard Deviation 1.8749 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 28 | 0.114 g/L | Standard Deviation 1.9819 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 8 | 0.077 g/L | Standard Deviation 2.2051 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 4 | -0.171 g/L | Standard Deviation 1.9862 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 48 | 0.150 g/L | Standard Deviation 2.3044 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 1 | -0.350 g/L | Standard Deviation 1.6259 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 2 | -0.073 g/L | Standard Deviation 1.822 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 4 | 0.220 g/L | Standard Deviation 1.9687 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 8 | 0.195 g/L | Standard Deviation 1.7638 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 12 | 0.415 g/L | Standard Deviation 2.121 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 16 | 0.683 g/L | Standard Deviation 1.9422 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 20 | 0.575 g/L | Standard Deviation 1.8659 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 24 | 0.875 g/L | Standard Deviation 2.3004 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 28 | 0.525 g/L | Standard Deviation 2.0999 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 32 | 0.667 g/L | Standard Deviation 1.9912 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 36 | 0.436 g/L | Standard Deviation 1.9166 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 40 | 0.400 g/L | Standard Deviation 1.9716 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Week 44 | 0.175 g/L | Standard Deviation 2.2858 |
Secondary
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 2 | -0.762 μmol/L | Standard Deviation 2.9415 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 8 | 1.366 μmol/L | Standard Deviation 8.3269 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 4 | 0.854 μmol/L | Standard Deviation 10.2508 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 2 | 2.310 μmol/L | Standard Deviation 11.13 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 32 | 0.233 μmol/L | Standard Deviation 3.2668 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 40 | 0.600 μmol/L | Standard Deviation 3.8064 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 1 | -0.512 μmol/L | Standard Deviation 6.6788 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 48 | 0.716 μmol/L | Standard Deviation 4.037 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 44 | -0.019 μmol/L | Standard Deviation 3.68 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 36 | 0.942 μmol/L | Standard Deviation 3.687 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 36 | 0.211 μmol/L | Standard Deviation 37.563 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 32 | 17.026 μmol/L | Standard Deviation 47.8185 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 28 | -0.897 μmol/L | Standard Deviation 29.4331 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 4 | -0.290 μmol/L | Standard Deviation 3.49 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 1 | -0.841 μmol/L | Standard Deviation 2.8968 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 24 | 17.410 μmol/L | Standard Deviation 45.0045 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 20 | 28.950 μmol/L | Standard Deviation 53.8602 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 16 | 25.810 μmol/L | Standard Deviation 44.1965 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 8 | -0.776 μmol/L | Standard Deviation 3.7242 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 16 | 0.607 μmol/L | Standard Deviation 3.7361 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 12 | 10.707 μmol/L | Standard Deviation 40.2208 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 8 | 5.415 μmol/L | Standard Deviation 42.95 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 4 | 10.171 μmol/L | Standard Deviation 41.5493 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 12 | -0.261 μmol/L | Standard Deviation 2.6113 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 48 | 8.684 μmol/L | Standard Deviation 53.6208 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 2 | 12.405 μmol/L | Standard Deviation 47.5795 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 1 | -1.220 μmol/L | Standard Deviation 37.4503 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 48 | 3.000 μmol/L | Standard Deviation 10.3299 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 44 | 4.543 μmol/L | Standard Deviation 10.667 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 40 | 3.838 μmol/L | Standard Deviation 9.5205 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 36 | 0.289 μmol/L | Standard Deviation 7.5656 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 20 | -0.007 μmol/L | Standard Deviation 3.3543 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 44 | 20.541 μmol/L | Standard Deviation 57.9164 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 32 | 1.718 μmol/L | Standard Deviation 8.8227 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 28 | 2.921 μmol/L | Standard Deviation 7.0227 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 24 | 1.359 μmol/L | Standard Deviation 8.1741 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 24 | 0.146 μmol/L | Standard Deviation 3.2508 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 40 | 9.730 μmol/L | Standard Deviation 43.5295 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 20 | 3.150 μmol/L | Standard Deviation 8.3468 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 16 | 1.833 μmol/L | Standard Deviation 8.4678 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 12 | 1.268 μmol/L | Standard Deviation 8.0282 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 28 | -0.200 μmol/L | Standard Deviation 3.6974 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 16 | 0.637 μmol/L | Standard Deviation 3.7786 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 1 | -1.195 μmol/L | Standard Deviation 3.1083 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 2 | 0.492 μmol/L | Standard Deviation 3.1202 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 4 | 0.789 μmol/L | Standard Deviation 2.8952 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 8 | 0.541 μmol/L | Standard Deviation 3.1822 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 12 | 0.341 μmol/L | Standard Deviation 3.005 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 20 | 0.136 μmol/L | Standard Deviation 3.4239 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 24 | 0.592 μmol/L | Standard Deviation 4.4981 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 28 | -0.068 μmol/L | Standard Deviation 3.8885 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 32 | 0.262 μmol/L | Standard Deviation 3.7358 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 36 | 0.776 μmol/L | Standard Deviation 4.3703 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 40 | 0.679 μmol/L | Standard Deviation 3.4707 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 44 | -0.276 μmol/L | Standard Deviation 3.1827 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 48 | 0.559 μmol/L | Standard Deviation 3.246 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 1 | 0.368 μmol/L | Standard Deviation 7.3757 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 2 | 0.026 μmol/L | Standard Deviation 6.1194 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 4 | 1.256 μmol/L | Standard Deviation 7.0812 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 8 | 1.487 μmol/L | Standard Deviation 8.3756 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 12 | 0.949 μmol/L | Standard Deviation 8.6113 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 16 | 1.421 μmol/L | Standard Deviation 10.7945 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 20 | 1.051 μmol/L | Standard Deviation 7.7966 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 24 | 0.103 μmol/L | Standard Deviation 6.8817 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 28 | 1.737 μmol/L | Standard Deviation 7.4858 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 32 | 2.462 μmol/L | Standard Deviation 9.136 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 36 | 1.632 μmol/L | Standard Deviation 7.16 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 40 | 2.974 μmol/L | Standard Deviation 7.3796 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 44 | 4.250 μmol/L | Standard Deviation 8.7876 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 48 | 4.667 μmol/L | Standard Deviation 8.5355 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 1 | -0.237 μmol/L | Standard Deviation 43.01 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 2 | -2.974 μmol/L | Standard Deviation 44.8826 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 4 | 0.308 μmol/L | Standard Deviation 47.3193 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 8 | -6.231 μmol/L | Standard Deviation 40.4198 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 12 | 6.795 μmol/L | Standard Deviation 54.4814 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 16 | 8.079 μmol/L | Standard Deviation 50.0062 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 20 | 4.692 μmol/L | Standard Deviation 59.042 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 24 | 9.923 μmol/L | Standard Deviation 54.9648 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 28 | 9.447 μmol/L | Standard Deviation 59.8655 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 32 | 2.821 μmol/L | Standard Deviation 48.9042 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 36 | -4.868 μmol/L | Standard Deviation 49.1419 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 40 | 15.605 μmol/L | Standard Deviation 53.8931 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 44 | 7.605 μmol/L | Standard Deviation 64.3342 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 48 | 3.895 μmol/L | Standard Deviation 48.5831 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 4 | 1.762 μmol/L | Standard Deviation 8.8229 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 40 | 4.122 μmol/L | Standard Deviation 9.7575 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 28 | 18.976 μmol/L | Standard Deviation 62.4894 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 16 | 15.357 μmol/L | Standard Deviation 59.0311 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 16 | 0.740 μmol/L | Standard Deviation 3.2505 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 12 | 13.881 μmol/L | Standard Deviation 55.3332 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 44 | 3.659 μmol/L | Standard Deviation 8.5311 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 24 | 0.383 μmol/L | Standard Deviation 3.1235 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 8 | 0.442 μmol/L | Standard Deviation 3.8005 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 8 | 11.791 μmol/L | Standard Deviation 64.991 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 4 | 13.452 μmol/L | Standard Deviation 49.1633 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 48 | 3.923 μmol/L | Standard Deviation 7.7371 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 2 | 2.093 μmol/L | Standard Deviation 8.4426 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 2 | 9.791 μmol/L | Standard Deviation 61.4009 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 20 | 4.976 μmol/L | Standard Deviation 10.5818 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 48 | -3.220 μmol/L | Standard Deviation 64.9282 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 1 | 11.953 μmol/L | Standard Deviation 60.5652 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 1 | -0.465 μmol/L | Standard Deviation 3.4868 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 40 | 9.976 μmol/L | Standard Deviation 62.8739 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 12 | 0.095 μmol/L | Standard Deviation 2.5793 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 32 | 0.655 μmol/L | Standard Deviation 3.1125 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 48 | 0.285 μmol/L | Standard Deviation 3.8393 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 44 | -0.102 μmol/L | Standard Deviation 3.1253 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 24 | 3.829 μmol/L | Standard Deviation 11.4256 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 12 | 6.214 μmol/L | Standard Deviation 9.5062 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 40 | 0.415 μmol/L | Standard Deviation 3.3481 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 8 | 3.674 μmol/L | Standard Deviation 10.1997 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 2 | 0.516 μmol/L | Standard Deviation 2.703 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 28 | 4.634 μmol/L | Standard Deviation 8.9576 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 1 | 2.442 μmol/L | Standard Deviation 7.8628 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 36 | 0.078 μmol/L | Standard Deviation 3.8443 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 20 | 1.062 μmol/L | Standard Deviation 3.8164 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 24 | 3.683 μmol/L | Standard Deviation 58.6977 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 32 | 2.500 μmol/L | Standard Deviation 8.9299 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 28 | 0.105 μmol/L | Standard Deviation 2.555 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 4 | -0.119 μmol/L | Standard Deviation 3.2318 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 20 | 16.048 μmol/L | Standard Deviation 63.4346 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 36 | -10.927 μmol/L | Standard Deviation 59.4228 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 36 | 1.024 μmol/L | Standard Deviation 8.8218 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 32 | 5.800 μmol/L | Standard Deviation 56.2017 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 44 | -8.854 μmol/L | Standard Deviation 67.3523 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 16 | 3.738 μmol/L | Standard Deviation 7.7964 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 4 | -0.561 μmol/L | Standard Deviation 7.3418 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 2 | 0.978 μmol/L | Standard Deviation 2.9538 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 8 | 1.590 μmol/L | Standard Deviation 7.9131 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 12 | 1.947 μmol/L | Standard Deviation 9.1236 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 24 | 1.081 μmol/L | Standard Deviation 2.8708 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 16 | 0.658 μmol/L | Standard Deviation 8.7897 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 32 | 3.971 μmol/L | Standard Deviation 45.1103 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 20 | 2.270 μmol/L | Standard Deviation 8.5461 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 24 | 1.972 μmol/L | Standard Deviation 9.3914 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 20 | 1.030 μmol/L | Standard Deviation 3.8636 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 28 | 1.371 μmol/L | Standard Deviation 8.3634 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 32 | 4.118 μmol/L | Standard Deviation 12.0825 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 36 | 1.853 μmol/L | Standard Deviation 10.8492 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 16 | 1.092 μmol/L | Standard Deviation 3.7662 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 36 | 4.735 μmol/L | Standard Deviation 42.4309 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 40 | 0.647 μmol/L | Standard Deviation 10.7672 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 44 | 3.364 μmol/L | Standard Deviation 10.6853 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 48 | 2.879 μmol/L | Standard Deviation 9.8513 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 12 | 0.629 μmol/L | Standard Deviation 3.2367 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 1 | 8.732 μmol/L | Standard Deviation 39.4088 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 2 | 9.073 μmol/L | Standard Deviation 39.343 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 40 | -5.029 μmol/L | Standard Deviation 41.263 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 4 | 5.659 μmol/L | Standard Deviation 31.2591 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 8 | 0.972 μmol/L | Standard Deviation 3.4557 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 8 | 3.410 μmol/L | Standard Deviation 33.9518 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 1 | 0.471 μmol/L | Standard Deviation 3.0332 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 12 | 7.553 μmol/L | Standard Deviation 33.4904 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 48 | 1.853 μmol/L | Standard Deviation 54.8762 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 16 | 14.026 μmol/L | Standard Deviation 40.5173 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 4 | 1.066 μmol/L | Standard Deviation 3.4454 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 20 | 10.622 μmol/L | Standard Deviation 42.1567 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 44 | 1.382 μmol/L | Standard Deviation 47.9558 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 24 | 6.667 μmol/L | Standard Deviation 45.258 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 36 | 1.012 μmol/L | Standard Deviation 3.5311 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 40 | 1.065 μmol/L | Standard Deviation 3.1718 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 44 | 0.871 μmol/L | Standard Deviation 2.8347 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 32 | 0.994 μmol/L | Standard Deviation 2.6879 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 48 | 1.124 μmol/L | Standard Deviation 3.2882 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 1 | 1.366 μmol/L | Standard Deviation 8.9044 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 28 | -6.371 μmol/L | Standard Deviation 40.1227 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 2 | 2.537 μmol/L | Standard Deviation 6.8304 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 28 | 0.449 μmol/L | Standard Deviation 3.4106 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 20 | 4.525 μmol/L | Standard Deviation 7.4144 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 16 | 21.683 μmol/L | Standard Deviation 41.167 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 16 | 3.976 μmol/L | Standard Deviation 8.2719 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 36 | 3.462 μmol/L | Standard Deviation 6.8127 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 16 | 2.024 μmol/L | Standard Deviation 3.7217 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 12 | 2.220 μmol/L | Standard Deviation 8.2417 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 20 | 10.600 μmol/L | Standard Deviation 44.3262 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 32 | 4.974 μmol/L | Standard Deviation 7.7408 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 4 | 2.171 μmol/L | Standard Deviation 6.9279 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 48 | 8.050 μmol/L | Standard Deviation 49.1956 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 1 | 1.300 μmol/L | Standard Deviation 6.73 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 28 | 4.900 μmol/L | Standard Deviation 7.2388 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 28 | 1.595 μmol/L | Standard Deviation 3.4093 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 36 | 1.095 μmol/L | Standard Deviation 2.3971 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 24 | 6.950 μmol/L | Standard Deviation 45.8638 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 24 | 4.650 μmol/L | Standard Deviation 7.2627 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 28 | 1.250 μmol/L | Standard Deviation 45.8972 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 40 | 1.433 μmol/L | Standard Deviation 3.3425 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 32 | 1.669 μmol/L | Standard Deviation 4.0868 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 2 | 1.395 μmol/L | Standard Deviation 4.0672 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 1 | 11.650 μmol/L | Standard Deviation 61.0924 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 48 | 3.256 μmol/L | Standard Deviation 7.029 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 32 | 17.077 μmol/L | Standard Deviation 40.3089 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 2 | 15.610 μmol/L | Standard Deviation 49.0693 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 8 | 0.639 μmol/L | Standard Deviation 2.8243 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 24 | 1.128 μmol/L | Standard Deviation 2.8112 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 1 | 0.385 μmol/L | Standard Deviation 2.2726 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 44 | 1.851 μmol/L | Standard Deviation 3.7976 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 4 | -4.293 μmol/L | Standard Deviation 47.5753 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 8 | 3.073 μmol/L | Standard Deviation 5.781 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 40 | 7.255 μmol/L | Standard Deviation 46.0833 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 12 | 2.073 μmol/L | Standard Deviation 4.0034 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 44 | 10.675 μmol/L | Standard Deviation 50.8963 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 8 | 8.024 μmol/L | Standard Deviation 44.0043 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 44 | 3.925 μmol/L | Standard Deviation 8.0012 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 20 | 1.225 μmol/L | Standard Deviation 2.9632 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 36 | 5.846 μmol/L | Standard Deviation 49.4259 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 2 | 3.317 μmol/L | Standard Deviation 6.747 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Urate Week 12 | 2.805 μmol/L | Standard Deviation 37.6651 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 4 | 1.344 μmol/L | Standard Deviation 3.7625 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin Week 48 | 1.160 μmol/L | Standard Deviation 3.9493 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Creatinine Week 40 | 3.200 μmol/L | Standard Deviation 7.0208 |
Secondary
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 20 | -0.007 mmol/L | Standard Deviation 0.0811 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 32 | -0.085 mmol/L | Standard Deviation 0.854 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 8 | -0.854 mmol/L | Standard Deviation 2.007 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 16 | -0.002 mmol/L | Standard Deviation 0.0742 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 12 | 0.010 mmol/L | Standard Deviation 0.0797 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 8 | -0.016 mmol/L | Standard Deviation 0.0706 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 36 | 0.005 mmol/L | Standard Deviation 0.7322 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 4 | -0.022 mmol/L | Standard Deviation 0.0606 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 2 | -0.004 mmol/L | Standard Deviation 0.0795 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 40 | -0.103 mmol/L | Standard Deviation 0.7541 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 1 | -0.010 mmol/L | Standard Deviation 0.0672 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 44 | -0.170 mmol/L | Standard Deviation 0.8082 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 4 | -0.293 mmol/L | Standard Deviation 1.9525 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 44 | 0.222 mmol/L | Standard Deviation 1.4919 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 20 | 0.208 mmol/L | Standard Deviation 1.056 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 16 | 0.176 mmol/L | Standard Deviation 0.8363 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 48 | -0.282 mmol/L | Standard Deviation 0.7891 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 48 | -0.237 mmol/L | Standard Deviation 1.7772 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 12 | 0.110 mmol/L | Standard Deviation 0.9146 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 8 | 0.112 mmol/L | Standard Deviation 0.9127 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 4 | 0.298 mmol/L | Standard Deviation 0.8575 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 1 | 0.307 mmol/L | Standard Deviation 1.3942 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 4 | -0.732 mmol/L | Standard Deviation 1.8442 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 2 | 0.062 mmol/L | Standard Deviation 0.6681 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 2 | -0.500 mmol/L | Standard Deviation 1.6417 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 48 | -0.137 mmol/L | Standard Deviation 0.3627 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 8 | -0.537 mmol/L | Standard Deviation 2.192 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 44 | -0.486 mmol/L | Standard Deviation 1.8352 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 44 | -0.119 mmol/L | Standard Deviation 0.2933 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 40 | -0.092 mmol/L | Standard Deviation 0.3616 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 36 | -0.092 mmol/L | Standard Deviation 0.3388 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 12 | 0.341 mmol/L | Standard Deviation 2.2205 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 44 | -0.027 mmol/L | Standard Deviation 0.092 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 32 | -0.062 mmol/L | Standard Deviation 0.3306 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 28 | -0.077 mmol/L | Standard Deviation 0.3141 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 24 | -0.095 mmol/L | Standard Deviation 0.3308 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 20 | -0.325 mmol/L | Standard Deviation 2.464 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 4 | -0.029 mmol/L | Standard Deviation 0.1079 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 20 | -0.092 mmol/L | Standard Deviation 0.3846 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 16 | -0.086 mmol/L | Standard Deviation 0.3258 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 12 | -0.073 mmol/L | Standard Deviation 0.3217 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 24 | -0.615 mmol/L | Standard Deviation 2.0081 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 8 | -0.056 mmol/L | Standard Deviation 0.2907 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 4 | -0.080 mmol/L | Standard Deviation 0.2522 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 28 | 0.128 mmol/L | Standard Deviation 2.319 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 40 | -0.032 mmol/L | Standard Deviation 0.0681 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 36 | -0.015 mmol/L | Standard Deviation 0.0694 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 32 | -0.154 mmol/L | Standard Deviation 2.2069 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 40 | -0.432 mmol/L | Standard Deviation 2.1153 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 32 | -0.023 mmol/L | Standard Deviation 0.0727 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 24 | -0.005 mmol/L | Standard Deviation 0.0757 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 48 | -0.013 mmol/L | Standard Deviation 1.2512 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 36 | 0.237 mmol/L | Standard Deviation 1.9923 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 36 | -0.711 mmol/L | Standard Deviation 2.0122 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 40 | 0.143 mmol/L | Standard Deviation 1.0885 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 36 | 0.089 mmol/L | Standard Deviation 0.9061 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 32 | 0.333 mmol/L | Standard Deviation 1.2671 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 28 | 0.246 mmol/L | Standard Deviation 1.1812 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 32 | -1.077 mmol/L | Standard Deviation 1.8692 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 24 | 0.018 mmol/L | Standard Deviation 1.1856 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 28 | -0.044 mmol/L | Standard Deviation 0.9797 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 12 | -0.124 mmol/L | Standard Deviation 0.6719 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 48 | 0.605 mmol/L | Standard Deviation 2.0994 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 48 | -0.010 mmol/L | Standard Deviation 0.0881 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 44 | 0.135 mmol/L | Standard Deviation 1.9027 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 40 | -0.054 mmol/L | Standard Deviation 2.538 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 16 | -0.310 mmol/L | Standard Deviation 1.8934 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 1 | -0.254 mmol/L | Standard Deviation 0.4371 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 2 | -0.021 mmol/L | Standard Deviation 0.0951 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 2 | -0.224 mmol/L | Standard Deviation 0.4154 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 28 | -0.462 mmol/L | Standard Deviation 2.2924 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 2 | -0.214 mmol/L | Standard Deviation 2.1131 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 40 | 0.003 mmol/L | Standard Deviation 0.0905 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 24 | 0.011 mmol/L | Standard Deviation 0.1019 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 4 | -0.198 mmol/L | Standard Deviation 0.6334 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 24 | -0.821 mmol/L | Standard Deviation 1.7751 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 16 | 0.004 mmol/L | Standard Deviation 0.0826 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 12 | -0.021 mmol/L | Standard Deviation 0.1009 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 8 | -0.190 mmol/L | Standard Deviation 0.6935 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 20 | -0.675 mmol/L | Standard Deviation 1.7155 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 8 | -0.024 mmol/L | Standard Deviation 0.0942 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 36 | -0.013 mmol/L | Standard Deviation 0.1172 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 1 | -0.195 mmol/L | Standard Deviation 2.1121 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 32 | -0.023 mmol/L | Standard Deviation 0.1069 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 28 | -0.027 mmol/L | Standard Deviation 0.1117 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 20 | 0.002 mmol/L | Standard Deviation 0.0931 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 16 | 0.095 mmol/L | Standard Deviation 0.6811 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 1 | -0.034 mmol/L | Standard Deviation 0.081 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 1 | -0.146 mmol/L | Standard Deviation 1.5582 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 2 | -0.098 mmol/L | Standard Deviation 0.2975 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 1 | -0.095 mmol/L | Standard Deviation 0.2701 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 20 | 0.053 mmol/L | Standard Deviation 0.7609 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 16 | -0.738 mmol/L | Standard Deviation 1.8086 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 48 | -0.004 mmol/L | Standard Deviation 0.0633 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 24 | 0.041 mmol/L | Standard Deviation 0.8729 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 12 | -0.512 mmol/L | Standard Deviation 1.8858 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 44 | -0.024 mmol/L | Standard Deviation 0.0677 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 28 | -0.027 mmol/L | Standard Deviation 0.0713 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 4 | -0.011 mmol/L | Standard Deviation 0.1015 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 44 | -0.018 mmol/L | Standard Deviation 0.0861 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 48 | -0.009 mmol/L | Standard Deviation 0.1033 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 2 | 0.308 mmol/L | Standard Deviation 2.6273 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 4 | -0.333 mmol/L | Standard Deviation 2.275 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 8 | 0.615 mmol/L | Standard Deviation 2.4346 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 12 | -0.282 mmol/L | Standard Deviation 2.3946 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 20 | -0.538 mmol/L | Standard Deviation 2.1502 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 32 | 0.436 mmol/L | Standard Deviation 2.3708 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 36 | 0.684 mmol/L | Standard Deviation 2.4285 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 44 | 0.579 mmol/L | Standard Deviation 2.6977 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 48 | 0.737 mmol/L | Standard Deviation 2.8158 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 1 | 0.032 mmol/L | Standard Deviation 0.4307 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 2 | 0.108 mmol/L | Standard Deviation 0.5132 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 4 | -0.023 mmol/L | Standard Deviation 0.5905 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 8 | -0.023 mmol/L | Standard Deviation 0.577 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 12 | 0.013 mmol/L | Standard Deviation 0.7473 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 16 | 0.184 mmol/L | Standard Deviation 0.6378 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 20 | 0.126 mmol/L | Standard Deviation 0.6889 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 28 | -0.037 mmol/L | Standard Deviation 0.893 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 32 | -0.079 mmol/L | Standard Deviation 0.8918 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 44 | -0.176 mmol/L | Standard Deviation 1.0874 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 48 | -0.279 mmol/L | Standard Deviation 0.8348 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 1 | 0.103 mmol/L | Standard Deviation 0.7027 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 4 | 0.015 mmol/L | Standard Deviation 0.6888 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 8 | 0.308 mmol/L | Standard Deviation 0.7696 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 12 | 0.005 mmol/L | Standard Deviation 0.6117 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 16 | 0.195 mmol/L | Standard Deviation 0.6316 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 36 | 0.342 mmol/L | Standard Deviation 0.9406 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 44 | 0.200 mmol/L | Standard Deviation 1.095 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 1 | -0.007 mmol/L | Standard Deviation 0.0676 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 4 | 0.009 mmol/L | Standard Deviation 0.0725 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 8 | -0.008 mmol/L | Standard Deviation 0.0593 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 12 | 0.008 mmol/L | Standard Deviation 0.0847 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 16 | 0.003 mmol/L | Standard Deviation 0.0823 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 20 | -0.012 mmol/L | Standard Deviation 0.0728 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 44 | -0.000 mmol/L | Standard Deviation 0.0597 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 48 | -0.004 mmol/L | Standard Deviation 0.0546 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 1 | -0.184 mmol/L | Standard Deviation 1.7531 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 8 | -0.006 mmol/L | Standard Deviation 0.0926 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 20 | 0.000 mmol/L | Standard Deviation 0.1013 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 28 | 0.002 mmol/L | Standard Deviation 0.0877 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 32 | 0.000 mmol/L | Standard Deviation 0.0952 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 36 | 0.007 mmol/L | Standard Deviation 0.0804 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 12 | -0.025 mmol/L | Standard Deviation 0.109 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 16 | -0.006 mmol/L | Standard Deviation 0.1079 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 24 | -0.002 mmol/L | Standard Deviation 0.1028 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 40 | 0.001 mmol/L | Standard Deviation 0.0807 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 1 | -0.105 mmol/L | Standard Deviation 2.5446 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 16 | 0.026 mmol/L | Standard Deviation 2.2837 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 24 | -0.128 mmol/L | Standard Deviation 2.5462 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 28 | 0.000 mmol/L | Standard Deviation 2.6913 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 40 | 0.263 mmol/L | Standard Deviation 2.6271 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 24 | 0.013 mmol/L | Standard Deviation 0.8673 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 36 | 0.024 mmol/L | Standard Deviation 0.7951 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 40 | -0.118 mmol/L | Standard Deviation 0.9109 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 2 | 0.013 mmol/L | Standard Deviation 0.8348 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 20 | 0.315 mmol/L | Standard Deviation 1.0225 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 24 | 0.092 mmol/L | Standard Deviation 0.7747 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 28 | 0.263 mmol/L | Standard Deviation 0.9371 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 32 | 0.236 mmol/L | Standard Deviation 0.7013 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 40 | 0.245 mmol/L | Standard Deviation 1.1081 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 48 | 0.045 mmol/L | Standard Deviation 0.8472 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 2 | 0.008 mmol/L | Standard Deviation 0.0745 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 24 | -0.004 mmol/L | Standard Deviation 0.0572 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 28 | -0.007 mmol/L | Standard Deviation 0.0525 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 32 | -0.016 mmol/L | Standard Deviation 0.0641 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 36 | -0.001 mmol/L | Standard Deviation 0.0596 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 40 | -0.007 mmol/L | Standard Deviation 0.0541 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 1 | 0.089 mmol/L | Standard Deviation 0.3608 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 2 | 0.085 mmol/L | Standard Deviation 0.4095 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 4 | 0.008 mmol/L | Standard Deviation 0.3821 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 8 | 0.069 mmol/L | Standard Deviation 0.3221 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 12 | 0.033 mmol/L | Standard Deviation 0.3398 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 16 | 0.083 mmol/L | Standard Deviation 0.3112 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 20 | 0.031 mmol/L | Standard Deviation 0.3381 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 24 | -0.072 mmol/L | Standard Deviation 0.3052 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 28 | 0.105 mmol/L | Standard Deviation 0.3616 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 32 | 0.069 mmol/L | Standard Deviation 0.3621 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 36 | 0.045 mmol/L | Standard Deviation 0.3689 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 40 | 0.089 mmol/L | Standard Deviation 0.3826 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 44 | 0.029 mmol/L | Standard Deviation 0.3571 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 48 | -0.053 mmol/L | Standard Deviation 0.3244 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 2 | -0.513 mmol/L | Standard Deviation 1.8191 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 4 | -0.385 mmol/L | Standard Deviation 1.6482 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 8 | -0.410 mmol/L | Standard Deviation 1.3711 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 12 | -0.513 mmol/L | Standard Deviation 1.4845 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 16 | -0.211 mmol/L | Standard Deviation 1.7423 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 20 | -0.538 mmol/L | Standard Deviation 1.4482 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 24 | -0.487 mmol/L | Standard Deviation 1.5196 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 28 | -0.658 mmol/L | Standard Deviation 1.8494 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 32 | -0.128 mmol/L | Standard Deviation 1.9219 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 36 | -0.263 mmol/L | Standard Deviation 1.8986 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 40 | -0.474 mmol/L | Standard Deviation 1.6397 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 44 | -0.737 mmol/L | Standard Deviation 2.0492 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 48 | -0.763 mmol/L | Standard Deviation 1.8074 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 1 | -0.017 mmol/L | Standard Deviation 0.0984 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 2 | 0.002 mmol/L | Standard Deviation 0.0973 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 4 | 0.248 mmol/L | Standard Deviation 0.7693 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 28 | 0.009 mmol/L | Standard Deviation 0.1068 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 16 | 0.138 mmol/L | Standard Deviation 0.6814 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 36 | 0.066 mmol/L | Standard Deviation 0.4316 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 36 | -0.005 mmol/L | Standard Deviation 0.1096 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 20 | 0.267 mmol/L | Standard Deviation 1.0132 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 4 | 0.000 mmol/L | Standard Deviation 2.4792 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 32 | 0.023 mmol/L | Standard Deviation 0.4154 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 44 | 0.756 mmol/L | Standard Deviation 2.1069 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 48 | -0.014 mmol/L | Standard Deviation 0.1126 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 40 | 0.707 mmol/L | Standard Deviation 2.4418 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 1 | -0.008 mmol/L | Standard Deviation 0.0858 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 28 | 0.322 mmol/L | Standard Deviation 1.1372 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 12 | 0.117 mmol/L | Standard Deviation 0.7616 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 28 | 0.063 mmol/L | Standard Deviation 0.4265 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 28 | -0.683 mmol/L | Standard Deviation 1.8767 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 32 | 0.570 mmol/L | Standard Deviation 1.0301 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 36 | 0.732 mmol/L | Standard Deviation 1.9239 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 24 | 0.328 mmol/L | Standard Deviation 0.8554 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 40 | 0.507 mmol/L | Standard Deviation 1.1257 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 28 | -0.018 mmol/L | Standard Deviation 0.0678 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 24 | 0.030 mmol/L | Standard Deviation 0.3844 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 20 | 0.055 mmol/L | Standard Deviation 0.3494 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 48 | 0.141 mmol/L | Standard Deviation 0.9341 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 2 | 0.093 mmol/L | Standard Deviation 2.75 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 2 | 0.009 mmol/L | Standard Deviation 0.1304 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 40 | -0.512 mmol/L | Standard Deviation 2.1578 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 20 | 0.262 mmol/L | Standard Deviation 2.3484 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 2 | -0.011 mmol/L | Standard Deviation 0.0771 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 4 | -0.021 mmol/L | Standard Deviation 0.0973 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 16 | 0.012 mmol/L | Standard Deviation 0.3651 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 8 | 0.284 mmol/L | Standard Deviation 0.8012 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 12 | -0.024 mmol/L | Standard Deviation 0.3192 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 16 | -0.021 mmol/L | Standard Deviation 0.0659 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 8 | 0.008 mmol/L | Standard Deviation 0.126 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 20 | -0.018 mmol/L | Standard Deviation 0.0659 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 24 | -0.014 mmol/L | Standard Deviation 0.0732 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 16 | 0.424 mmol/L | Standard Deviation 1.1521 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 32 | -0.525 mmol/L | Standard Deviation 1.8809 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 32 | 0.500 mmol/L | Standard Deviation 2.2072 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 4 | 0.210 mmol/L | Standard Deviation 0.8027 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 32 | -0.016 mmol/L | Standard Deviation 0.0603 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 16 | -0.714 mmol/L | Standard Deviation 1.7708 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 44 | -0.008 mmol/L | Standard Deviation 0.1023 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 8 | 0.014 mmol/L | Standard Deviation 0.3306 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 36 | -0.031 mmol/L | Standard Deviation 0.0698 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 16 | 0.023 mmol/L | Standard Deviation 0.1334 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 4 | 0.026 mmol/L | Standard Deviation 0.2632 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 20 | 0.017 mmol/L | Standard Deviation 0.0999 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 8 | -0.013 mmol/L | Standard Deviation 0.0819 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 40 | -0.014 mmol/L | Standard Deviation 0.0754 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 2 | 0.002 mmol/L | Standard Deviation 0.3327 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 1 | 0.081 mmol/L | Standard Deviation 0.4289 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 12 | 0.188 mmol/L | Standard Deviation 0.7533 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 36 | -0.512 mmol/L | Standard Deviation 1.8725 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 8 | -0.860 mmol/L | Standard Deviation 2.2316 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 32 | 0.001 mmol/L | Standard Deviation 0.1074 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 48 | -0.014 mmol/L | Standard Deviation 0.0569 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 4 | -0.012 mmol/L | Standard Deviation 0.0789 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 48 | 0.012 mmol/L | Standard Deviation 0.8883 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 8 | 0.258 mmol/L | Standard Deviation 0.9254 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 1 | -0.674 mmol/L | Standard Deviation 4.1388 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 12 | 0.021 mmol/L | Standard Deviation 0.1057 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 2 | -0.209 mmol/L | Standard Deviation 1.9341 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 2 | 0.295 mmol/L | Standard Deviation 0.5178 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 12 | 0.548 mmol/L | Standard Deviation 2.5681 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 44 | -0.009 mmol/L | Standard Deviation 0.0685 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 2 | 0.221 mmol/L | Standard Deviation 0.9652 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 40 | -0.007 mmol/L | Standard Deviation 0.1084 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 16 | 0.190 mmol/L | Standard Deviation 2.0864 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 20 | -0.857 mmol/L | Standard Deviation 2.1928 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 24 | -0.390 mmol/L | Standard Deviation 2.6351 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 1 | 0.002 mmol/L | Standard Deviation 0.0694 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 28 | 0.195 mmol/L | Standard Deviation 2.3154 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 48 | -0.732 mmol/L | Standard Deviation 1.8845 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 1 | 0.077 mmol/L | Standard Deviation 1.1366 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 4 | -0.214 mmol/L | Standard Deviation 2.343 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 1 | 0.000 mmol/L | Standard Deviation 2.0471 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 48 | 1.024 mmol/L | Standard Deviation 2.4545 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 1 | 0.244 mmol/L | Standard Deviation 0.522 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 44 | 0.185 mmol/L | Standard Deviation 0.8688 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 48 | -0.032 mmol/L | Standard Deviation 0.3274 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 44 | 0.068 mmol/L | Standard Deviation 0.4344 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 8 | 0.047 mmol/L | Standard Deviation 2.6988 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 40 | 0.024 mmol/L | Standard Deviation 0.3484 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 20 | 0.186 mmol/L | Standard Deviation 0.9669 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 12 | -0.619 mmol/L | Standard Deviation 2.0357 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 44 | 0.071 mmol/L | Standard Deviation 0.9341 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 24 | 0.127 mmol/L | Standard Deviation 1.0682 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 24 | 0.015 mmol/L | Standard Deviation 0.0845 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 44 | -0.878 mmol/L | Standard Deviation 1.939 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 32 | 0.175 mmol/L | Standard Deviation 1.0895 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 36 | 0.234 mmol/L | Standard Deviation 1.0379 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 36 | 0.117 mmol/L | Standard Deviation 0.8408 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 24 | -0.463 mmol/L | Standard Deviation 2.0137 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 40 | 0.183 mmol/L | Standard Deviation 0.8947 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 12 | -0.011 mmol/L | Standard Deviation 0.0733 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 28 | 0.076 mmol/L | Standard Deviation 1.1434 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 40 | -0.024 mmol/L | Standard Deviation 0.0636 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 8 | -0.359 mmol/L | Standard Deviation 1.7394 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 44 | -0.024 mmol/L | Standard Deviation 0.0668 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 48 | -0.006 mmol/L | Standard Deviation 0.0616 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 16 | 0.068 mmol/L | Standard Deviation 0.6014 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 2 | 0.415 mmol/L | Standard Deviation 2.5296 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 4 | -0.047 mmol/L | Standard Deviation 0.1147 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 48 | -0.706 mmol/L | Standard Deviation 1.5281 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 8 | -0.004 mmol/L | Standard Deviation 0.1105 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 12 | -0.020 mmol/L | Standard Deviation 0.1088 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 16 | -0.004 mmol/L | Standard Deviation 0.1027 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 24 | 0.004 mmol/L | Standard Deviation 0.0896 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 12 | 0.005 mmol/L | Standard Deviation 0.6045 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 12 | -0.632 mmol/L | Standard Deviation 2.1738 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 28 | 0.008 mmol/L | Standard Deviation 0.0909 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 8 | 0.074 mmol/L | Standard Deviation 0.792 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 2 | -0.024 mmol/L | Standard Deviation 0.1001 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 4 | 0.093 mmol/L | Standard Deviation 0.6525 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 20 | -0.008 mmol/L | Standard Deviation 0.0948 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 16 | -0.842 mmol/L | Standard Deviation 2.3656 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 32 | -0.017 mmol/L | Standard Deviation 0.0932 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 2 | 0.054 mmol/L | Standard Deviation 0.5441 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 1 | -0.244 mmol/L | Standard Deviation 2.5572 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 12 | -0.211 mmol/L | Standard Deviation 2.3499 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 20 | -0.595 mmol/L | Standard Deviation 2.1661 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 48 | 0.971 mmol/L | Standard Deviation 2.5044 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 40 | 0.824 mmol/L | Standard Deviation 2.4676 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 1 | 0.105 mmol/L | Standard Deviation 0.469 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 20 | 0.116 mmol/L | Standard Deviation 0.7101 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 48 | -0.014 mmol/L | Standard Deviation 0.0912 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 24 | -0.003 mmol/L | Standard Deviation 0.6984 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 44 | 0.882 mmol/L | Standard Deviation 2.8044 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 36 | 0.001 mmol/L | Standard Deviation 0.0972 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 40 | -0.135 mmol/L | Standard Deviation 0.7454 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 24 | -0.472 mmol/L | Standard Deviation 1.8124 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 4 | 0.249 mmol/L | Standard Deviation 1.0659 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 12 | 0.111 mmol/L | Standard Deviation 0.6455 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 20 | 0.632 mmol/L | Standard Deviation 0.9741 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 28 | 0.263 mmol/L | Standard Deviation 1.0053 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 36 | 0.294 mmol/L | Standard Deviation 2.5999 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 28 | -0.457 mmol/L | Standard Deviation 2.3307 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 40 | 0.203 mmol/L | Standard Deviation 0.742 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 48 | 0.276 mmol/L | Standard Deviation 1.0841 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 1 | -0.014 mmol/L | Standard Deviation 0.0573 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 8 | -0.015 mmol/L | Standard Deviation 0.0706 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 12 | -0.001 mmol/L | Standard Deviation 0.066 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 16 | -0.009 mmol/L | Standard Deviation 0.0629 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 32 | 0.794 mmol/L | Standard Deviation 2.3196 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 1 | -0.002 mmol/L | Standard Deviation 0.099 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 32 | -0.441 mmol/L | Standard Deviation 1.6732 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 32 | -0.012 mmol/L | Standard Deviation 0.067 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 36 | -0.004 mmol/L | Standard Deviation 0.0534 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 28 | 0.086 mmol/L | Standard Deviation 2.5365 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 44 | -0.019 mmol/L | Standard Deviation 0.0839 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 1 | -0.017 mmol/L | Standard Deviation 0.3098 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 2 | -0.005 mmol/L | Standard Deviation 0.3521 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 36 | -0.618 mmol/L | Standard Deviation 1.985 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 4 | 0.024 mmol/L | Standard Deviation 0.403 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 24 | -0.306 mmol/L | Standard Deviation 2.1885 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 8 | -0.010 mmol/L | Standard Deviation 0.3135 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 12 | -0.082 mmol/L | Standard Deviation 0.3074 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 20 | 0.162 mmol/L | Standard Deviation 2.6616 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 16 | -0.037 mmol/L | Standard Deviation 0.3035 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 20 | -0.019 mmol/L | Standard Deviation 0.3627 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 40 | -0.882 mmol/L | Standard Deviation 1.9812 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 24 | -0.094 mmol/L | Standard Deviation 0.3414 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 16 | -0.184 mmol/L | Standard Deviation 2.2644 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 28 | -0.003 mmol/L | Standard Deviation 0.3312 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 32 | 0.056 mmol/L | Standard Deviation 0.2688 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 36 | 0.003 mmol/L | Standard Deviation 0.3205 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 8 | 0.538 mmol/L | Standard Deviation 2.3038 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 40 | -0.003 mmol/L | Standard Deviation 0.3407 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 44 | -0.647 mmol/L | Standard Deviation 1.8238 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 44 | 0.094 mmol/L | Standard Deviation 0.3084 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 48 | 0.003 mmol/L | Standard Deviation 0.4123 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 1 | -0.610 mmol/L | Standard Deviation 2.0722 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 4 | 0.024 mmol/L | Standard Deviation 2.6409 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 1 | 0.173 mmol/L | Standard Deviation 1.0232 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 2 | 0.129 mmol/L | Standard Deviation 1.2364 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 40 | -0.019 mmol/L | Standard Deviation 0.0809 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 48 | -0.253 mmol/L | Standard Deviation 0.6653 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 8 | 0.344 mmol/L | Standard Deviation 0.6939 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 2 | -0.244 mmol/L | Standard Deviation 2.0221 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 16 | 0.276 mmol/L | Standard Deviation 0.828 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 44 | -0.218 mmol/L | Standard Deviation 0.915 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 24 | 0.061 mmol/L | Standard Deviation 1.0462 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 32 | 0.356 mmol/L | Standard Deviation 1.1021 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 36 | 0.174 mmol/L | Standard Deviation 1.0175 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 44 | 0.303 mmol/L | Standard Deviation 1.276 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 2 | -0.019 mmol/L | Standard Deviation 0.0624 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 36 | -0.038 mmol/L | Standard Deviation 0.6597 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 4 | -0.707 mmol/L | Standard Deviation 2.0155 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 4 | -0.020 mmol/L | Standard Deviation 0.0712 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 32 | -0.050 mmol/L | Standard Deviation 0.5945 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 20 | -0.005 mmol/L | Standard Deviation 0.0724 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 24 | -0.009 mmol/L | Standard Deviation 0.0559 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 28 | -0.037 mmol/L | Standard Deviation 0.5801 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 28 | -0.019 mmol/L | Standard Deviation 0.0719 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 8 | 0.683 mmol/L | Standard Deviation 2.4025 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 24 | -0.725 mmol/L | Standard Deviation 1.7393 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 12 | -0.124 mmol/L | Standard Deviation 0.6636 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 20 | 0.115 mmol/L | Standard Deviation 0.7718 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 36 | 0.033 mmol/L | Standard Deviation 0.3359 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 2 | -0.007 mmol/L | Standard Deviation 0.068 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 24 | 0.077 mmol/L | Standard Deviation 0.5686 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 44 | 0.200 mmol/L | Standard Deviation 2.584 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 28 | -0.017 mmol/L | Standard Deviation 0.0565 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 40 | -0.017 mmol/L | Standard Deviation 0.3456 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 8 | 0.061 mmol/L | Standard Deviation 0.6268 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 24 | -0.016 mmol/L | Standard Deviation 0.0664 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 4 | 0.151 mmol/L | Standard Deviation 0.4178 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 8 | -0.022 mmol/L | Standard Deviation 0.0975 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 44 | -0.035 mmol/L | Standard Deviation 0.3009 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 4 | 0.000 mmol/L | Standard Deviation 2.6363 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 44 | -1.000 mmol/L | Standard Deviation 2.4179 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 1 | 0.102 mmol/L | Standard Deviation 0.3965 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 32 | -0.013 mmol/L | Standard Deviation 0.0572 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 48 | -0.027 mmol/L | Standard Deviation 0.325 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 40 | 0.500 mmol/L | Standard Deviation 2.4495 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 4 | -0.005 mmol/L | Standard Deviation 0.0998 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 1 | -0.375 mmol/L | Standard Deviation 2.1326 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 32 | 0.256 mmol/L | Standard Deviation 0.692 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 4 | -0.805 mmol/L | Standard Deviation 1.8196 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 1 | -0.060 mmol/L | Standard Deviation 0.8445 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 20 | -0.775 mmol/L | Standard Deviation 1.9147 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 48 | 0.725 mmol/L | Standard Deviation 2.7826 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 4 | -0.020 mmol/L | Standard Deviation 0.0917 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 2 | 0.190 mmol/L | Standard Deviation 0.8938 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 48 | -0.083 mmol/L | Standard Deviation 0.5817 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 44 | -0.016 mmol/L | Standard Deviation 0.0667 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 4 | 0.134 mmol/L | Standard Deviation 0.7428 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 2 | -0.439 mmol/L | Standard Deviation 2.4192 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 1 | -0.125 mmol/L | Standard Deviation 2.3986 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 48 | -0.034 mmol/L | Standard Deviation 0.0861 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 1 | -0.062 mmol/L | Standard Deviation 0.3216 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 8 | 0.256 mmol/L | Standard Deviation 0.7075 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 16 | -0.780 mmol/L | Standard Deviation 1.725 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 16 | 0.249 mmol/L | Standard Deviation 0.7075 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 2 | 0.222 mmol/L | Standard Deviation 0.6101 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 44 | -0.000 mmol/L | Standard Deviation 0.8407 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 2 | -0.341 mmol/L | Standard Deviation 2.1167 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 48 | -0.750 mmol/L | Standard Deviation 2.1334 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 48 | -0.009 mmol/L | Standard Deviation 0.0648 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 16 | 0.398 mmol/L | Standard Deviation 0.8332 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 16 | -0.002 mmol/L | Standard Deviation 0.0731 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 32 | -0.008 mmol/L | Standard Deviation 0.1024 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 28 | 0.100 mmol/L | Standard Deviation 0.5923 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 24 | 0.037 mmol/L | Standard Deviation 0.6295 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 28 | 0.262 mmol/L | Standard Deviation 0.6412 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 12 | -0.854 mmol/L | Standard Deviation 2.3512 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 8 | -0.463 mmol/L | Standard Deviation 2.2924 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 32 | 0.203 mmol/L | Standard Deviation 0.5945 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 28 | -0.021 mmol/L | Standard Deviation 0.1043 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 1 | -0.014 mmol/L | Standard Deviation 0.0897 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 24 | 0.003 mmol/L | Standard Deviation 0.0974 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 2 | 0.027 mmol/L | Standard Deviation 0.3074 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 24 | -0.050 mmol/L | Standard Deviation 2.5415 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 40 | -0.009 mmol/L | Standard Deviation 0.0684 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 36 | -0.007 mmol/L | Standard Deviation 0.0563 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 36 | 0.290 mmol/L | Standard Deviation 0.7789 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 4 | -0.063 mmol/L | Standard Deviation 0.2853 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 40 | 0.125 mmol/L | Standard Deviation 0.7016 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 36 | -0.436 mmol/L | Standard Deviation 2.2337 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 32 | -0.667 mmol/L | Standard Deviation 1.8257 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 20 | -0.018 mmol/L | Standard Deviation 0.0919 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 8 | 0.000 mmol/L | Standard Deviation 0.252 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 20 | 0.075 mmol/L | Standard Deviation 2.3685 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 28 | 0.250 mmol/L | Standard Deviation 2.509 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 12 | 0.003 mmol/L | Standard Deviation 0.073 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 2 | -0.022 mmol/L | Standard Deviation 0.0938 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 12 | -0.080 mmol/L | Standard Deviation 0.2977 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 12 | 0.212 mmol/L | Standard Deviation 0.7491 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 36 | -0.015 mmol/L | Standard Deviation 0.0936 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 8 | -0.006 mmol/L | Standard Deviation 0.0624 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 20 | -0.009 mmol/L | Standard Deviation 0.0636 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 16 | -0.020 mmol/L | Standard Deviation 0.2713 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 44 | -0.042 mmol/L | Standard Deviation 0.0972 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Magnesium Week 1 | -0.015 mmol/L | Standard Deviation 0.068 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 28 | -0.575 mmol/L | Standard Deviation 2.5609 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 44 | 0.197 mmol/L | Standard Deviation 0.8966 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 20 | 0.000 mmol/L | Standard Deviation 0.2774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 16 | -0.268 mmol/L | Standard Deviation 2.1334 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 48 | 0.100 mmol/L | Standard Deviation 0.7835 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 32 | 0.282 mmol/L | Standard Deviation 2.0641 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 40 | 0.110 mmol/L | Standard Deviation 0.7824 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 24 | -0.062 mmol/L | Standard Deviation 0.2967 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 16 | 0.005 mmol/L | Standard Deviation 0.0888 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Sodium Week 40 | -0.950 mmol/L | Standard Deviation 2.0248 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 36 | 0.205 mmol/L | Standard Deviation 2.4299 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 12 | -0.025 mmol/L | Standard Deviation 0.0923 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 28 | -0.030 mmol/L | Standard Deviation 0.348 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Chloride Week 12 | 0.000 mmol/L | Standard Deviation 2.4393 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium Week 40 | -0.025 mmol/L | Standard Deviation 0.0947 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Glucose Week 20 | 0.165 mmol/L | Standard Deviation 1.0366 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Cholesterol Week 36 | 0.144 mmol/L | Standard Deviation 0.795 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Potassium Week 32 | 0.046 mmol/L | Standard Deviation 0.3094 |
Secondary
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Urea nitrogen was measured in millimoles per liter (mmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 12 | -0.166 mmol/L | Standard Deviation 1.2654 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 2 | 0.386 mmol/L | Standard Deviation 1.8183 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 8 | 0.007 mmol/L | Standard Deviation 0.9936 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 4 | 0.027 mmol/L | Standard Deviation 1.3217 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 28 | -0.267 mmol/L | Standard Deviation 1.3487 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 36 | -0.203 mmol/L | Standard Deviation 1.0579 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 48 | -0.111 mmol/L | Standard Deviation 1.4431 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 24 | -0.256 mmol/L | Standard Deviation 1.1378 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 40 | -0.214 mmol/L | Standard Deviation 1.2537 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 20 | -0.207 mmol/L | Standard Deviation 1.267 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 44 | -0.105 mmol/L | Standard Deviation 1.3389 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 16 | -0.133 mmol/L | Standard Deviation 1.0656 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 1 | -0.093 mmol/L | Standard Deviation 1.0815 |
| Placebo (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 32 | -0.097 mmol/L | Standard Deviation 1.0396 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 12 | -0.244 mmol/L | Standard Deviation 1.174 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 20 | -0.490 mmol/L | Standard Deviation 1.0901 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 2 | -0.208 mmol/L | Standard Deviation 1.1329 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 32 | -0.141 mmol/L | Standard Deviation 1.3098 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 8 | 0.023 mmol/L | Standard Deviation 1.1685 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 16 | -0.087 mmol/L | Standard Deviation 0.9793 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 40 | 0.192 mmol/L | Standard Deviation 1.369 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 4 | 0.013 mmol/L | Standard Deviation 1.1307 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 44 | -0.047 mmol/L | Standard Deviation 1.3456 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 28 | -0.287 mmol/L | Standard Deviation 1.0992 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 24 | -0.523 mmol/L | Standard Deviation 1.1235 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 1 | 0.126 mmol/L | Standard Deviation 1.2116 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 36 | -0.308 mmol/L | Standard Deviation 1.1757 |
| BKZ 16 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 48 | -0.113 mmol/L | Standard Deviation 1.1796 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 24 | -0.232 mmol/L | Standard Deviation 1.4951 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 28 | 0.012 mmol/L | Standard Deviation 1.302 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 32 | -0.200 mmol/L | Standard Deviation 1.1266 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 36 | 0.015 mmol/L | Standard Deviation 1.1094 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 40 | 0.068 mmol/L | Standard Deviation 1.123 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 48 | -0.222 mmol/L | Standard Deviation 1.4085 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 1 | -0.123 mmol/L | Standard Deviation 1.0989 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 2 | -0.047 mmol/L | Standard Deviation 1.0359 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 4 | 0.083 mmol/L | Standard Deviation 1.1244 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 8 | -0.070 mmol/L | Standard Deviation 1.1143 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 12 | -0.231 mmol/L | Standard Deviation 1.3357 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 16 | -0.200 mmol/L | Standard Deviation 1.3083 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 20 | -0.064 mmol/L | Standard Deviation 1.2916 |
| BKZ 160 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 44 | -0.054 mmol/L | Standard Deviation 1.1276 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 8 | -0.379 mmol/L | Standard Deviation 1.2316 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 1 | -0.012 mmol/L | Standard Deviation 1.09 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 12 | -0.429 mmol/L | Standard Deviation 1.1733 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 48 | -0.285 mmol/L | Standard Deviation 1.2611 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 44 | -0.229 mmol/L | Standard Deviation 1.1979 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 16 | -0.218 mmol/L | Standard Deviation 1.0747 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 40 | -0.132 mmol/L | Standard Deviation 1.1834 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 20 | -0.357 mmol/L | Standard Deviation 1.1572 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 36 | -0.247 mmol/L | Standard Deviation 1.1683 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 32 | -0.326 mmol/L | Standard Deviation 1.1199 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 24 | -0.289 mmol/L | Standard Deviation 1.1369 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 4 | -0.224 mmol/L | Standard Deviation 1.1449 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 2 | 0.024 mmol/L | Standard Deviation 1.1762 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 28 | -0.263 mmol/L | Standard Deviation 1.1835 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 44 | 0.210 mmol/L | Standard Deviation 1.2264 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 8 | 0.080 mmol/L | Standard Deviation 1.1265 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 1 | 0.173 mmol/L | Standard Deviation 1.5513 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 40 | 0.283 mmol/L | Standard Deviation 1.3435 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 24 | -0.138 mmol/L | Standard Deviation 1.2245 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 20 | -0.035 mmol/L | Standard Deviation 1.3202 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 12 | -0.151 mmol/L | Standard Deviation 1.2426 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 48 | 0.088 mmol/L | Standard Deviation 1.458 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 28 | -0.082 mmol/L | Standard Deviation 1.3239 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 32 | 0.082 mmol/L | Standard Deviation 1.1841 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 2 | 0.212 mmol/L | Standard Deviation 1.3064 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 16 | 0.012 mmol/L | Standard Deviation 1.1996 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 4 | 0.007 mmol/L | Standard Deviation 1.2384 |
| BKZ 320 mg (FAS) | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Week 36 | -0.018 mmol/L | Standard Deviation 1.1014 |
Secondary
Changes From Baseline in Body Weight During the Study
Body weight was measured in kilograms.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.~Overall number of participants analyzed include only those for whom body weight was measured and analyzed during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Body Weight During the Study | Week 12 | 0.14 kilograms | Standard Deviation 3.38 |
| Placebo (FAS) | Changes From Baseline in Body Weight During the Study | Week 24 | 0.33 kilograms | Standard Deviation 4.1 |
| Placebo (FAS) | Changes From Baseline in Body Weight During the Study | Week 36 | 0.32 kilograms | Standard Deviation 5.15 |
| Placebo (FAS) | Changes From Baseline in Body Weight During the Study | Week 48 | 0.21 kilograms | Standard Deviation 4.42 |
| BKZ 16 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 12 | -0.87 kilograms | Standard Deviation 3.12 |
| BKZ 16 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 48 | 0.45 kilograms | Standard Deviation 3.41 |
| BKZ 16 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 24 | -0.03 kilograms | Standard Deviation 3.48 |
| BKZ 16 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 36 | -0.14 kilograms | Standard Deviation 2.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 48 | 0.80 kilograms | Standard Deviation 3.84 |
| BKZ 160 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 24 | -0.07 kilograms | Standard Deviation 2.63 |
| BKZ 160 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 36 | 0.27 kilograms | Standard Deviation 3.42 |
| BKZ 160 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 12 | 0.21 kilograms | Standard Deviation 1.78 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Body Weight During the Study | Week 12 | -0.38 kilograms | Standard Deviation 1.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Body Weight During the Study | Week 24 | -0.13 kilograms | Standard Deviation 2.37 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Body Weight During the Study | Week 48 | -0.14 kilograms | Standard Deviation 3.32 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Body Weight During the Study | Week 36 | 0.15 kilograms | Standard Deviation 2.36 |
| BKZ 320 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 48 | 0.11 kilograms | Standard Deviation 4.24 |
| BKZ 320 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 36 | -0.04 kilograms | Standard Deviation 4.19 |
| BKZ 320 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 24 | -0.39 kilograms | Standard Deviation 3.73 |
| BKZ 320 mg (FAS) | Changes From Baseline in Body Weight During the Study | Week 12 | -0.04 kilograms | Standard Deviation 2.39 |
Secondary
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
Time frame: Baseline, Week 12 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.~Overall number of participants analyzed include only those for whom electrocardiogram data was measured and analyzed during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 12 | 4.5 msec | Standard Deviation 27.5 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 48 | -2.5 msec | Standard Deviation 34.8 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 12 | -2.0 msec | Standard Deviation 46.6 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 48 | 5.6 msec | Standard Deviation 21.4 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 12 | 3.3 msec | Standard Deviation 99.3 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 12 | 2.6 msec | Standard Deviation 22.3 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 48 | -0.6 msec | Standard Deviation 116.1 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 48 | 2.6 msec | Standard Deviation 33.7 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 12 | -1.7 msec | Standard Deviation 23.3 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 12 | 3.4 msec | Standard Deviation 32.7 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 48 | -0.7 msec | Standard Deviation 33.4 |
| Placebo (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 48 | -0.1 msec | Standard Deviation 30.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 48 | 11.9 msec | Standard Deviation 187.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 12 | -2.8 msec | Standard Deviation 29.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 48 | -5.8 msec | Standard Deviation 36.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 12 | -2.5 msec | Standard Deviation 22.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 48 | -6.1 msec | Standard Deviation 31.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 12 | -1.0 msec | Standard Deviation 23.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 48 | 17.5 msec | Standard Deviation 128.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 12 | -2.9 msec | Standard Deviation 10.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 48 | -1.5 msec | Standard Deviation 16.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 12 | 1.7 msec | Standard Deviation 34 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 48 | 3.1 msec | Standard Deviation 29.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 12 | -22.5 msec | Standard Deviation 212.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 48 | 4.0 msec | Standard Deviation 163 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 48 | 3.9 msec | Standard Deviation 22.8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 12 | 9.5 msec | Standard Deviation 21.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 48 | -4.0 msec | Standard Deviation 13 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 12 | 75.8 msec | Standard Deviation 179.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 12 | -1.8 msec | Standard Deviation 7.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 12 | -5.6 msec | Standard Deviation 41.8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 12 | -19.6 msec | Standard Deviation 102.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 48 | -0.2 msec | Standard Deviation 15.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 48 | -5.9 msec | Standard Deviation 22.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 12 | -2.2 msec | Standard Deviation 14.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 48 | 65.2 msec | Standard Deviation 139 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 12 | -0.2 msec | Standard Deviation 5.4 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 48 | 44.3 msec | Standard Deviation 124 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 48 | -2.2 msec | Standard Deviation 20 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 12 | 3.2 msec | Standard Deviation 18.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 48 | 0.6 msec | Standard Deviation 16.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 48 | 5.4 msec | Standard Deviation 26.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 48 | 0.8 msec | Standard Deviation 18.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 12 | 11.0 msec | Standard Deviation 125.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 12 | 3.8 msec | Standard Deviation 25.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 48 | -4.7 msec | Standard Deviation 21 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 12 | 1.5 msec | Standard Deviation 18.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 12 | -0.5 msec | Standard Deviation 17 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 48 | -2.8 msec | Standard Deviation 26.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 48 | 0.1 msec | Standard Deviation 18.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 12 | -1.9 msec | Standard Deviation 31.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 12 | 11.5 msec | Standard Deviation 80.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | PR Week 12 | -9.5 msec | Standard Deviation 32.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 48 | 4.6 msec | Standard Deviation 44.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcB Week 48 | -5.7 msec | Standard Deviation 27.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QRS Week 12 | 6.1 msec | Standard Deviation 42.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QT Week 48 | 0.7 msec | Standard Deviation 31.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 48 | 25.1 msec | Standard Deviation 148.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | RR Week 12 | -17.0 msec | Standard Deviation 182.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | QTcF Week 12 | -3.0 msec | Standard Deviation 18.8 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10\^9/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.271 10^9 white blood cells per liter | Standard Deviation 1.1885 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 48 | 0.045 10^9 white blood cells per liter | Standard Deviation 0.1811 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 44 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.041 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 28 | 0.026 10^9 white blood cells per liter | Standard Deviation 0.2087 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 44 | 0.072 10^9 white blood cells per liter | Standard Deviation 0.1523 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 48 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.0462 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 40 | 0.050 10^9 white blood cells per liter | Standard Deviation 0.1444 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.086 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 48 | 0.066 10^9 white blood cells per liter | Standard Deviation 0.5313 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 36 | 0.054 10^9 white blood cells per liter | Standard Deviation 0.1726 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0731 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.200 10^9 white blood cells per liter | Standard Deviation 1.0959 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 32 | 0.049 10^9 white blood cells per liter | Standard Deviation 0.1502 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0987 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 28 | 0.036 10^9 white blood cells per liter | Standard Deviation 0.0986 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.024 10^9 white blood cells per liter | Standard Deviation 0.0969 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 24 | 0.031 10^9 white blood cells per liter | Standard Deviation 0.1301 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.020 10^9 white blood cells per liter | Standard Deviation 0.0954 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 20 | 0.036 10^9 white blood cells per liter | Standard Deviation 0.1038 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 16 | 0.045 10^9 white blood cells per liter | Standard Deviation 0.1253 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 44 | -0.008 10^9 white blood cells per liter | Standard Deviation 0.539 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.026 10^9 white blood cells per liter | Standard Deviation 1.1945 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 24 | -0.026 10^9 white blood cells per liter | Standard Deviation 0.1292 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 40 | 0.139 10^9 white blood cells per liter | Standard Deviation 0.4871 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.102 10^9 white blood cells per liter | Standard Deviation 1.0044 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 16 | -0.007 10^9 white blood cells per liter | Standard Deviation 0.1629 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 36 | 0.078 10^9 white blood cells per liter | Standard Deviation 0.4894 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | 0.249 10^9 white blood cells per liter | Standard Deviation 1.5358 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 32 | -0.000 10^9 white blood cells per liter | Standard Deviation 0.5109 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | 0.117 10^9 white blood cells per liter | Standard Deviation 1.5103 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 32 | 0.064 10^9 white blood cells per liter | Standard Deviation 0.2356 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 28 | 0.036 10^9 white blood cells per liter | Standard Deviation 0.5869 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 16 | -0.490 10^9 white blood cells per liter | Standard Deviation 1.6866 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 24 | -0.041 10^9 white blood cells per liter | Standard Deviation 0.3905 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 20 | -0.972 10^9 white blood cells per liter | Standard Deviation 1.2085 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 20 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.4934 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 24 | -1.210 10^9 white blood cells per liter | Standard Deviation 1.4067 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | 0.020 10^9 white blood cells per liter | Standard Deviation 0.1913 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 16 | 0.052 10^9 white blood cells per liter | Standard Deviation 0.5567 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 28 | -0.774 10^9 white blood cells per liter | Standard Deviation 1.8189 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 32 | -0.869 10^9 white blood cells per liter | Standard Deviation 1.2796 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 36 | 0.054 10^9 white blood cells per liter | Standard Deviation 0.1626 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.041 10^9 white blood cells per liter | Standard Deviation 0.3647 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.120 10^9 white blood cells per liter | Standard Deviation 0.3776 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 36 | -0.722 10^9 white blood cells per liter | Standard Deviation 1.6422 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.037 10^9 white blood cells per liter | Standard Deviation 0.4386 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 40 | -1.006 10^9 white blood cells per liter | Standard Deviation 1.7393 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.105 10^9 white blood cells per liter | Standard Deviation 0.3246 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 44 | -0.978 10^9 white blood cells per liter | Standard Deviation 1.2444 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | 0.059 10^9 white blood cells per liter | Standard Deviation 0.191 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | -0.083 10^9 white blood cells per liter | Standard Deviation 0.5074 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 48 | -0.861 10^9 white blood cells per liter | Standard Deviation 1.6858 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 48 | -0.739 10^9 white blood cells per liter | Standard Deviation 1.7774 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 44 | -1.065 10^9 white blood cells per liter | Standard Deviation 1.607 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 40 | 0.053 10^9 white blood cells per liter | Standard Deviation 0.1647 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 40 | -0.783 10^9 white blood cells per liter | Standard Deviation 1.7693 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 40 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0506 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 36 | -0.541 10^9 white blood cells per liter | Standard Deviation 1.5971 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | 0.032 10^9 white blood cells per liter | Standard Deviation 0.1588 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 32 | -0.762 10^9 white blood cells per liter | Standard Deviation 1.4273 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0387 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 20 | -0.008 10^9 white blood cells per liter | Standard Deviation 0.1783 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 28 | -0.700 10^9 white blood cells per liter | Standard Deviation 1.818 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0269 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0474 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 24 | -1.251 10^9 white blood cells per liter | Standard Deviation 1.3888 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | -0.002 10^9 white blood cells per liter | Standard Deviation 0.0353 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | 0.076 10^9 white blood cells per liter | Standard Deviation 0.1358 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 20 | -0.936 10^9 white blood cells per liter | Standard Deviation 1.2756 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0353 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 44 | 0.019 10^9 white blood cells per liter | Standard Deviation 0.1939 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 16 | -0.400 10^9 white blood cells per liter | Standard Deviation 1.5616 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 16 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.0431 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | 0.190 10^9 white blood cells per liter | Standard Deviation 1.6223 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 20 | -0.003 10^9 white blood cells per liter | Standard Deviation 0.0362 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | 0.429 10^9 white blood cells per liter | Standard Deviation 1.7036 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 24 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0397 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.049 10^9 white blood cells per liter | Standard Deviation 1.1938 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 28 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0394 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | 0.007 10^9 white blood cells per liter | Standard Deviation 0.2184 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | 0.157 10^9 white blood cells per liter | Standard Deviation 1.3195 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 32 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0324 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 36 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0408 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 48 | 0.021 10^9 white blood cells per liter | Standard Deviation 0.2145 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0283 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 48 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.1707 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 48 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.0754 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.011 10^9 white blood cells per liter | Standard Deviation 0.1673 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 16 | -0.050 10^9 white blood cells per liter | Standard Deviation 0.1673 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 44 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0372 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 36 | -0.992 10^9 white blood cells per liter | Standard Deviation 1.6583 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 44 | 0.019 10^9 white blood cells per liter | Standard Deviation 0.0908 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 36 | -0.024 10^9 white blood cells per liter | Standard Deviation 0.1792 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.024 10^9 white blood cells per liter | Standard Deviation 0.3259 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 48 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.291 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 48 | 0.103 10^9 white blood cells per liter | Standard Deviation 0.3645 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 40 | 0.018 10^9 white blood cells per liter | Standard Deviation 0.0865 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 24 | -0.884 10^9 white blood cells per liter | Standard Deviation 1.7768 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.333 10^9 white blood cells per liter | Standard Deviation 1.4014 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.016 10^9 white blood cells per liter | Standard Deviation 0.0718 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 40 | -0.992 10^9 white blood cells per liter | Standard Deviation 1.474 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 36 | 0.018 10^9 white blood cells per liter | Standard Deviation 0.0955 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 20 | -0.041 10^9 white blood cells per liter | Standard Deviation 0.1534 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.026 10^9 white blood cells per liter | Standard Deviation 0.4137 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.013 10^9 white blood cells per liter | Standard Deviation 0.0777 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.131 10^9 white blood cells per liter | Standard Deviation 2.1769 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 32 | 0.033 10^9 white blood cells per liter | Standard Deviation 0.0838 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0229 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 44 | -1.086 10^9 white blood cells per liter | Standard Deviation 1.6049 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.016 10^9 white blood cells per liter | Standard Deviation 0.0594 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.558 10^9 white blood cells per liter | Standard Deviation 0.9627 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 28 | 0.018 10^9 white blood cells per liter | Standard Deviation 0.0926 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 40 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0399 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | -0.024 10^9 white blood cells per liter | Standard Deviation 0.4142 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | -0.003 10^9 white blood cells per liter | Standard Deviation 0.0707 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 28 | 0.042 10^9 white blood cells per liter | Standard Deviation 0.1981 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 24 | 0.013 10^9 white blood cells per liter | Standard Deviation 0.0844 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 20 | -1.100 10^9 white blood cells per liter | Standard Deviation 1.5599 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 24 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0324 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.0882 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 44 | 0.105 10^9 white blood cells per liter | Standard Deviation 0.4136 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 20 | 0.026 10^9 white blood cells per liter | Standard Deviation 0.1186 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 48 | -0.939 10^9 white blood cells per liter | Standard Deviation 1.567 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.021 10^9 white blood cells per liter | Standard Deviation 0.1473 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 16 | 0.021 10^9 white blood cells per liter | Standard Deviation 0.0935 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 48 | -0.869 10^9 white blood cells per liter | Standard Deviation 1.7109 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.008 10^9 white blood cells per liter | Standard Deviation 0.1477 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.418 10^9 white blood cells per liter | Standard Deviation 1.1627 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 44 | -0.978 10^9 white blood cells per liter | Standard Deviation 1.8151 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 40 | 0.168 10^9 white blood cells per liter | Standard Deviation 0.4281 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.028 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0324 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.405 10^9 white blood cells per liter | Standard Deviation 1.1246 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.411 10^9 white blood cells per liter | Standard Deviation 1.1988 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 36 | 0.039 10^9 white blood cells per liter | Standard Deviation 0.4227 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 40 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.1323 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 40 | -0.826 10^9 white blood cells per liter | Standard Deviation 1.5942 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.346 10^9 white blood cells per liter | Standard Deviation 1.264 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.031 10^9 white blood cells per liter | Standard Deviation 0.1608 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 32 | 0.103 10^9 white blood cells per liter | Standard Deviation 0.4233 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 16 | -0.839 10^9 white blood cells per liter | Standard Deviation 1.8179 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 36 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0283 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.456 10^9 white blood cells per liter | Standard Deviation 1.1227 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.054 10^9 white blood cells per liter | Standard Deviation 0.3783 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 28 | 0.105 10^9 white blood cells per liter | Standard Deviation 0.3594 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 36 | -0.974 10^9 white blood cells per liter | Standard Deviation 1.7389 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 32 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.032 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 16 | -0.879 10^9 white blood cells per liter | Standard Deviation 1.5752 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 32 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.1731 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 24 | 0.050 10^9 white blood cells per liter | Standard Deviation 0.363 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 32 | -0.862 10^9 white blood cells per liter | Standard Deviation 2.0091 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 16 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0324 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 20 | -1.069 10^9 white blood cells per liter | Standard Deviation 1.4219 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 24 | -0.034 10^9 white blood cells per liter | Standard Deviation 0.1361 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 20 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.397 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 44 | -0.008 10^9 white blood cells per liter | Standard Deviation 0.1588 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.438 10^9 white blood cells per liter | Standard Deviation 1.3854 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 24 | -0.895 10^9 white blood cells per liter | Standard Deviation 1.6288 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0329 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 16 | 0.071 10^9 white blood cells per liter | Standard Deviation 0.3571 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 28 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0329 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 28 | -0.316 10^9 white blood cells per liter | Standard Deviation 2.3086 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 28 | -0.484 10^9 white blood cells per liter | Standard Deviation 2.262 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.041 10^9 white blood cells per liter | Standard Deviation 0.1743 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.051 10^9 white blood cells per liter | Standard Deviation 0.4167 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.597 10^9 white blood cells per liter | Standard Deviation 1.149 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 32 | -0.969 10^9 white blood cells per liter | Standard Deviation 1.8241 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 20 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0362 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 20 | -0.015 10^9 white blood cells per liter | Standard Deviation 0.1509 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 24 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.1476 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 28 | 0.055 10^9 white blood cells per liter | Standard Deviation 0.1724 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 32 | -0.003 10^9 white blood cells per liter | Standard Deviation 0.1271 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 36 | 0.032 10^9 white blood cells per liter | Standard Deviation 0.1404 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 40 | 0.020 10^9 white blood cells per liter | Standard Deviation 0.1636 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 44 | 0.044 10^9 white blood cells per liter | Standard Deviation 0.1644 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 48 | -0.013 10^9 white blood cells per liter | Standard Deviation 0.1399 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.693 10^9 white blood cells per liter | Standard Deviation 1.2971 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.337 10^9 white blood cells per liter | Standard Deviation 1.3109 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.290 10^9 white blood cells per liter | Standard Deviation 1.3463 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.256 10^9 white blood cells per liter | Standard Deviation 1.3898 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.458 10^9 white blood cells per liter | Standard Deviation 1.6879 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 16 | -0.617 10^9 white blood cells per liter | Standard Deviation 1.6027 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 20 | -0.595 10^9 white blood cells per liter | Standard Deviation 1.4319 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 24 | -0.593 10^9 white blood cells per liter | Standard Deviation 1.5309 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 28 | -0.555 10^9 white blood cells per liter | Standard Deviation 1.2608 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 32 | -0.433 10^9 white blood cells per liter | Standard Deviation 1.7889 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 36 | -0.541 10^9 white blood cells per liter | Standard Deviation 1.5519 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 40 | -0.575 10^9 white blood cells per liter | Standard Deviation 1.9567 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 44 | -0.717 10^9 white blood cells per liter | Standard Deviation 1.6966 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 48 | -0.558 10^9 white blood cells per liter | Standard Deviation 1.7944 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | -0.007 10^9 white blood cells per liter | Standard Deviation 0.0463 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 32 | -0.010 10^9 white blood cells per liter | Standard Deviation 0.0441 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | -0.002 10^9 white blood cells per liter | Standard Deviation 0.0408 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0488 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.0384 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | -0.002 10^9 white blood cells per liter | Standard Deviation 0.0462 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 16 | -0.007 10^9 white blood cells per liter | Standard Deviation 0.0463 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 20 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.05 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 24 | -0.003 10^9 white blood cells per liter | Standard Deviation 0.053 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 28 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.0526 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 36 | -0.002 10^9 white blood cells per liter | Standard Deviation 0.0474 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 40 | -0.010 10^9 white blood cells per liter | Standard Deviation 0.0379 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 44 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0387 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 48 | -0.010 10^9 white blood cells per liter | Standard Deviation 0.0441 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | -0.002 10^9 white blood cells per liter | Standard Deviation 0.0801 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0913 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.078 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0831 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 16 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.0759 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 20 | 0.024 10^9 white blood cells per liter | Standard Deviation 0.1157 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 24 | 0.058 10^9 white blood cells per liter | Standard Deviation 0.2111 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 28 | 0.053 10^9 white blood cells per liter | Standard Deviation 0.1826 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 32 | 0.020 10^9 white blood cells per liter | Standard Deviation 0.1418 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 36 | 0.022 10^9 white blood cells per liter | Standard Deviation 0.0909 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 40 | 0.018 10^9 white blood cells per liter | Standard Deviation 0.0958 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 44 | 0.024 10^9 white blood cells per liter | Standard Deviation 0.0994 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 48 | 0.023 10^9 white blood cells per liter | Standard Deviation 0.0891 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.656 10^9 white blood cells per liter | Standard Deviation 1.2593 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.309 10^9 white blood cells per liter | Standard Deviation 1.3735 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.336 10^9 white blood cells per liter | Standard Deviation 1.5088 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.185 10^9 white blood cells per liter | Standard Deviation 1.2889 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.495 10^9 white blood cells per liter | Standard Deviation 1.6904 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 16 | -0.590 10^9 white blood cells per liter | Standard Deviation 1.4668 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 20 | -0.432 10^9 white blood cells per liter | Standard Deviation 1.3032 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 24 | -0.495 10^9 white blood cells per liter | Standard Deviation 1.4216 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 28 | -0.100 10^9 white blood cells per liter | Standard Deviation 1.4942 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 32 | -0.330 10^9 white blood cells per liter | Standard Deviation 1.575 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 36 | -0.366 10^9 white blood cells per liter | Standard Deviation 1.4549 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 40 | -0.437 10^9 white blood cells per liter | Standard Deviation 1.7878 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 44 | -0.537 10^9 white blood cells per liter | Standard Deviation 1.5641 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 48 | -0.473 10^9 white blood cells per liter | Standard Deviation 1.7104 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.044 10^9 white blood cells per liter | Standard Deviation 0.5039 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.021 10^9 white blood cells per liter | Standard Deviation 0.6006 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.6003 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.063 10^9 white blood cells per liter | Standard Deviation 0.5928 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.564 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 16 | 0.026 10^9 white blood cells per liter | Standard Deviation 0.5539 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 20 | 0.149 10^9 white blood cells per liter | Standard Deviation 0.4675 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 24 | 0.048 10^9 white blood cells per liter | Standard Deviation 0.4455 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 28 | 0.210 10^9 white blood cells per liter | Standard Deviation 0.5999 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 32 | 0.083 10^9 white blood cells per liter | Standard Deviation 0.6524 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 36 | 0.134 10^9 white blood cells per liter | Standard Deviation 0.5673 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 40 | 0.120 10^9 white blood cells per liter | Standard Deviation 0.6018 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 44 | 0.124 10^9 white blood cells per liter | Standard Deviation 0.5366 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 48 | 0.078 10^9 white blood cells per liter | Standard Deviation 0.5041 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.012 10^9 white blood cells per liter | Standard Deviation 0.1679 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | 0.014 10^9 white blood cells per liter | Standard Deviation 0.1897 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.040 10^9 white blood cells per liter | Standard Deviation 0.1862 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.158 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.033 10^9 white blood cells per liter | Standard Deviation 0.1686 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 16 | -0.024 10^9 white blood cells per liter | Standard Deviation 0.1265 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.880 10^9 white blood cells per liter | Standard Deviation 1.8457 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -1.029 10^9 white blood cells per liter | Standard Deviation 1.6496 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 28 | 0.011 10^9 white blood cells per liter | Standard Deviation 0.0323 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 48 | 0.019 10^9 white blood cells per liter | Standard Deviation 0.3763 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.954 10^9 white blood cells per liter | Standard Deviation 2.0441 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 24 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.0368 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -1.017 10^9 white blood cells per liter | Standard Deviation 1.9397 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 20 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0329 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -1.071 10^9 white blood cells per liter | Standard Deviation 1.9639 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 16 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0329 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 44 | -0.032 10^9 white blood cells per liter | Standard Deviation 0.2446 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.997 10^9 white blood cells per liter | Standard Deviation 2.1806 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0329 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 20 | -0.081 10^9 white blood cells per liter | Standard Deviation 0.2448 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 16 | -1.318 10^9 white blood cells per liter | Standard Deviation 2.3324 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.003 10^9 white blood cells per liter | Standard Deviation 0.0367 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.088 10^9 white blood cells per liter | Standard Deviation 0.2315 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 20 | -0.932 10^9 white blood cells per liter | Standard Deviation 2.2832 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0312 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 24 | -1.119 10^9 white blood cells per liter | Standard Deviation 2.2807 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.007 10^9 white blood cells per liter | Standard Deviation 0.0264 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 28 | -0.894 10^9 white blood cells per liter | Standard Deviation 1.7119 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 40 | -0.059 10^9 white blood cells per liter | Standard Deviation 0.283 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 32 | -0.918 10^9 white blood cells per liter | Standard Deviation 2.6184 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 40 | 0.038 10^9 white blood cells per liter | Standard Deviation 0.4335 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 16 | -0.079 10^9 white blood cells per liter | Standard Deviation 0.2384 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 36 | -1.082 10^9 white blood cells per liter | Standard Deviation 2.3389 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 32 | 0.009 10^9 white blood cells per liter | Standard Deviation 0.0379 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.095 10^9 white blood cells per liter | Standard Deviation 0.2701 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 40 | -1.226 10^9 white blood cells per liter | Standard Deviation 2.3856 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0316 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 44 | -1.032 10^9 white blood cells per liter | Standard Deviation 2.1585 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 48 | -1.178 10^9 white blood cells per liter | Standard Deviation 2.6503 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 48 | -1.225 10^9 white blood cells per liter | Standard Deviation 2.5952 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 44 | -1.109 10^9 white blood cells per liter | Standard Deviation 2.2673 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.066 10^9 white blood cells per liter | Standard Deviation 0.2404 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | -0.017 10^9 white blood cells per liter | Standard Deviation 0.4189 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 40 | -1.229 10^9 white blood cells per liter | Standard Deviation 2.4065 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.007 10^9 white blood cells per liter | Standard Deviation 0.3643 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 36 | -1.185 10^9 white blood cells per liter | Standard Deviation 2.1881 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 36 | -0.036 10^9 white blood cells per liter | Standard Deviation 0.2644 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | -0.032 10^9 white blood cells per liter | Standard Deviation 0.3996 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.053 10^9 white blood cells per liter | Standard Deviation 0.498 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 32 | -1.038 10^9 white blood cells per liter | Standard Deviation 2.48 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 28 | -0.949 10^9 white blood cells per liter | Standard Deviation 1.7676 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 24 | -0.056 10^9 white blood cells per liter | Standard Deviation 0.2602 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | -0.047 10^9 white blood cells per liter | Standard Deviation 0.3703 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 24 | -1.011 10^9 white blood cells per liter | Standard Deviation 2.2968 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.103 10^9 white blood cells per liter | Standard Deviation 0.252 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 16 | -0.029 10^9 white blood cells per liter | Standard Deviation 0.4991 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 20 | -0.827 10^9 white blood cells per liter | Standard Deviation 2.2663 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 20 | -0.035 10^9 white blood cells per liter | Standard Deviation 0.4566 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 16 | -1.203 10^9 white blood cells per liter | Standard Deviation 2.284 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 32 | -0.035 10^9 white blood cells per liter | Standard Deviation 0.2684 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 24 | -0.036 10^9 white blood cells per liter | Standard Deviation 0.3788 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.832 10^9 white blood cells per liter | Standard Deviation 2.2192 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 28 | 0.103 10^9 white blood cells per liter | Standard Deviation 0.5544 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -1.021 10^9 white blood cells per liter | Standard Deviation 1.7129 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 32 | 0.112 10^9 white blood cells per liter | Standard Deviation 0.5056 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.924 10^9 white blood cells per liter | Standard Deviation 1.9975 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.105 10^9 white blood cells per liter | Standard Deviation 0.263 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 36 | 0.103 10^9 white blood cells per liter | Standard Deviation 0.5491 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 36 | 0.012 10^9 white blood cells per liter | Standard Deviation 0.0415 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 16 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.1559 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | -0.026 10^9 white blood cells per liter | Standard Deviation 0.1155 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 20 | -0.014 10^9 white blood cells per liter | Standard Deviation 0.1228 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.0941 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 24 | -0.019 10^9 white blood cells per liter | Standard Deviation 0.1238 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0999 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.934 10^9 white blood cells per liter | Standard Deviation 1.4768 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 28 | -0.000 10^9 white blood cells per liter | Standard Deviation 0.1213 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.088 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 28 | -0.029 10^9 white blood cells per liter | Standard Deviation 0.2729 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 32 | 0.024 10^9 white blood cells per liter | Standard Deviation 0.1577 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.0999 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 44 | 0.115 10^9 white blood cells per liter | Standard Deviation 0.4881 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 36 | 0.027 10^9 white blood cells per liter | Standard Deviation 0.1526 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 48 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.0354 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 40 | 0.015 10^9 white blood cells per liter | Standard Deviation 0.1971 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 44 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.0422 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 44 | -0.009 10^9 white blood cells per liter | Standard Deviation 0.1798 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 40 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.0343 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 48 | -0.078 10^9 white blood cells per liter | Standard Deviation 0.2511 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 48 | 0.009 10^9 white blood cells per liter | Standard Deviation 0.2833 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.095 10^9 white blood cells per liter | Standard Deviation 0.3263 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 32 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.0384 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 24 | -0.027 10^9 white blood cells per liter | Standard Deviation 0.1921 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 32 | -0.718 10^9 white blood cells per liter | Standard Deviation 1.4299 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.285 10^9 white blood cells per liter | Standard Deviation 1.6896 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 28 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.045 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 32 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.1744 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 32 | 0.041 10^9 white blood cells per liter | Standard Deviation 0.1141 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.129 10^9 white blood cells per liter | Standard Deviation 0.3939 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.322 10^9 white blood cells per liter | Standard Deviation 1.5501 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 24 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0389 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 16 | 0.033 10^9 white blood cells per liter | Standard Deviation 0.0829 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 48 | 0.072 10^9 white blood cells per liter | Standard Deviation 0.3755 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.017 10^9 white blood cells per liter | Standard Deviation 0.0704 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.656 10^9 white blood cells per liter | Standard Deviation 1.4264 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 20 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0397 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.017 10^9 white blood cells per liter | Standard Deviation 0.0636 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 44 | -0.019 10^9 white blood cells per liter | Standard Deviation 0.2202 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.059 10^9 white blood cells per liter | Standard Deviation 0.1414 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.629 10^9 white blood cells per liter | Standard Deviation 1.5489 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 16 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.0417 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.061 10^9 white blood cells per liter | Standard Deviation 0.3301 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 24 | -0.850 10^9 white blood cells per liter | Standard Deviation 1.6461 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 44 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0338 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.634 10^9 white blood cells per liter | Standard Deviation 1.6084 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.010 10^9 white blood cells per liter | Standard Deviation 0.0374 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 20 | 0.038 10^9 white blood cells per liter | Standard Deviation 0.0935 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0669 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 16 | 0.135 10^9 white blood cells per liter | Standard Deviation 0.4197 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 16 | -0.293 10^9 white blood cells per liter | Standard Deviation 1.8427 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.002 10^9 white blood cells per liter | Standard Deviation 0.0418 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 20 | -0.618 10^9 white blood cells per liter | Standard Deviation 1.5716 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 40 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0403 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.071 10^9 white blood cells per liter | Standard Deviation 0.1834 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 20 | -0.455 10^9 white blood cells per liter | Standard Deviation 1.7116 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0312 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.325 10^9 white blood cells per liter | Standard Deviation 1.572 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.027 10^9 white blood cells per liter | Standard Deviation 0.1724 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 20 | 0.126 10^9 white blood cells per liter | Standard Deviation 0.4216 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 24 | -0.765 10^9 white blood cells per liter | Standard Deviation 1.8691 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.008 10^9 white blood cells per liter | Standard Deviation 0.035 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 16 | -0.448 10^9 white blood cells per liter | Standard Deviation 1.6816 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 40 | -0.018 10^9 white blood cells per liter | Standard Deviation 0.1504 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 48 | -0.077 10^9 white blood cells per liter | Standard Deviation 0.1709 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 28 | -0.342 10^9 white blood cells per liter | Standard Deviation 1.5683 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 28 | -0.568 10^9 white blood cells per liter | Standard Deviation 1.3889 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.010 10^9 white blood cells per liter | Standard Deviation 0.1882 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 24 | 0.037 10^9 white blood cells per liter | Standard Deviation 0.1192 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.027 10^9 white blood cells per liter | Standard Deviation 0.0895 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 32 | -0.505 10^9 white blood cells per liter | Standard Deviation 1.48 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 40 | 0.176 10^9 white blood cells per liter | Standard Deviation 0.3709 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 24 | 0.053 10^9 white blood cells per liter | Standard Deviation 0.3974 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.673 10^9 white blood cells per liter | Standard Deviation 1.3887 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 36 | 0.015 10^9 white blood cells per liter | Standard Deviation 0.0961 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 36 | -0.126 10^9 white blood cells per liter | Standard Deviation 2.2565 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 36 | 0.013 10^9 white blood cells per liter | Standard Deviation 0.0409 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 28 | -0.012 10^9 white blood cells per liter | Standard Deviation 0.1911 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 48 | 0.000 10^9 white blood cells per liter | Standard Deviation 0.0324 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 28 | 0.172 10^9 white blood cells per liter | Standard Deviation 0.3776 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 40 | -0.266 10^9 white blood cells per liter | Standard Deviation 1.7976 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.005 10^9 white blood cells per liter | Standard Deviation 0.0384 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.717 10^9 white blood cells per liter | Standard Deviation 1.4589 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 36 | 0.049 10^9 white blood cells per liter | Standard Deviation 0.2327 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 48 | -0.005 10^9 white blood cells per liter | Standard Deviation 0.0857 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 44 | -0.825 10^9 white blood cells per liter | Standard Deviation 1.8917 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 48 | -0.805 10^9 white blood cells per liter | Standard Deviation 1.6631 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 20 | -0.003 10^9 white blood cells per liter | Standard Deviation 0.1899 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 16 | -0.043 10^9 white blood cells per liter | Standard Deviation 0.1752 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 28 | 0.025 10^9 white blood cells per liter | Standard Deviation 0.087 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 48 | -0.777 10^9 white blood cells per liter | Standard Deviation 1.8593 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 44 | -0.983 10^9 white blood cells per liter | Standard Deviation 1.6556 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 32 | 0.146 10^9 white blood cells per liter | Standard Deviation 0.3966 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.732 10^9 white blood cells per liter | Standard Deviation 1.4028 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.029 10^9 white blood cells per liter | Standard Deviation 0.0929 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.020 10^9 white blood cells per liter | Standard Deviation 0.3006 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 40 | -0.495 10^9 white blood cells per liter | Standard Deviation 1.5857 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 44 | 0.153 10^9 white blood cells per liter | Standard Deviation 0.4462 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.085 10^9 white blood cells per liter | Standard Deviation 0.1459 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 44 | 0.006 10^9 white blood cells per liter | Standard Deviation 0.0893 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.161 10^9 white blood cells per liter | Standard Deviation 0.4277 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 36 | -0.354 10^9 white blood cells per liter | Standard Deviation 2.1441 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 36 | 0.118 10^9 white blood cells per liter | Standard Deviation 0.381 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.537 10^9 white blood cells per liter | Standard Deviation 1.3989 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 40 | 0.039 10^9 white blood cells per liter | Standard Deviation 0.1128 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 48 | 0.061 10^12 red blood cells per liter | Standard Deviation 0.2693 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 8 | -0.135 10^12 red blood cells per liter | Standard Deviation 0.2546 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 28 | -0.034 10^12 red blood cells per liter | Standard Deviation 0.2453 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 16 | -0.020 10^12 red blood cells per liter | Standard Deviation 0.2375 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 2 | -0.149 10^12 red blood cells per liter | Standard Deviation 0.2244 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 1 | -0.148 10^12 red blood cells per liter | Standard Deviation 0.2071 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 12 | -0.131 10^12 red blood cells per liter | Standard Deviation 0.2678 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 24 | 0.059 10^12 red blood cells per liter | Standard Deviation 0.2639 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 36 | 0.044 10^12 red blood cells per liter | Standard Deviation 0.2524 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 32 | -0.010 10^12 red blood cells per liter | Standard Deviation 0.2461 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 40 | 0.079 10^12 red blood cells per liter | Standard Deviation 0.2682 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 20 | 0.036 10^12 red blood cells per liter | Standard Deviation 0.2618 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 44 | 0.035 10^12 red blood cells per liter | Standard Deviation 0.2645 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 4 | -0.132 10^12 red blood cells per liter | Standard Deviation 0.278 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 28 | 0.108 10^12 red blood cells per liter | Standard Deviation 0.2681 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 48 | 0.146 10^12 red blood cells per liter | Standard Deviation 0.2994 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 32 | 0.104 10^12 red blood cells per liter | Standard Deviation 0.266 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 36 | 0.166 10^12 red blood cells per liter | Standard Deviation 0.2542 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 2 | -0.029 10^12 red blood cells per liter | Standard Deviation 0.1788 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 8 | -0.011 10^12 red blood cells per liter | Standard Deviation 0.2206 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 4 | 0.018 10^12 red blood cells per liter | Standard Deviation 0.2535 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 12 | 0.021 10^12 red blood cells per liter | Standard Deviation 0.2561 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 44 | 0.146 10^12 red blood cells per liter | Standard Deviation 0.2846 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 16 | 0.075 10^12 red blood cells per liter | Standard Deviation 0.2898 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 1 | -0.008 10^12 red blood cells per liter | Standard Deviation 0.1927 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 20 | 0.096 10^12 red blood cells per liter | Standard Deviation 0.2855 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 24 | 0.110 10^12 red blood cells per liter | Standard Deviation 0.2974 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 40 | 0.177 10^12 red blood cells per liter | Standard Deviation 0.2733 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 48 | 0.141 10^12 red blood cells per liter | Standard Deviation 0.2747 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 4 | 0.023 10^12 red blood cells per liter | Standard Deviation 0.2135 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 2 | -0.004 10^12 red blood cells per liter | Standard Deviation 0.228 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 28 | 0.122 10^12 red blood cells per liter | Standard Deviation 0.2445 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 20 | 0.068 10^12 red blood cells per liter | Standard Deviation 0.2089 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 1 | 0.050 10^12 red blood cells per liter | Standard Deviation 0.1773 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 40 | 0.163 10^12 red blood cells per liter | Standard Deviation 0.2736 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 36 | 0.156 10^12 red blood cells per liter | Standard Deviation 0.2849 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 12 | 0.069 10^12 red blood cells per liter | Standard Deviation 0.2419 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 44 | 0.133 10^12 red blood cells per liter | Standard Deviation 0.2622 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 32 | 0.133 10^12 red blood cells per liter | Standard Deviation 0.2716 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 8 | 0.074 10^12 red blood cells per liter | Standard Deviation 0.2466 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 24 | 0.142 10^12 red blood cells per liter | Standard Deviation 0.2573 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 16 | 0.047 10^12 red blood cells per liter | Standard Deviation 0.281 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 36 | 0.161 10^12 red blood cells per liter | Standard Deviation 0.2399 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 1 | 0.008 10^12 red blood cells per liter | Standard Deviation 0.2109 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 4 | 0.013 10^12 red blood cells per liter | Standard Deviation 0.1955 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 8 | 0.014 10^12 red blood cells per liter | Standard Deviation 0.219 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 12 | 0.051 10^12 red blood cells per liter | Standard Deviation 0.2243 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 16 | 0.074 10^12 red blood cells per liter | Standard Deviation 0.2255 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 20 | 0.064 10^12 red blood cells per liter | Standard Deviation 0.2273 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 24 | 0.074 10^12 red blood cells per liter | Standard Deviation 0.225 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 28 | 0.058 10^12 red blood cells per liter | Standard Deviation 0.2359 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 32 | 0.061 10^12 red blood cells per liter | Standard Deviation 0.2555 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 2 | -0.063 10^12 red blood cells per liter | Standard Deviation 0.2236 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 40 | 0.141 10^12 red blood cells per liter | Standard Deviation 0.2535 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 44 | 0.188 10^12 red blood cells per liter | Standard Deviation 0.2933 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 48 | 0.135 10^12 red blood cells per liter | Standard Deviation 0.2934 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 24 | 0.110 10^12 red blood cells per liter | Standard Deviation 0.1931 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 20 | 0.081 10^12 red blood cells per liter | Standard Deviation 0.2191 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 2 | 0.000 10^12 red blood cells per liter | Standard Deviation 0.1809 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 40 | 0.129 10^12 red blood cells per liter | Standard Deviation 0.2403 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 16 | 0.110 10^12 red blood cells per liter | Standard Deviation 0.2533 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 12 | 0.075 10^12 red blood cells per liter | Standard Deviation 0.2393 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 8 | 0.026 10^12 red blood cells per liter | Standard Deviation 0.2264 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 48 | 0.129 10^12 red blood cells per liter | Standard Deviation 0.2354 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 44 | 0.135 10^12 red blood cells per liter | Standard Deviation 0.2128 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 4 | 0.031 10^12 red blood cells per liter | Standard Deviation 0.2065 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 32 | 0.156 10^12 red blood cells per liter | Standard Deviation 0.2714 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 1 | -0.017 10^12 red blood cells per liter | Standard Deviation 0.1609 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 36 | 0.145 10^12 red blood cells per liter | Standard Deviation 0.2377 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Week 28 | 0.106 10^12 red blood cells per liter | Standard Deviation 0.2567 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.073 picograms (pg) | Standard Deviation 0.498 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 28 | -0.103 picograms (pg) | Standard Deviation 1.0101 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 20 | -0.290 picograms (pg) | Standard Deviation 0.8145 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 24 | -0.249 picograms (pg) | Standard Deviation 1.0443 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 44 | 0.097 picograms (pg) | Standard Deviation 1.3103 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | -0.112 picograms (pg) | Standard Deviation 0.5501 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 40 | -0.170 picograms (pg) | Standard Deviation 1.3453 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.110 picograms (pg) | Standard Deviation 0.6778 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 48 | 0.137 picograms (pg) | Standard Deviation 1.4139 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 36 | -0.082 picograms (pg) | Standard Deviation 1.3242 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.285 picograms (pg) | Standard Deviation 0.677 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | -0.050 picograms (pg) | Standard Deviation 0.389 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 32 | 0.003 picograms (pg) | Standard Deviation 1.2619 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 16 | -0.233 picograms (pg) | Standard Deviation 0.7281 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 16 | 0.097 picograms (pg) | Standard Deviation 0.8824 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | 0.023 picograms (pg) | Standard Deviation 0.7253 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | 0.141 picograms (pg) | Standard Deviation 0.6801 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 20 | -0.033 picograms (pg) | Standard Deviation 0.9172 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.126 picograms (pg) | Standard Deviation 0.5149 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 24 | 0.108 picograms (pg) | Standard Deviation 0.9947 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 28 | 0.029 picograms (pg) | Standard Deviation 0.7241 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | 0.058 picograms (pg) | Standard Deviation 0.4624 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 44 | 0.129 picograms (pg) | Standard Deviation 0.8742 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 36 | 0.237 picograms (pg) | Standard Deviation 0.8722 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 32 | 0.297 picograms (pg) | Standard Deviation 0.8561 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.089 picograms (pg) | Standard Deviation 0.5584 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 48 | 0.178 picograms (pg) | Standard Deviation 0.9369 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 40 | 0.134 picograms (pg) | Standard Deviation 0.896 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 16 | 0.014 picograms (pg) | Standard Deviation 0.9236 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.049 picograms (pg) | Standard Deviation 0.405 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.023 picograms (pg) | Standard Deviation 0.4225 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.060 picograms (pg) | Standard Deviation 0.591 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | 0.007 picograms (pg) | Standard Deviation 0.5926 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | 0.091 picograms (pg) | Standard Deviation 0.8358 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 20 | 0.029 picograms (pg) | Standard Deviation 0.9819 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 24 | -0.057 picograms (pg) | Standard Deviation 1.1804 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 28 | -0.122 picograms (pg) | Standard Deviation 1.113 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 32 | 0.058 picograms (pg) | Standard Deviation 1.1522 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 36 | -0.093 picograms (pg) | Standard Deviation 1.0792 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 40 | -0.134 picograms (pg) | Standard Deviation 1.2095 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 44 | -0.080 picograms (pg) | Standard Deviation 1.1771 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 48 | -0.120 picograms (pg) | Standard Deviation 1.1279 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 16 | -0.118 picograms (pg) | Standard Deviation 0.844 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 28 | -0.211 picograms (pg) | Standard Deviation 0.8277 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.132 picograms (pg) | Standard Deviation 0.8335 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 32 | 0.026 picograms (pg) | Standard Deviation 0.7684 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | 0.034 picograms (pg) | Standard Deviation 0.6851 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | 0.073 picograms (pg) | Standard Deviation 0.3975 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 36 | -0.248 picograms (pg) | Standard Deviation 0.8581 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.012 picograms (pg) | Standard Deviation 0.4691 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 40 | -0.147 picograms (pg) | Standard Deviation 0.8645 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.066 picograms (pg) | Standard Deviation 0.4357 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 48 | -0.030 picograms (pg) | Standard Deviation 0.7888 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 20 | -0.035 picograms (pg) | Standard Deviation 0.7013 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 44 | -0.159 picograms (pg) | Standard Deviation 0.748 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 24 | -0.097 picograms (pg) | Standard Deviation 0.7284 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 20 | 0.075 picograms (pg) | Standard Deviation 1.0824 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 48 | 0.140 picograms (pg) | Standard Deviation 1.2161 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 28 | 0.020 picograms (pg) | Standard Deviation 1.295 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | 0.039 picograms (pg) | Standard Deviation 1.0454 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 24 | -0.007 picograms (pg) | Standard Deviation 1.2338 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.055 picograms (pg) | Standard Deviation 0.4455 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 40 | 0.034 picograms (pg) | Standard Deviation 1.0839 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 32 | 0.167 picograms (pg) | Standard Deviation 1.2472 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | 0.095 picograms (pg) | Standard Deviation 0.7994 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.085 picograms (pg) | Standard Deviation 0.4287 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 16 | -0.067 picograms (pg) | Standard Deviation 1.1713 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 44 | 0.108 picograms (pg) | Standard Deviation 1.2532 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 36 | 0.118 picograms (pg) | Standard Deviation 1.1473 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.066 picograms (pg) | Standard Deviation 0.6085 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 40 | 3.108 g/L | Standard Deviation 9.8736 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | -4.561 g/L | Standard Deviation 7.0995 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 44 | 6.297 g/L | Standard Deviation 10.6975 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -4.390 g/L | Standard Deviation 7.5162 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 48 | 5.079 g/L | Standard Deviation 10.4916 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 40 | 1.432 g/L | Standard Deviation 9.109 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -4.810 g/L | Standard Deviation 6.5154 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -4.854 g/L | Standard Deviation 5.6726 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -5.195 g/L | Standard Deviation 11.7158 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 48 | 2.474 g/L | Standard Deviation 9.7002 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | -2.293 g/L | Standard Deviation 8.4594 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -7.927 g/L | Standard Deviation 14.6704 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | -2.310 g/L | Standard Deviation 7.9923 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 36 | 0.947 g/L | Standard Deviation 9.1738 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 16 | -6.286 g/L | Standard Deviation 12.3393 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 32 | -0.282 g/L | Standard Deviation 8.2684 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 20 | -5.050 g/L | Standard Deviation 12.8102 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 28 | -1.513 g/L | Standard Deviation 8.0259 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 24 | 1.000 g/L | Standard Deviation 10.9232 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 24 | 0.564 g/L | Standard Deviation 8.1879 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 28 | 2.179 g/L | Standard Deviation 10.3285 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 44 | 1.486 g/L | Standard Deviation 10.104 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 16 | -1.619 g/L | Standard Deviation 6.4768 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 32 | 6.308 g/L | Standard Deviation 9.7796 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -3.927 g/L | Standard Deviation 10.0633 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 20 | -0.400 g/L | Standard Deviation 7.3233 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 36 | 5.500 g/L | Standard Deviation 9.7779 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | -5.220 g/L | Standard Deviation 6.7879 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 0.308 g/L | Standard Deviation 7.0865 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 48 | 5.270 g/L | Standard Deviation 9.1974 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 28 | 3.342 g/L | Standard Deviation 8.9511 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | 0.895 g/L | Standard Deviation 7.6434 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 20 | 2.667 g/L | Standard Deviation 8.6764 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 44 | 7.289 g/L | Standard Deviation 12.6254 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 40 | 5.868 g/L | Standard Deviation 8.7863 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 20 | 0.923 g/L | Standard Deviation 11.8108 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -0.359 g/L | Standard Deviation 5.2339 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 0.789 g/L | Standard Deviation 8.9719 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 48 | 7.216 g/L | Standard Deviation 9.3812 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 36 | 10.921 g/L | Standard Deviation 10.2229 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 24 | 3.658 g/L | Standard Deviation 9.0622 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | 0.000 g/L | Standard Deviation 5.6569 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 32 | 10.231 g/L | Standard Deviation 9.5957 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 24 | 4.132 g/L | Standard Deviation 10.3849 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -1.897 g/L | Standard Deviation 11.3249 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 44 | 5.000 g/L | Standard Deviation 9.2998 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | 1.474 g/L | Standard Deviation 10.5849 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 36 | 6.053 g/L | Standard Deviation 8.1405 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 16 | 2.579 g/L | Standard Deviation 8.388 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -3.179 g/L | Standard Deviation 13.4122 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 40 | 8.237 g/L | Standard Deviation 12.0706 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 28 | 4.658 g/L | Standard Deviation 9.6906 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 32 | 4.487 g/L | Standard Deviation 8.3094 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 0.692 g/L | Standard Deviation 7.7601 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 16 | -3.000 g/L | Standard Deviation 14.5751 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 2.564 g/L | Standard Deviation 9.8216 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 36 | 4.293 g/L | Standard Deviation 9.5766 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | -1.860 g/L | Standard Deviation 8.0551 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 0.465 g/L | Standard Deviation 8.4778 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -2.500 g/L | Standard Deviation 11.5045 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -3.780 g/L | Standard Deviation 10.7576 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -3.907 g/L | Standard Deviation 11.5404 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 16 | -5.262 g/L | Standard Deviation 12.1917 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 20 | -1.902 g/L | Standard Deviation 12.8078 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 24 | -0.625 g/L | Standard Deviation 14.6685 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 28 | 1.707 g/L | Standard Deviation 9.9505 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 32 | 4.850 g/L | Standard Deviation 11.3692 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 36 | 2.732 g/L | Standard Deviation 12.4097 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 40 | 4.976 g/L | Standard Deviation 11.5639 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 44 | 3.415 g/L | Standard Deviation 12.6293 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 48 | 2.122 g/L | Standard Deviation 11.8769 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | 1.302 g/L | Standard Deviation 5.148 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | 0.070 g/L | Standard Deviation 6.5915 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | 0.881 g/L | Standard Deviation 6.4551 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 2.195 g/L | Standard Deviation 7.7628 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 2.488 g/L | Standard Deviation 7.6512 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 16 | 1.524 g/L | Standard Deviation 8.7853 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 20 | 2.268 g/L | Standard Deviation 6.9822 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 24 | 4.075 g/L | Standard Deviation 8.0714 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 28 | 3.122 g/L | Standard Deviation 8.6261 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 32 | 4.300 g/L | Standard Deviation 9.4032 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 40 | 4.317 g/L | Standard Deviation 9.6552 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 44 | 3.659 g/L | Standard Deviation 9.175 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 48 | 3.780 g/L | Standard Deviation 9.921 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 32 | 7.971 g/L | Standard Deviation 12.3497 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 28 | 0.857 g/L | Standard Deviation 7.2645 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 0.553 g/L | Standard Deviation 6.801 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 16 | -1.026 g/L | Standard Deviation 11.6816 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 44 | 4.912 g/L | Standard Deviation 8.5895 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 0.927 g/L | Standard Deviation 9.1088 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 32 | 2.118 g/L | Standard Deviation 7.4254 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 28 | 4.400 g/L | Standard Deviation 13.7524 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -2.684 g/L | Standard Deviation 9.4099 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 0.707 g/L | Standard Deviation 8.6263 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -3.079 g/L | Standard Deviation 10.7033 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 36 | 3.818 g/L | Standard Deviation 7.3334 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 20 | 1.892 g/L | Standard Deviation 7.6186 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 0.868 g/L | Standard Deviation 7.3344 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -0.878 g/L | Standard Deviation 9.4026 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 24 | 4.583 g/L | Standard Deviation 11.3121 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 40 | 9.088 g/L | Standard Deviation 11.548 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | 0.512 g/L | Standard Deviation 6.0462 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 48 | 4.030 g/L | Standard Deviation 9.255 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 48 | 5.394 g/L | Standard Deviation 12.93 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 24 | 2.000 g/L | Standard Deviation 6.6462 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 40 | 3.618 g/L | Standard Deviation 7.8277 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -1.561 g/L | Standard Deviation 6.7047 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 16 | 1.737 g/L | Standard Deviation 7.3547 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 44 | 6.353 g/L | Standard Deviation 14.3038 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 20 | 0.919 g/L | Standard Deviation 8.7349 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 36 | 6.788 g/L | Standard Deviation 12.2034 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | 0.512 g/L | Standard Deviation 5.7189 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 44 | 9.278 g/L | Standard Deviation 12.8076 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 36 | 9.462 g/L | Standard Deviation 12.7998 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 2.854 g/L | Standard Deviation 10.1822 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 1.195 g/L | Standard Deviation 7.4439 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 32 | 10.462 g/L | Standard Deviation 12.9855 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 2.488 g/L | Standard Deviation 8.2344 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 16 | 3.125 g/L | Standard Deviation 7.74 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 28 | 6.150 g/L | Standard Deviation 12.5382 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 24 | 4.250 g/L | Standard Deviation 13.4064 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 20 | 2.925 g/L | Standard Deviation 7.7207 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 20 | 0.200 g/L | Standard Deviation 16.1725 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 44 | 4.722 g/L | Standard Deviation 8.5511 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 24 | 3.425 g/L | Standard Deviation 6.2834 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 16 | -0.700 g/L | Standard Deviation 16.1026 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 1.200 g/L | Standard Deviation 12.2395 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 28 | 3.400 g/L | Standard Deviation 8.673 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | 1.732 g/L | Standard Deviation 13.3959 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 32 | 5.615 g/L | Standard Deviation 8.6378 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | 0.610 g/L | Standard Deviation 12.7493 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 36 | 4.949 g/L | Standard Deviation 8.4851 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | 1.756 g/L | Standard Deviation 11.8697 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 48 | 8.250 g/L | Standard Deviation 11.3448 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 48 | 4.725 g/L | Standard Deviation 7.3554 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -0.875 g/L | Standard Deviation 4.8368 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | 1.195 g/L | Standard Deviation 5.8916 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | 0.317 g/L | Standard Deviation 5.3499 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 40 | 9.079 g/L | Standard Deviation 11.5393 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 40 | 4.132 g/L | Standard Deviation 7.7987 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 1 | 0.422 femtolitres (fL) | Standard Deviation 1.8855 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 28 | -0.910 femtolitres (fL) | Standard Deviation 2.6477 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 20 | 0.497 femtolitres (fL) | Standard Deviation 3.5197 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 24 | -1.033 femtolitres (fL) | Standard Deviation 2.9007 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 44 | -1.405 femtolitres (fL) | Standard Deviation 3.4627 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.829 femtolitres (fL) | Standard Deviation 2.3409 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 40 | -1.386 femtolitres (fL) | Standard Deviation 2.8575 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 8 | 1.163 femtolitres (fL) | Standard Deviation 3.6524 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 48 | -0.942 femtolitres (fL) | Standard Deviation 3.5913 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 36 | -1.724 femtolitres (fL) | Standard Deviation 3.1037 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 12 | 1.478 femtolitres (fL) | Standard Deviation 3.956 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 2 | 0.450 femtolitres (fL) | Standard Deviation 1.8867 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 32 | -1.654 femtolitres (fL) | Standard Deviation 2.7565 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 16 | 1.107 femtolitres (fL) | Standard Deviation 3.4022 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 16 | 1.168 femtolitres (fL) | Standard Deviation 3.776 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.951 femtolitres (fL) | Standard Deviation 3.4617 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.938 femtolitres (fL) | Standard Deviation 2.9445 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 20 | -0.349 femtolitres (fL) | Standard Deviation 2.8975 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.362 femtolitres (fL) | Standard Deviation 2.1689 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 24 | -0.858 femtolitres (fL) | Standard Deviation 2.1793 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 28 | -1.184 femtolitres (fL) | Standard Deviation 2.3264 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.087 femtolitres (fL) | Standard Deviation 1.954 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 44 | -1.632 femtolitres (fL) | Standard Deviation 3.4207 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 36 | -2.266 femtolitres (fL) | Standard Deviation 2.3516 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 32 | -1.851 femtolitres (fL) | Standard Deviation 2.4024 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 4 | -0.163 femtolitres (fL) | Standard Deviation 2.4631 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 48 | -1.492 femtolitres (fL) | Standard Deviation 2.5065 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 40 | -1.882 femtolitres (fL) | Standard Deviation 3.1285 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 16 | 1.571 femtolitres (fL) | Standard Deviation 4.3326 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 1 | 0.386 femtolitres (fL) | Standard Deviation 2.2542 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.021 femtolitres (fL) | Standard Deviation 1.8767 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.945 femtolitres (fL) | Standard Deviation 3.2325 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 8 | 1.110 femtolitres (fL) | Standard Deviation 3.0283 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 12 | 1.367 femtolitres (fL) | Standard Deviation 3.8471 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 20 | 0.649 femtolitres (fL) | Standard Deviation 3.7758 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 24 | 0.143 femtolitres (fL) | Standard Deviation 4.9985 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 28 | -0.754 femtolitres (fL) | Standard Deviation 3.3662 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 32 | -1.075 femtolitres (fL) | Standard Deviation 3.539 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 36 | -0.912 femtolitres (fL) | Standard Deviation 3.9627 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 40 | -1.698 femtolitres (fL) | Standard Deviation 3.0263 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 44 | -1.117 femtolitres (fL) | Standard Deviation 3.4616 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 48 | -0.846 femtolitres (fL) | Standard Deviation 3.1243 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 16 | -0.016 femtolitres (fL) | Standard Deviation 3.6944 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 28 | -1.854 femtolitres (fL) | Standard Deviation 3.6605 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.342 femtolitres (fL) | Standard Deviation 3.1129 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 32 | -2.071 femtolitres (fL) | Standard Deviation 3.7652 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.916 femtolitres (fL) | Standard Deviation 3.0058 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.017 femtolitres (fL) | Standard Deviation 2.1066 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 36 | -2.558 femtolitres (fL) | Standard Deviation 3.8468 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.354 femtolitres (fL) | Standard Deviation 2.8851 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 40 | -2.885 femtolitres (fL) | Standard Deviation 3.1443 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.039 femtolitres (fL) | Standard Deviation 2.3876 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 48 | -1.527 femtolitres (fL) | Standard Deviation 3.654 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 20 | -0.338 femtolitres (fL) | Standard Deviation 2.5959 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 44 | -2.171 femtolitres (fL) | Standard Deviation 4.4367 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 24 | -1.522 femtolitres (fL) | Standard Deviation 3.1692 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 20 | 0.202 femtolitres (fL) | Standard Deviation 4.2993 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 48 | -1.788 femtolitres (fL) | Standard Deviation 3.5554 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 28 | -1.638 femtolitres (fL) | Standard Deviation 3.3447 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 12 | -0.390 femtolitres (fL) | Standard Deviation 3.3907 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 24 | -1.195 femtolitres (fL) | Standard Deviation 3.5759 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.510 femtolitres (fL) | Standard Deviation 2.7686 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 40 | -2.421 femtolitres (fL) | Standard Deviation 2.9445 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 32 | -2.351 femtolitres (fL) | Standard Deviation 3.1052 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.090 femtolitres (fL) | Standard Deviation 3.5125 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.549 femtolitres (fL) | Standard Deviation 2.5751 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 16 | 0.048 femtolitres (fL) | Standard Deviation 4.4345 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 44 | -2.186 femtolitres (fL) | Standard Deviation 3.4915 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 36 | -2.236 femtolitres (fL) | Standard Deviation 3.2869 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Week 4 | -0.259 femtolitres (fL) | Standard Deviation 2.5328 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 1 | -0.011 volume % of red blood cells | Standard Deviation 0.0189 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 28 | -0.007 volume % of red blood cells | Standard Deviation 0.021 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 20 | 0.006 volume % of red blood cells | Standard Deviation 0.0217 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 24 | 0.001 volume % of red blood cells | Standard Deviation 0.0192 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 44 | -0.003 volume % of red blood cells | Standard Deviation 0.0272 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 4 | -0.008 volume % of red blood cells | Standard Deviation 0.0254 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 40 | 0.000 volume % of red blood cells | Standard Deviation 0.0231 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 8 | -0.007 volume % of red blood cells | Standard Deviation 0.0239 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 48 | 0.001 volume % of red blood cells | Standard Deviation 0.0243 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 36 | -0.004 volume % of red blood cells | Standard Deviation 0.0222 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 12 | -0.005 volume % of red blood cells | Standard Deviation 0.0287 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 2 | -0.011 volume % of red blood cells | Standard Deviation 0.023 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 32 | -0.009 volume % of red blood cells | Standard Deviation 0.0207 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 16 | 0.004 volume % of red blood cells | Standard Deviation 0.0202 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 16 | 0.012 volume % of red blood cells | Standard Deviation 0.0259 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 12 | 0.007 volume % of red blood cells | Standard Deviation 0.0281 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 8 | 0.003 volume % of red blood cells | Standard Deviation 0.0244 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 20 | 0.007 volume % of red blood cells | Standard Deviation 0.027 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 2 | -0.004 volume % of red blood cells | Standard Deviation 0.0204 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 24 | 0.006 volume % of red blood cells | Standard Deviation 0.0253 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 28 | 0.004 volume % of red blood cells | Standard Deviation 0.0248 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 1 | -0.001 volume % of red blood cells | Standard Deviation 0.0211 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 44 | 0.006 volume % of red blood cells | Standard Deviation 0.0297 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 36 | 0.004 volume % of red blood cells | Standard Deviation 0.0228 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 32 | 0.000 volume % of red blood cells | Standard Deviation 0.0249 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 4 | 0.001 volume % of red blood cells | Standard Deviation 0.0211 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 48 | 0.007 volume % of red blood cells | Standard Deviation 0.0257 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 40 | 0.007 volume % of red blood cells | Standard Deviation 0.0278 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 16 | 0.011 volume % of red blood cells | Standard Deviation 0.0254 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 1 | 0.007 volume % of red blood cells | Standard Deviation 0.0181 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 2 | -0.000 volume % of red blood cells | Standard Deviation 0.0205 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 4 | 0.006 volume % of red blood cells | Standard Deviation 0.022 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 8 | 0.012 volume % of red blood cells | Standard Deviation 0.0237 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 12 | 0.013 volume % of red blood cells | Standard Deviation 0.0276 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 20 | 0.010 volume % of red blood cells | Standard Deviation 0.0211 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 24 | 0.014 volume % of red blood cells | Standard Deviation 0.0256 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 28 | 0.008 volume % of red blood cells | Standard Deviation 0.0241 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 32 | 0.007 volume % of red blood cells | Standard Deviation 0.0225 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 36 | 0.009 volume % of red blood cells | Standard Deviation 0.0258 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 40 | 0.007 volume % of red blood cells | Standard Deviation 0.0246 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 44 | 0.007 volume % of red blood cells | Standard Deviation 0.0239 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 48 | 0.009 volume % of red blood cells | Standard Deviation 0.026 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 16 | 0.006 volume % of red blood cells | Standard Deviation 0.024 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 28 | -0.003 volume % of red blood cells | Standard Deviation 0.0229 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 12 | 0.006 volume % of red blood cells | Standard Deviation 0.0219 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 32 | -0.004 volume % of red blood cells | Standard Deviation 0.0196 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 8 | 0.005 volume % of red blood cells | Standard Deviation 0.0208 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 1 | 0.000 volume % of red blood cells | Standard Deviation 0.0206 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 36 | 0.003 volume % of red blood cells | Standard Deviation 0.0221 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 4 | 0.003 volume % of red blood cells | Standard Deviation 0.019 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 40 | -0.001 volume % of red blood cells | Standard Deviation 0.0221 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 2 | -0.006 volume % of red blood cells | Standard Deviation 0.022 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 48 | 0.005 volume % of red blood cells | Standard Deviation 0.0252 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 20 | 0.004 volume % of red blood cells | Standard Deviation 0.0241 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 44 | 0.007 volume % of red blood cells | Standard Deviation 0.0246 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 24 | -0.000 volume % of red blood cells | Standard Deviation 0.0222 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 20 | 0.008 volume % of red blood cells | Standard Deviation 0.0246 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 48 | 0.004 volume % of red blood cells | Standard Deviation 0.0212 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 28 | 0.002 volume % of red blood cells | Standard Deviation 0.0238 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 12 | 0.005 volume % of red blood cells | Standard Deviation 0.0231 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 24 | 0.005 volume % of red blood cells | Standard Deviation 0.0219 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 1 | -0.004 volume % of red blood cells | Standard Deviation 0.0206 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 40 | 0.000 volume % of red blood cells | Standard Deviation 0.0206 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 32 | 0.003 volume % of red blood cells | Standard Deviation 0.0248 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 8 | 0.003 volume % of red blood cells | Standard Deviation 0.0232 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 2 | -0.003 volume % of red blood cells | Standard Deviation 0.0174 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 16 | 0.010 volume % of red blood cells | Standard Deviation 0.0252 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 44 | 0.002 volume % of red blood cells | Standard Deviation 0.0194 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 36 | 0.003 volume % of red blood cells | Standard Deviation 0.0234 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Week 4 | 0.001 volume % of red blood cells | Standard Deviation 0.0209 |
Secondary
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Platelets was measured in number of platelets per liter (10\^9/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 28 | -24.256 10^9 platelets per liter | Standard Deviation 51.8001 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 8 | 1.561 10^9 platelets per liter | Standard Deviation 29.1042 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 24 | -19.974 10^9 platelets per liter | Standard Deviation 49.0196 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 20 | -18.625 10^9 platelets per liter | Standard Deviation 50.3988 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 4 | -3.927 10^9 platelets per liter | Standard Deviation 29.6643 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 48 | -27.395 10^9 platelets per liter | Standard Deviation 56.2963 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 44 | -22.703 10^9 platelets per liter | Standard Deviation 57.8383 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 1 | -5.073 10^9 platelets per liter | Standard Deviation 30.2609 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 32 | -22.410 10^9 platelets per liter | Standard Deviation 51.9553 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 36 | -25.000 10^9 platelets per liter | Standard Deviation 52.699 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 12 | -2.171 10^9 platelets per liter | Standard Deviation 32.0795 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 40 | -23.432 10^9 platelets per liter | Standard Deviation 53.2747 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 16 | -18.833 10^9 platelets per liter | Standard Deviation 50.4844 |
| Placebo (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 2 | 4.000 10^9 platelets per liter | Standard Deviation 27.3112 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 24 | -14.000 10^9 platelets per liter | Standard Deviation 37.776 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 28 | -16.868 10^9 platelets per liter | Standard Deviation 40.6635 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 32 | -18.590 10^9 platelets per liter | Standard Deviation 41.7226 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 2 | -5.179 10^9 platelets per liter | Standard Deviation 38.28 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 1 | -3.368 10^9 platelets per liter | Standard Deviation 25.9515 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 44 | -22.474 10^9 platelets per liter | Standard Deviation 41.0627 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 4 | -6.868 10^9 platelets per liter | Standard Deviation 29.7487 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 48 | -23.811 10^9 platelets per liter | Standard Deviation 47.115 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 8 | -12.077 10^9 platelets per liter | Standard Deviation 28.9876 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 12 | -17.359 10^9 platelets per liter | Standard Deviation 35.4308 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 16 | -18.263 10^9 platelets per liter | Standard Deviation 37.3259 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 40 | -20.895 10^9 platelets per liter | Standard Deviation 41.4845 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 20 | -23.077 10^9 platelets per liter | Standard Deviation 39.6534 |
| BKZ 16 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 36 | -16.474 10^9 platelets per liter | Standard Deviation 46.8844 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 32 | -13.575 10^9 platelets per liter | Standard Deviation 51.9304 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 20 | -10.512 10^9 platelets per liter | Standard Deviation 48.0755 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 12 | -11.286 10^9 platelets per liter | Standard Deviation 40.7451 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 40 | -14.927 10^9 platelets per liter | Standard Deviation 51.2652 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 16 | -13.952 10^9 platelets per liter | Standard Deviation 50.7173 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 24 | -4.600 10^9 platelets per liter | Standard Deviation 49.4025 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 36 | -14.561 10^9 platelets per liter | Standard Deviation 50.2106 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 28 | -7.683 10^9 platelets per liter | Standard Deviation 47.8155 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 4 | -13.878 10^9 platelets per liter | Standard Deviation 43.7568 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 2 | -3.810 10^9 platelets per liter | Standard Deviation 41.825 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 1 | 3.209 10^9 platelets per liter | Standard Deviation 30.5883 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 8 | -5.475 10^9 platelets per liter | Standard Deviation 44.7718 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 44 | -18.051 10^9 platelets per liter | Standard Deviation 49.1646 |
| BKZ 160 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 48 | -24.220 10^9 platelets per liter | Standard Deviation 46.2458 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 32 | -20.618 10^9 platelets per liter | Standard Deviation 38.8969 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 1 | -2.098 10^9 platelets per liter | Standard Deviation 24.6412 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 40 | -24.088 10^9 platelets per liter | Standard Deviation 33.4133 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 2 | -15.122 10^9 platelets per liter | Standard Deviation 32.8414 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 4 | -19.415 10^9 platelets per liter | Standard Deviation 32.645 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 8 | -17.605 10^9 platelets per liter | Standard Deviation 29.8442 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 12 | -10.079 10^9 platelets per liter | Standard Deviation 44.8977 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 16 | -9.895 10^9 platelets per liter | Standard Deviation 35.3246 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 20 | -15.324 10^9 platelets per liter | Standard Deviation 28.8329 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 24 | -10.972 10^9 platelets per liter | Standard Deviation 36.8375 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 28 | -12.800 10^9 platelets per liter | Standard Deviation 30.7904 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 36 | -18.848 10^9 platelets per liter | Standard Deviation 40.0563 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 44 | -24.735 10^9 platelets per liter | Standard Deviation 38.471 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 48 | -22.273 10^9 platelets per liter | Standard Deviation 37.4243 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 20 | -22.725 10^9 platelets per liter | Standard Deviation 42.2502 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 16 | -25.425 10^9 platelets per liter | Standard Deviation 37.6556 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 12 | -23.171 10^9 platelets per liter | Standard Deviation 47.2995 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 36 | -23.846 10^9 platelets per liter | Standard Deviation 45.134 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 8 | -26.195 10^9 platelets per liter | Standard Deviation 44.1719 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 4 | -27.073 10^9 platelets per liter | Standard Deviation 41.9299 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 2 | -15.415 10^9 platelets per liter | Standard Deviation 31.7025 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 1 | -9.325 10^9 platelets per liter | Standard Deviation 23.4109 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 48 | -28.974 10^9 platelets per liter | Standard Deviation 42.996 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 44 | -31.389 10^9 platelets per liter | Standard Deviation 48.5306 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 40 | -21.789 10^9 platelets per liter | Standard Deviation 46.1467 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 28 | -19.600 10^9 platelets per liter | Standard Deviation 42.3052 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 32 | -23.179 10^9 platelets per liter | Standard Deviation 42.2018 |
| BKZ 320 mg (FAS) | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Week 24 | -22.900 10^9 platelets per liter | Standard Deviation 47.4092 |
Secondary
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 1 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 48 | -27.500 cells/HPF | Standard Deviation 38.8909 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 44 | -55.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 4 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 36 | -55.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 16 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 44 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 32 | -27.500 cells/HPF | Standard Deviation 38.8909 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 28 | -5.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 12 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 1 | -55.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 20 | -30.000 cells/HPF | Standard Deviation 35.3553 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 2 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 1 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 16 | -55.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 44 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 12 | -23.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 32 | 0.500 cells/HPF | Standard Deviation 0.7071 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 28 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 16 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 12 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 4 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 2 | 1.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 44 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 36 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 2 | -54.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 28 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 16 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 1 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 12 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 4 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 2 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 1 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 44 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 20 | 1.000 cells/HPF | Standard Deviation 1.4142 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 36 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 28 | -2.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 20 | 0.000 cells/HPF | Standard Deviation 2.8284 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 28 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 16 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 12 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 4 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 2 | 2.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 4 | 0.000 cells/HPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 1 | 0.750 cells/HPF | Standard Deviation 0.9574 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 2 | -0.500 cells/HPF | Standard Deviation 0.5774 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 4 | 3.333 cells/HPF | Standard Deviation 5.7735 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 20 | -2.750 cells/HPF | Standard Deviation 5.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 40 | -2.750 cells/HPF | Standard Deviation 5.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 8 | 1.000 cells/HPF | Standard Deviation 1.7321 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 16 | 0.400 cells/HPF | Standard Deviation 0.8944 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 16 | 0.800 cells/HPF | Standard Deviation 1.7889 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 24 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 28 | 0.000 cells/HPF | Standard Deviation 0.8165 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 40 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 48 | 0.167 cells/HPF | Standard Deviation 0.4082 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 1 | 2.750 cells/HPF | Standard Deviation 6.1847 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 2 | -2.500 cells/HPF | Standard Deviation 2.0817 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 12 | 1.667 cells/HPF | Standard Deviation 4.7258 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 16 | -0.200 cells/HPF | Standard Deviation 1.7889 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 20 | 3.000 cells/HPF | Standard Deviation 6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 24 | 2.750 cells/HPF | Standard Deviation 4.8563 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 28 | -0.750 cells/HPF | Standard Deviation 0.9574 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 32 | 3.333 cells/HPF | Standard Deviation 5.7735 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 36 | 0.667 cells/HPF | Standard Deviation 2.7325 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 40 | -0.500 cells/HPF | Standard Deviation 2.5166 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 44 | 0.400 cells/HPF | Standard Deviation 0.8944 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 48 | 8.000 cells/HPF | Standard Deviation 21.6148 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 36 | 0.167 cells/HPF | Standard Deviation 0.4082 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 1 | 0.250 cells/HPF | Standard Deviation 1.2583 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 2 | -8.000 cells/HPF | Standard Deviation 14.6969 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 12 | -4.333 cells/HPF | Standard Deviation 7.5056 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 24 | 1.000 cells/HPF | Standard Deviation 1.4142 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 28 | -3.000 cells/HPF | Standard Deviation 6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 44 | -1.000 cells/HPF | Standard Deviation 2.2361 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 48 | 0.667 cells/HPF | Standard Deviation 1.633 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 36 | 0.167 cells/HPF | Standard Deviation 0.4082 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 40 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 1 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 20 | 57.800 cells/HPF | Standard Deviation 145.4036 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 28 | 0.600 cells/HPF | Standard Deviation 1.3416 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 20 | -1.400 cells/HPF | Standard Deviation 5.6391 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 12 | -2.200 cells/HPF | Standard Deviation 5.4955 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 1 | 3.000 cells/HPF | Standard Deviation 5.1962 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 32 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 8 | 0.500 cells/HPF | Standard Deviation 1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 4 | -1.800 cells/HPF | Standard Deviation 7.1554 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 8 | -1.500 cells/HPF | Standard Deviation 3.6968 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 24 | -6.500 cells/HPF | Standard Deviation 13 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 8 | 0.000 cells/HPF | Standard Deviation 0.8165 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 2 | -0.250 cells/HPF | Standard Deviation 3.6856 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 48 | 1.750 cells/HPF | Standard Deviation 3.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 2 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 28 | -5.400 cells/HPF | Standard Deviation 12.0748 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 4 | -4.600 cells/HPF | Standard Deviation 10.2372 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 28 | 0.400 cells/HPF | Standard Deviation 1.5166 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 24 | 1.000 cells/HPF | Standard Deviation 2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 32 | -6.500 cells/HPF | Standard Deviation 13 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 44 | 0.600 cells/HPF | Standard Deviation 1.3416 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 12 | 13.500 cells/HPF | Standard Deviation 26.3376 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 1 | -7.667 cells/HPF | Standard Deviation 13.2791 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 48 | 1.250 cells/HPF | Standard Deviation 1.893 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 24 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 20 | 0.400 cells/HPF | Standard Deviation 1.1402 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 40 | -7.500 cells/HPF | Standard Deviation 15 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 40 | 0.750 cells/HPF | Standard Deviation 1.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 16 | 0.500 cells/HPF | Standard Deviation 1.7321 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 4 | 0.000 cells/HPF | Standard Deviation 0.7071 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 44 | -1.400 cells/HPF | Standard Deviation 3.1305 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 36 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 16 | 33.750 cells/HPF | Standard Deviation 67.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 48 | 69.500 cells/HPF | Standard Deviation 139 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 2 | -3.000 cells/HPF | Standard Deviation 6.6833 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 16 | -2.750 cells/HPF | Standard Deviation 5.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 12 | 0.200 cells/HPF | Standard Deviation 0.4472 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 44 | 0.400 cells/HPF | Standard Deviation 0.8944 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 12 | 0.800 cells/HPF | Standard Deviation 1.3038 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 32 | 0.500 cells/HPF | Standard Deviation 1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 40 | 0.750 cells/HPF | Standard Deviation 1.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 36 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 20 | 0.667 cells/HPF | Standard Deviation 1.5055 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 2 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 4 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 16 | -0.400 cells/HPF | Standard Deviation 0.8944 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 4 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 24 | 2.286 cells/HPF | Standard Deviation 4.8206 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 24 | -0.286 cells/HPF | Standard Deviation 0.488 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 32 | -1.333 cells/HPF | Standard Deviation 1.633 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 20 | -0.167 cells/HPF | Standard Deviation 0.9832 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 36 | 24.000 cells/HPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 40 | 1.500 cells/HPF | Standard Deviation 3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 44 | -0.500 cells/HPF | Standard Deviation 1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 16 | -0.200 cells/HPF | Standard Deviation 0.4472 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 48 | -1.000 cells/HPF | Standard Deviation 1.7321 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 1 | -0.200 cells/HPF | Standard Deviation 0.4472 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 36 | 0.000 cells/HPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 28 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 32 | -0.667 cells/HPF | Standard Deviation 0.8165 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 24 | -0.143 cells/HPF | Standard Deviation 0.8997 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 44 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 36 | 0.000 cells/HPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 40 | -0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 44 | -0.250 cells/HPF | Standard Deviation 1.2583 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 48 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 1 | -0.200 cells/HPF | Standard Deviation 1.0954 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 12 | -0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 28 | -1.667 cells/HPF | Standard Deviation 1.5275 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 1 | -0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 36 | -1.000 cells/HPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 32 | -0.500 cells/HPF | Standard Deviation 0.7071 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 1 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 48 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 48 | 0.000 cells/HPF | Standard Deviation 0.8165 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 36 | 0.000 cells/HPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 24 | 1.333 cells/HPF | Standard Deviation 4.1633 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 4 | 2.000 cells/HPF | Standard Deviation 2.8284 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 4 | -0.500 cells/HPF | Standard Deviation 0.7071 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 40 | -0.500 cells/HPF | Standard Deviation 0.7071 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 8 | 0.000 cells/HPF | Standard Deviation 1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 16 | 2.500 cells/HPF | Standard Deviation 3.5355 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 20 | 0.250 cells/HPF | Standard Deviation 0.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 16 | 0.500 cells/HPF | Standard Deviation 0.7071 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 36 | 0.000 cells/HPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 1 | 0.667 cells/HPF | Standard Deviation 1.1547 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 24 | 1.000 cells/HPF | Standard Deviation 2.6458 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 32 | 1.333 cells/HPF | Standard Deviation 2.3094 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 28 | 2.333 cells/HPF | Standard Deviation 4.0415 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 32 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 36 | 0.000 cells/HPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 2 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 40 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 28 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 28 | 2.333 cells/HPF | Standard Deviation 5.7735 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 24 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 24 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 20 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 2 | -1.667 cells/HPF | Standard Deviation 1.5275 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 1 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 48 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 20 | -6.750 cells/HPF | Standard Deviation 14.8633 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 4 | 1.000 cells/HPF | Standard Deviation 1.4142 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 44 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 12 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Leukocytes Week 8 | 4.000 cells/HPF | Standard Deviation 6.9282 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 8 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 32 | 2.000 cells/HPF | Standard Deviation 3.4641 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes Week 2 | 1.333 cells/HPF | Standard Deviation 2.5166 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 8 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 48 | -1.000 cells/HPF | Standard Deviation 1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 12 | 0.333 cells/HPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Transitional Epithelial Cells Week 16 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Renal Epithelial Casts Week 4 | 0.000 cells/HPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 20 | -0.750 cells/HPF | Standard Deviation 0.9574 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Squamous Epithelial Cells Week 44 | -0.500 cells/HPF | Standard Deviation 0.7071 |
Secondary
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Hyaline casts was measured in cells per low power field (cells/LPF).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 28 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 2 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 16 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 12 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 1 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 32 | 0.000 cells/LPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 4 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 20 | 0.000 cells/LPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 44 | 0.000 cells/LPF | — |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 48 | 0.000 cells/LPF | Standard Deviation 0 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 36 | 0.000 cells/LPF | — |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 16 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 4 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 20 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 48 | 1.167 cells/LPF | Standard Deviation 2.8577 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 24 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 44 | 0.400 cells/LPF | Standard Deviation 0.8944 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 28 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 2 | 0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 40 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 8 | 0.333 cells/LPF | Standard Deviation 0.5774 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 12 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 1 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 36 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 32 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 2 | 1.000 cells/LPF | Standard Deviation 1.1547 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 1 | 1.000 cells/LPF | Standard Deviation 1.7321 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 12 | 5.000 cells/LPF | Standard Deviation 11.1803 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 16 | 0.500 cells/LPF | Standard Deviation 1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 20 | -0.600 cells/LPF | Standard Deviation 0.8944 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 24 | -0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 28 | -0.400 cells/LPF | Standard Deviation 0.8944 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 32 | 1.250 cells/LPF | Standard Deviation 2.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 48 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 4 | -0.800 cells/LPF | Standard Deviation 1.0954 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 8 | 0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 36 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 40 | -0.500 cells/LPF | Standard Deviation 1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 44 | -0.400 cells/LPF | Standard Deviation 0.8944 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 12 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 44 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 36 | 0.000 cells/LPF | — |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 4 | -0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 2 | -0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 48 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 1 | -0.200 cells/LPF | Standard Deviation 0.4472 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 40 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 28 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 8 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 24 | 0.857 cells/LPF | Standard Deviation 2.2678 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 16 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 32 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 20 | 1.500 cells/LPF | Standard Deviation 3.6742 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 32 | 13.333 cells/LPF | Standard Deviation 23.094 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 2 | 0.333 cells/LPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 48 | -0.250 cells/LPF | Standard Deviation 0.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 16 | 0.500 cells/LPF | Standard Deviation 0.7071 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 1 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 4 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 8 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 12 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 36 | 0.000 cells/LPF | — |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 44 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 24 | 0.333 cells/LPF | Standard Deviation 0.5774 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 28 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 40 | 0.000 cells/LPF | Standard Deviation 0 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Week 20 | -0.750 cells/LPF | Standard Deviation 1.5 |
Secondary
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Urine pH was measured on a pH scale.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 2 | -0.155 pH | Standard Deviation 0.9072 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 36 | -0.211 pH | Standard Deviation 0.8353 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 28 | -0.090 pH | Standard Deviation 0.8419 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 32 | -0.218 pH | Standard Deviation 0.8335 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 20 | -0.113 pH | Standard Deviation 0.7884 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 4 | -0.195 pH | Standard Deviation 0.9211 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 1 | -0.138 pH | Standard Deviation 0.9198 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 16 | -0.107 pH | Standard Deviation 0.8449 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 8 | 0.000 pH | Standard Deviation 0.7826 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 44 | -0.458 pH | Standard Deviation 0.778 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 12 | -0.100 pH | Standard Deviation 1.0203 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 48 | -0.092 pH | Standard Deviation 1.0771 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 40 | -0.216 pH | Standard Deviation 0.9394 |
| Placebo (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 24 | -0.154 pH | Standard Deviation 0.94 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 12 | 0.237 pH | Standard Deviation 0.76 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 36 | 0.118 pH | Standard Deviation 0.73 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 8 | 0.077 pH | Standard Deviation 0.7393 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 28 | -0.053 pH | Standard Deviation 0.6657 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 2 | 0.154 pH | Standard Deviation 0.7708 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 32 | -0.079 pH | Standard Deviation 0.7491 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 48 | -0.014 pH | Standard Deviation 0.7318 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 1 | 0.197 pH | Standard Deviation 0.5875 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 20 | 0.269 pH | Standard Deviation 0.8649 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 44 | -0.171 pH | Standard Deviation 0.7002 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 40 | -0.041 pH | Standard Deviation 0.6388 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 4 | 0.026 pH | Standard Deviation 0.6571 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 24 | -0.013 pH | Standard Deviation 0.8011 |
| BKZ 16 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 16 | 0.092 pH | Standard Deviation 0.7957 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 1 | 0.023 pH | Standard Deviation 0.8014 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 2 | -0.081 pH | Standard Deviation 0.7149 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 4 | -0.134 pH | Standard Deviation 0.8368 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 8 | -0.024 pH | Standard Deviation 0.8762 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 20 | -0.012 pH | Standard Deviation 0.83 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 24 | -0.085 pH | Standard Deviation 0.6605 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 28 | -0.122 pH | Standard Deviation 0.7313 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 32 | 0.063 pH | Standard Deviation 0.8784 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 36 | -0.195 pH | Standard Deviation 0.8506 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 40 | -0.188 pH | Standard Deviation 0.8525 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 48 | -0.200 pH | Standard Deviation 0.8533 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 12 | -0.047 pH | Standard Deviation 0.6971 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 16 | -0.122 pH | Standard Deviation 0.8199 |
| BKZ 160 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 44 | -0.159 pH | Standard Deviation 0.9044 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 24 | 0.100 pH | Standard Deviation 0.482 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 36 | -0.118 pH | Standard Deviation 0.6038 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 20 | -0.054 pH | Standard Deviation 0.6539 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 1 | 0.085 pH | Standard Deviation 0.6011 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 40 | -0.191 pH | Standard Deviation 0.5643 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 8 | 0.263 pH | Standard Deviation 0.7235 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 44 | -0.167 pH | Standard Deviation 0.6693 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 48 | -0.015 pH | Standard Deviation 0.7855 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 12 | 0.211 pH | Standard Deviation 0.6641 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 4 | 0.063 pH | Standard Deviation 0.662 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 16 | 0.118 pH | Standard Deviation 0.7207 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 28 | 0.086 pH | Standard Deviation 0.6122 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 32 | -0.103 pH | Standard Deviation 0.6717 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 2 | 0.134 pH | Standard Deviation 0.8293 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 32 | -0.269 pH | Standard Deviation 0.5718 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 12 | 0.073 pH | Standard Deviation 0.8843 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 36 | -0.077 pH | Standard Deviation 0.7569 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 20 | 0.063 pH | Standard Deviation 0.8929 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 4 | -0.098 pH | Standard Deviation 0.6729 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 2 | -0.012 pH | Standard Deviation 0.7541 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 1 | 0.000 pH | Standard Deviation 0.8321 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 40 | -0.154 pH | Standard Deviation 0.7448 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 8 | 0.024 pH | Standard Deviation 0.7579 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 24 | -0.026 pH | Standard Deviation 0.6973 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 16 | 0.088 pH | Standard Deviation 0.724 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 28 | -0.088 pH | Standard Deviation 0.6783 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 48 | -0.100 pH | Standard Deviation 0.7528 |
| BKZ 320 mg (FAS) | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Week 44 | -0.171 pH | Standard Deviation 0.7285 |
Secondary
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Time frame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 post dose | -2.3 mmHg | Standard Deviation 11.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 pre-dose | -3.1 mmHg | Standard Deviation 10.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 pre-dose | -0.4 mmHg | Standard Deviation 7.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 post dose | -3.0 mmHg | Standard Deviation 9.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 pre-dose | 1.0 mmHg | Standard Deviation 8.2 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 pre-dose | -0.1 mmHg | Standard Deviation 11.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 post dose | 0.1 mmHg | Standard Deviation 9.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 post dose | 0.7 mmHg | Standard Deviation 10 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 48 | -1.1 mmHg | Standard Deviation 14 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 2 | -0.7 mmHg | Standard Deviation 12.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 pre-dose | -0.9 mmHg | Standard Deviation 13.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 post dose | -3.7 mmHg | Standard Deviation 17.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 post dose | -2.0 mmHg | Standard Deviation 8.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 pre-dose | -3.3 mmHg | Standard Deviation 12.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 30 min post dose | 1.3 mmHg | Standard Deviation 8.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 post dose | -3.5 mmHg | Standard Deviation 12.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 pre-dose | -3.1 mmHg | Standard Deviation 11.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 post dose | 1.2 mmHg | Standard Deviation 8.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 pre-dose | 0.8 mmHg | Standard Deviation 7.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 1 h post dose | 1.1 mmHg | Standard Deviation 8.8 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 post dose | -1.1 mmHg | Standard Deviation 12.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 pre-dose | 0.0 mmHg | Standard Deviation 8.2 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 pre-dose | 0.2 mmHg | Standard Deviation 8.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 post dose | -0.6 mmHg | Standard Deviation 11.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.1 mmHg | Standard Deviation 9.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 1 | -1.7 mmHg | Standard Deviation 10.8 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 2 | 0.7 mmHg | Standard Deviation 10.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 pre-dose | 0.5 mmHg | Standard Deviation 10.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 pre-dose | -2.1 mmHg | Standard Deviation 13.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 post dose | -1.8 mmHg | Standard Deviation 14.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 post dose | 2.3 mmHg | Standard Deviation 9.2 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 pre-dose | -2.7 mmHg | Standard Deviation 9.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 post dose | -0.3 mmHg | Standard Deviation 9.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 post dose | -3.2 mmHg | Standard Deviation 12.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 1 hour post dose | -0.6 mmHg | Standard Deviation 9.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 pre-dose | 0.2 mmHg | Standard Deviation 9.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 pre-dose | -2.0 mmHg | Standard Deviation 13.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 post dose | -1.7 mmHg | Standard Deviation 12.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 48 | 1.8 mmHg | Standard Deviation 9.2 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 pre-dose | 1.4 mmHg | Standard Deviation 9.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 post dose | -3.9 mmHg | Standard Deviation 14.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 pre-dose | -2.6 mmHg | Standard Deviation 11.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 pre-dose | 0.0 mmHg | Standard Deviation 8.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 pre-dose | -2.8 mmHg | Standard Deviation 12.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 pre-dose | -3.3 mmHg | Standard Deviation 12.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 post dose | -2.6 mmHg | Standard Deviation 10.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 pre-dose | 1.4 mmHg | Standard Deviation 7.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 post dose | 1.6 mmHg | Standard Deviation 7.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 pre-dose | -3.6 mmHg | Standard Deviation 15.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 post dose | -1.9 mmHg | Standard Deviation 14.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 post dose | -0.9 mmHg | Standard Deviation 9.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 30 min post dose | 0.8 mmHg | Standard Deviation 8.1 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 post dose | -0.6 mmHg | Standard Deviation 7.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 post dose | 0.9 mmHg | Standard Deviation 7.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 post dose | -3.0 mmHg | Standard Deviation 8.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 post dose | -1.8 mmHg | Standard Deviation 9.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 pre-dose | -2.1 mmHg | Standard Deviation 7.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 1 | -1.3 mmHg | Standard Deviation 10 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 pre-dose | -3.2 mmHg | Standard Deviation 12.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 48 | 0.4 mmHg | Standard Deviation 9.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 post dose | -2.6 mmHg | Standard Deviation 11.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 post dose | -0.6 mmHg | Standard Deviation 10.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 2 | -0.2 mmHg | Standard Deviation 9.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 pre-dose | -0.8 mmHg | Standard Deviation 10.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 post dose | -1.9 mmHg | Standard Deviation 11.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 48 | -0.1 mmHg | Standard Deviation 12.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 pre-dose | -2.8 mmHg | Standard Deviation 9.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 post dose | 2.1 mmHg | Standard Deviation 11.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 pre-dose | -1.5 mmHg | Standard Deviation 10.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 pre-dose | 1.6 mmHg | Standard Deviation 13.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 pre-dose | -2.3 mmHg | Standard Deviation 12.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 pre-dose | -0.6 mmHg | Standard Deviation 9.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 post dose | -0.4 mmHg | Standard Deviation 12.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 pre-dose | -1.1 mmHg | Standard Deviation 9.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 pre-dose | -2.5 mmHg | Standard Deviation 12.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 pre-dose | -3.1 mmHg | Standard Deviation 11.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 pre-dose | -1.5 mmHg | Standard Deviation 13.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 30 min post dose | -1.2 mmHg | Standard Deviation 4.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 post dose | 1.3 mmHg | Standard Deviation 12.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 1 h post dose | -2.0 mmHg | Standard Deviation 6.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 1 | -0.3 mmHg | Standard Deviation 6.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 pre-dose | -1.7 mmHg | Standard Deviation 8.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 2 | -0.7 mmHg | Standard Deviation 6.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 pre-dose | 1.1 mmHg | Standard Deviation 13.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 pre-dose | -1.7 mmHg | Standard Deviation 8.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 post dose | -1.0 mmHg | Standard Deviation 7.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 pre-dose | -1.3 mmHg | Standard Deviation 8.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 post dose | -2.2 mmHg | Standard Deviation 11.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 post dose | -1.1 mmHg | Standard Deviation 8.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 pre-dose | -1.1 mmHg | Standard Deviation 10.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 post dose | -1.6 mmHg | Standard Deviation 9.2 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 post dose | -2.0 mmHg | Standard Deviation 10 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 pre-dose | -3.5 mmHg | Standard Deviation 8.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 post dose | -2.9 mmHg | Standard Deviation 11.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 pre-dose | -1.8 mmHg | Standard Deviation 9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 post dose | -1.3 mmHg | Standard Deviation 7.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 post dose | -3.1 mmHg | Standard Deviation 8.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 pre-dose | -1.6 mmHg | Standard Deviation 7.2 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 30 min post dose | 0.5 mmHg | Standard Deviation 9.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 post dose | -2.8 mmHg | Standard Deviation 10.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 post dose | -1.7 mmHg | Standard Deviation 7.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 post dose | -2.0 mmHg | Standard Deviation 9.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 post dose | -1.9 mmHg | Standard Deviation 8.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 post dose | -1.2 mmHg | Standard Deviation 9.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 pre-dose | -0.6 mmHg | Standard Deviation 9.2 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 1 hour post dose | -2.0 mmHg | Standard Deviation 10.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 post dose | -3.2 mmHg | Standard Deviation 13 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 pre-dose | -2.5 mmHg | Standard Deviation 9.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 post dose | -0.3 mmHg | Standard Deviation 11.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 post dose | 1.2 mmHg | Standard Deviation 9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 pre-dose | 0.2 mmHg | Standard Deviation 8.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 30 min post dose | -0.8 mmHg | Standard Deviation 8.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 pre-dose | -0.6 mmHg | Standard Deviation 12.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 post dose | -1.9 mmHg | Standard Deviation 12 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 48 | -0.1 mmHg | Standard Deviation 12.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 post dose | 0.3 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 post dose | 1.3 mmHg | Standard Deviation 9.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 post dose | -2.6 mmHg | Standard Deviation 12.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 2 | -0.1 mmHg | Standard Deviation 13.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 pre-dose | -2.6 mmHg | Standard Deviation 11.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 pre-dose | -0.8 mmHg | Standard Deviation 8.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 post dose | -1.7 mmHg | Standard Deviation 9.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 pre-dose | -1.1 mmHg | Standard Deviation 11.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 post dose | 0.1 mmHg | Standard Deviation 9.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 pre-dose | -4.3 mmHg | Standard Deviation 11.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 pre-dose | 1.3 mmHg | Standard Deviation 9.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 pre-dose | -0.6 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 pre-dose | -2.7 mmHg | Standard Deviation 12.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 post dose | -2.2 mmHg | Standard Deviation 11.8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 pre-dose | -1.0 mmHg | Standard Deviation 13 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 48 | 1.1 mmHg | Standard Deviation 9.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 post dose | -0.4 mmHg | Standard Deviation 9.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 post dose | -0.7 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 post dose | -2.2 mmHg | Standard Deviation 11.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 pre-dose | 0.0 mmHg | Standard Deviation 13.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 post dose | 0.2 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 pre-dose | -0.2 mmHg | Standard Deviation 13.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.6 mmHg | Standard Deviation 11.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 pre-dose | -0.7 mmHg | Standard Deviation 9.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 2 | -1.0 mmHg | Standard Deviation 8.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 pre-dose | 1.6 mmHg | Standard Deviation 9.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 pre-dose | 1.4 mmHg | Standard Deviation 8.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 1 h post dose | -0.7 mmHg | Standard Deviation 8.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 1 | 1.7 mmHg | Standard Deviation 12.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 pre-dose | -1.4 mmHg | Standard Deviation 10.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 post dose | -0.6 mmHg | Standard Deviation 10.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 30 min post dose | -1.2 mmHg | Standard Deviation 5.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 post dose | -0.5 mmHg | Standard Deviation 12.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 1 hour post dose | 0.2 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 post dose | -1.2 mmHg | Standard Deviation 8.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 pre-dose | -2.5 mmHg | Standard Deviation 13.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 post dose | 0.3 mmHg | Standard Deviation 12.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 pre-dose | -1.6 mmHg | Standard Deviation 12.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 post dose | -3.7 mmHg | Standard Deviation 12.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 pre-dose | 0.3 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 pre-dose | 0.9 mmHg | Standard Deviation 9.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 post dose | -0.3 mmHg | Standard Deviation 8.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 post dose | -3.4 mmHg | Standard Deviation 12.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 pre-dose | 1.0 mmHg | Standard Deviation 9.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 post dose | 0.6 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 post dose | -1.2 mmHg | Standard Deviation 13.8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 pre-dose | -3.1 mmHg | Standard Deviation 11.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 pre-dose | -1.2 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 post dose | -0.3 mmHg | Standard Deviation 7.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 pre-dose | -0.6 mmHg | Standard Deviation 6.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 30 min post dose | 1.5 mmHg | Standard Deviation 8.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 1 | -2.4 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 2 | -2.7 mmHg | Standard Deviation 8.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 post dose | -3.6 mmHg | Standard Deviation 10.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 post dose | -2.7 mmHg | Standard Deviation 11 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 post dose | -7.9 mmHg | Standard Deviation 11.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 post dose | -3.0 mmHg | Standard Deviation 9.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 pre-dose | 0.4 mmHg | Standard Deviation 11.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 30 min post dose | 0.6 mmHg | Standard Deviation 6.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 1 h post dose | 1.2 mmHg | Standard Deviation 6.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 1 | -0.9 mmHg | Standard Deviation 6.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 2 | -2.7 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 pre-dose | -0.8 mmHg | Standard Deviation 7.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 post dose | -0.9 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 pre-dose | -0.5 mmHg | Standard Deviation 7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 post dose | -0.7 mmHg | Standard Deviation 7.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 pre-dose | -1.5 mmHg | Standard Deviation 7.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 post dose | -1.8 mmHg | Standard Deviation 7.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 post dose | -1.1 mmHg | Standard Deviation 7.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 pre-dose | -1.4 mmHg | Standard Deviation 8.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 post dose | -3.0 mmHg | Standard Deviation 9.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 pre-dose | 1.0 mmHg | Standard Deviation 6.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 post dose | -0.2 mmHg | Standard Deviation 7.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 pre-dose | -0.3 mmHg | Standard Deviation 9.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 post dose | -0.6 mmHg | Standard Deviation 8.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 pre-dose | -0.9 mmHg | Standard Deviation 7.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 post dose | -1.7 mmHg | Standard Deviation 6.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 pre-dose | -1.0 mmHg | Standard Deviation 7.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 post dose | -0.8 mmHg | Standard Deviation 6.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 pre-dose | -0.4 mmHg | Standard Deviation 6.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 post dose | -1.4 mmHg | Standard Deviation 8.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 48 | 0.6 mmHg | Standard Deviation 8.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 1 hour post dose | 1.0 mmHg | Standard Deviation 8.4 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 pre-dose | -2.3 mmHg | Standard Deviation 10.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 post dose | -0.6 mmHg | Standard Deviation 9.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 pre-dose | -3.6 mmHg | Standard Deviation 11.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 post dose | -2.8 mmHg | Standard Deviation 10.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 pre-dose | -4.4 mmHg | Standard Deviation 10.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 pre-dose | -4.3 mmHg | Standard Deviation 12.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 pre-dose | -5.4 mmHg | Standard Deviation 9.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 pre-dose | -3.6 mmHg | Standard Deviation 10.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 post dose | -0.7 mmHg | Standard Deviation 11.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 pre-dose | 0.6 mmHg | Standard Deviation 11 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 post dose | -0.4 mmHg | Standard Deviation 11.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 pre-dose | -1.8 mmHg | Standard Deviation 11.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 post dose | -3.8 mmHg | Standard Deviation 10.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 pre-dose | -4.0 mmHg | Standard Deviation 9.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 post dose | -3.2 mmHg | Standard Deviation 11.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 pre-dose | -5.1 mmHg | Standard Deviation 9.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 post dose | -4.6 mmHg | Standard Deviation 10.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 48 | -2.8 mmHg | Standard Deviation 11.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 post dose | -0.1 mmHg | Standard Deviation 7.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 36 pre-dose | 0.8 mmHg | Standard Deviation 7.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 post dose | -2.1 mmHg | Standard Deviation 8.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 pre-dose | -3.9 mmHg | Standard Deviation 10.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 pre-dose | -0.3 mmHg | Standard Deviation 10.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 post dose | -1.8 mmHg | Standard Deviation 7.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 pre-dose | -1.0 mmHg | Standard Deviation 6.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 post dose | -2.6 mmHg | Standard Deviation 7.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 20 pre-dose | -1.8 mmHg | Standard Deviation 7.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 post dose | -2.4 mmHg | Standard Deviation 8.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 post dose | -2.6 mmHg | Standard Deviation 8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 1 hour post dose | -1.8 mmHg | Standard Deviation 7.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 post dose | -4.6 mmHg | Standard Deviation 11.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 12 pre-dose | -0.6 mmHg | Standard Deviation 8.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure 30 min post dose | -2.5 mmHg | Standard Deviation 9.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 pre-dose | -3.7 mmHg | Standard Deviation 12.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 post dose | -2.2 mmHg | Standard Deviation 7.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 8 pre-dose | 0.2 mmHg | Standard Deviation 6.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 post dose | -1.6 mmHg | Standard Deviation 7.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 32 pre-dose | -1.2 mmHg | Standard Deviation 8.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 32 post dose | -4.8 mmHg | Standard Deviation 10.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 4 pre-dose | -1.3 mmHg | Standard Deviation 7.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 2 | -0.1 mmHg | Standard Deviation 9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 1 | -0.4 mmHg | Standard Deviation 6.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 48 | -5.2 mmHg | Standard Deviation 9.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 pre-dose | -3.2 mmHg | Standard Deviation 11.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 1 h post dose | -1.0 mmHg | Standard Deviation 5.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure 30 min post dose | -0.6 mmHg | Standard Deviation 5.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 36 post dose | -3.8 mmHg | Standard Deviation 11.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 44 post dose | -3.8 mmHg | Standard Deviation 10.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 28 pre-dose | -2.9 mmHg | Standard Deviation 11.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 24 post dose | -1.1 mmHg | Standard Deviation 10.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 28 pre-dose | -0.5 mmHg | Standard Deviation 7.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 pre-dose | -1.2 mmHg | Standard Deviation 11 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 post dose | -4.4 mmHg | Standard Deviation 9.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 post dose | -5.7 mmHg | Standard Deviation 8.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 post dose | -2.4 mmHg | Standard Deviation 10.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 24 post dose | -1.4 mmHg | Standard Deviation 7.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 40 post dose | -2.2 mmHg | Standard Deviation 9.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 post dose | -1.9 mmHg | Standard Deviation 12 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 2 | -0.4 mmHg | Standard Deviation 11.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 12 pre-dose | -2.6 mmHg | Standard Deviation 9.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 8 pre-dose | -1.3 mmHg | Standard Deviation 10.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 post dose | -3.7 mmHg | Standard Deviation 11.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 1 | -1.6 mmHg | Standard Deviation 11 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 16 pre-dose | -2.3 mmHg | Standard Deviation 11.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 4 pre-dose | -2.7 mmHg | Standard Deviation 11.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 48 | -0.8 mmHg | Standard Deviation 6.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 post dose | -1.5 mmHg | Standard Deviation 6.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 44 pre-dose | -2.4 mmHg | Standard Deviation 10.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 post dose | -0.1 mmHg | Standard Deviation 7.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 16 pre-dose | -0.4 mmHg | Standard Deviation 7.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Systolic Blood Pressure Week 20 pre-dose | -4.5 mmHg | Standard Deviation 10.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic Blood Pressure Week 40 pre-dose | -1.9 mmHg | Standard Deviation 6.8 |
Secondary
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Time frame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 1 | 2.9 beats/min | Standard Deviation 8.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 post dose | 2.9 beats/min | Standard Deviation 6.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 post dose | -0.1 beats/min | Standard Deviation 6.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 pre-dose | 0.9 beats/min | Standard Deviation 6.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 post dose | 0.4 beats/min | Standard Deviation 8.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 2 | 1.2 beats/min | Standard Deviation 6.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 post dose | 0.9 beats/min | Standard Deviation 8.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 pre-dose | -0.2 beats/min | Standard Deviation 5.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 pre-dose | 2.7 beats/min | Standard Deviation 10.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 pre-dose | 0.7 beats/min | Standard Deviation 8.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 post dose | 1.1 beats/min | Standard Deviation 7.6 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 pre-dose | 2.2 beats/min | Standard Deviation 8.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 pre-dose | -0.2 beats/min | Standard Deviation 8.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 post dose | 3.3 beats/min | Standard Deviation 8.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 pre-dose | 3.3 beats/min | Standard Deviation 10 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 post dose | 1.8 beats/min | Standard Deviation 7.5 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 pre-dose | 1.9 beats/min | Standard Deviation 9.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 30 min post dose | 0.4 beats/min | Standard Deviation 5.4 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 post dose | -0.6 beats/min | Standard Deviation 8.8 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 post dose | -0.9 beats/min | Standard Deviation 7.8 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 pre-dose | -0.5 beats/min | Standard Deviation 7.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 post dose | -0.7 beats/min | Standard Deviation 6.8 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 1 hour post dose | 0.3 beats/min | Standard Deviation 6.7 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 48 | 2.0 beats/min | Standard Deviation 8.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 pre-dose | -0.1 beats/min | Standard Deviation 10.3 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 post dose | -0.1 beats/min | Standard Deviation 9.9 |
| Placebo (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 pre-dose | 1.1 beats/min | Standard Deviation 10.2 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 48 | -3.7 beats/min | Standard Deviation 7.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 post dose | -3.3 beats/min | Standard Deviation 8.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 pre-dose | -2.1 beats/min | Standard Deviation 5.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 pre-dose | -1.6 beats/min | Standard Deviation 6.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 30 min post dose | -0.8 beats/min | Standard Deviation 5.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 1 hour post dose | 1.0 beats/min | Standard Deviation 11.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 1 | -1.5 beats/min | Standard Deviation 7.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 2 | -1.7 beats/min | Standard Deviation 5.7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 pre-dose | -2.1 beats/min | Standard Deviation 6.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 post dose | -2.6 beats/min | Standard Deviation 6.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 pre-dose | -0.6 beats/min | Standard Deviation 8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 post dose | -1.3 beats/min | Standard Deviation 8.6 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 pre-dose | -2.2 beats/min | Standard Deviation 8.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 post dose | -3.5 beats/min | Standard Deviation 5.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 pre-dose | -2.4 beats/min | Standard Deviation 7 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 post dose | -2.3 beats/min | Standard Deviation 7.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 pre-dose | -2.0 beats/min | Standard Deviation 8.1 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 post dose | -2.9 beats/min | Standard Deviation 8.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 pre-dose | -2.1 beats/min | Standard Deviation 10 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 post dose | -3.0 beats/min | Standard Deviation 9.4 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 pre-dose | -0.9 beats/min | Standard Deviation 7.9 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 post dose | -0.8 beats/min | Standard Deviation 7.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 pre-dose | 0.2 beats/min | Standard Deviation 7.5 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 post dose | -0.8 beats/min | Standard Deviation 8.2 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 pre-dose | -0.5 beats/min | Standard Deviation 8.8 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 post dose | -1.7 beats/min | Standard Deviation 8.3 |
| BKZ 16 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 post dose | -1.7 beats/min | Standard Deviation 8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 pre-dose | -1.9 beats/min | Standard Deviation 8.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 pre-dose | -2.6 beats/min | Standard Deviation 8.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 pre-dose | -1.7 beats/min | Standard Deviation 10.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 post dose | -3.0 beats/min | Standard Deviation 9.8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 2 | -0.7 beats/min | Standard Deviation 7.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 post dose | -0.5 beats/min | Standard Deviation 11 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 pre-dose | -2.9 beats/min | Standard Deviation 8 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 post dose | -2.1 beats/min | Standard Deviation 9.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 post dose | -2.7 beats/min | Standard Deviation 9.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 pre-dose | -2.9 beats/min | Standard Deviation 10.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 pre-dose | -1.6 beats/min | Standard Deviation 8.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 1 | -0.7 beats/min | Standard Deviation 7.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 pre-dose | 1.0 beats/min | Standard Deviation 10.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 post dose | 0.0 beats/min | Standard Deviation 8.9 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 pre-dose | -2.8 beats/min | Standard Deviation 10.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 30 min post dose | -1.5 beats/min | Standard Deviation 7.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 post dose | -3.0 beats/min | Standard Deviation 9.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 post dose | -3.7 beats/min | Standard Deviation 9.7 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 pre-dose | 0.0 beats/min | Standard Deviation 9.3 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 post dose | -0.5 beats/min | Standard Deviation 8.5 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 1 hour post dose | -0.8 beats/min | Standard Deviation 7.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 48 | -2.5 beats/min | Standard Deviation 10.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 pre-dose | -2.0 beats/min | Standard Deviation 9.2 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 post dose | -1.9 beats/min | Standard Deviation 8.6 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 pre-dose | -0.4 beats/min | Standard Deviation 10.1 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 post dose | -3.6 beats/min | Standard Deviation 9.4 |
| BKZ 160 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 post dose | -3.0 beats/min | Standard Deviation 9.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 post dose | -2.1 beats/min | Standard Deviation 9.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 48 | -4.2 beats/min | Standard Deviation 9.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 pre-dose | -2.6 beats/min | Standard Deviation 10.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 post dose | -1.9 beats/min | Standard Deviation 9.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 pre-dose | -0.7 beats/min | Standard Deviation 7.3 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 post dose | -2.8 beats/min | Standard Deviation 7.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 1 hour post dose | -0.8 beats/min | Standard Deviation 8.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 post dose | -2.5 beats/min | Standard Deviation 8.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 2 | -1.0 beats/min | Standard Deviation 9.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 pre-dose | 0.0 beats/min | Standard Deviation 9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 post dose | 0.0 beats/min | Standard Deviation 8.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 post dose | -2.1 beats/min | Standard Deviation 9.7 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 post dose | -2.0 beats/min | Standard Deviation 8.4 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 pre-dose | 0.1 beats/min | Standard Deviation 9.8 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 pre-dose | -1.7 beats/min | Standard Deviation 7.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 pre-dose | -1.2 beats/min | Standard Deviation 10.6 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 post dose | -1.3 beats/min | Standard Deviation 6.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 pre-dose | -1.7 beats/min | Standard Deviation 9.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 post dose | -0.5 beats/min | Standard Deviation 9.4 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 post dose | -0.1 beats/min | Standard Deviation 8.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 1 | 0.6 beats/min | Standard Deviation 8.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 post dose | -0.8 beats/min | Standard Deviation 10 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 pre-dose | -1.4 beats/min | Standard Deviation 8.2 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 pre-dose | 0.8 beats/min | Standard Deviation 6.9 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 30 min post dose | -2.3 beats/min | Standard Deviation 7.5 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 pre-dose | -1.9 beats/min | Standard Deviation 10.1 |
| BKZ 160 mg LD (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 pre-dose | -0.5 beats/min | Standard Deviation 11.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 pre-dose | -0.3 beats/min | Standard Deviation 7.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 post dose | -2.3 beats/min | Standard Deviation 8.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 1 hour post dose | -0.4 beats/min | Standard Deviation 7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 pre-dose | -1.1 beats/min | Standard Deviation 8.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 12 post dose | -2.0 beats/min | Standard Deviation 7.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 pre-dose | -1.3 beats/min | Standard Deviation 7.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 pre-dose | 2.0 beats/min | Standard Deviation 9.4 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 16 post dose | -2.2 beats/min | Standard Deviation 7.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 pre-dose | -1.2 beats/min | Standard Deviation 9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | 30 min post dose | -1.1 beats/min | Standard Deviation 7.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 20 post dose | -1.3 beats/min | Standard Deviation 8.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 pre-dose | -1.2 beats/min | Standard Deviation 7.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 24 post dose | -2.5 beats/min | Standard Deviation 7.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 48 | -3.1 beats/min | Standard Deviation 9.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 pre-dose | 0.2 beats/min | Standard Deviation 8.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 pre-dose | 0.7 beats/min | Standard Deviation 9.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 28 post dose | 0.0 beats/min | Standard Deviation 7.5 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 pre-dose | -0.5 beats/min | Standard Deviation 9.7 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 40 post dose | 0.5 beats/min | Standard Deviation 9.1 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 2 | -0.4 beats/min | Standard Deviation 6.9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 36 post dose | -1.4 beats/min | Standard Deviation 9.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 pre-dose | -1.0 beats/min | Standard Deviation 6.6 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 1 | -0.8 beats/min | Standard Deviation 9 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 32 post dose | -2.0 beats/min | Standard Deviation 8.8 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 4 post dose | -1.1 beats/min | Standard Deviation 6.2 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 44 post dose | -0.2 beats/min | Standard Deviation 10.3 |
| BKZ 320 mg (FAS) | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Week 8 pre-dose | -1.3 beats/min | Standard Deviation 8.2 |
Secondary
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
Population: Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 10.0 percentage of subjects |
| BKZ 16 mg (FAS) | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 57.1 percentage of subjects |
| BKZ 160 mg (FAS) | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 68.8 percentage of subjects |
| BKZ 160 mg LD (FAS) | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 70.6 percentage of subjects |
| BKZ 320 mg (FAS) | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 72.7 percentage of subjects |
Secondary
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
Population: Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 10.0 percentage of subjects |
| BKZ 16 mg (FAS) | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 35.7 percentage of subjects |
| BKZ 160 mg (FAS) | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 62.5 percentage of subjects |
| BKZ 160 mg LD (FAS) | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 52.9 percentage of subjects |
| BKZ 320 mg (FAS) | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 45.5 percentage of subjects |
Secondary
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 4.8 percentage of participants |
| BKZ 16 mg (FAS) | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 0 percentage of participants |
| BKZ 160 mg (FAS) | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 4.8 percentage of participants |
| BKZ 160 mg LD (FAS) | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 2.5 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 57.1 percentage of participants |
| BKZ 16 mg (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 33.33 percentage of participants |
| BKZ 160 mg (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 74.6 percentage of participants |
| BKZ 160 mg LD (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 72.5 percentage of participants |
Secondary
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 2.4 percentage of participants |
| BKZ 16 mg (FAS) | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 0 percentage of participants |
| BKZ 160 mg (FAS) | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 6.3 percentage of participants |
| BKZ 160 mg LD (FAS) | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 0 percentage of participants |