Diabetes Mellitus, Type 2
Conditions
Keywords
NIDDM
Brief summary
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
Detailed description
A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension
Interventions
DRUGPlacebo
Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DRUGDEN 2.5 mg
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DRUGDEN 7.5 mg
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DRUGDEN 15 mg
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DRUGDEN 30 mg
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DRUGDEN 45 mg
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women must not be pregnant and must not be breastfeeding. * Have Type II diabetes. * Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.
Exclusion criteria
* Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (Week 0) and Week 12 | HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FPG at Week 12 | Baseline (Week 0) and Week 12 | The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean. |
| Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Baseline (Week 0) up to Week 24 | The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values. |
| Number of Participants Who Were HbA1c Responders at Week 12 | Week 12 | HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of \<=6.5%, \<7% and HbA1c reduction of \>=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement. |
| Number of Participants of FPG Responders at Week 12 | Week 12 | The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of \<7 mmol/L and FPG reduction value of \>=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement. |
| Change From Baseline in Fructosamine at Week 12 | Baseline (Week 0) and Week 12 | The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean. |
| Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Baseline (Week 0) up to Week 24 | The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values. |
| Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Baseline (Week 0) and Week 12 | The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean. |
| Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Baseline (Week 0) up to Week 24 | The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values. |
| Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Baseline (Week 0) up to Week 24 | The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values. |
| Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | Baseline (Week 0) and Week 12 | The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean. |
| Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Baseline (Week 0) and Week 4 and 8 | The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean. |
| Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Up to Week 25 | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. |
| Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Baseline (Week 0) up to Week 24 | HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values. |
| Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Up to Week 24 | The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized. |
| Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | Baseline (Week 0) up to Week 24 | The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline \>30 beats per minute (bpm) and \<50 or \>120 bpm; SBP increase or decrease from Baseline \>30 millimeter of mercury (mmHg) in the same posture and \>170 or \<100 mmHg; increase or decrease from Baseline \>20 mmHg in same posture and \>110 or \<50 mmHg. |
| Change From Baseline in Body Weight Over Time | Baseline (Week 0) and Week -5 to 25 (Follow-up) | The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values. |
| Change From Baseline in Body Mass Index (BMI) Over Time | Baseline (Week 0) and Week -5 to 25 (Follow-up) | BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values. |
| Change From Baseline in Waist Circumference and Hip Circumference Over Time | Baseline (Week 0) up to Week 24 | Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values. |
| Mean Change From Baseline in Waist to Hip Ratio Over Time | Baseline (Week 0) up to Week 24 | Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values. |
| Change From Baseline in 12-lead ECG Over Time | Baseline (Week 0) up to Week 24 | 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values. |
| Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Up to Week 24 | The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase (\[LDH\] if \>2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized. |
| Number of Participants With Abnormal Urinalysis Dipstick Result | Up to Follow-up (Week 25) | The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25). |
| Number of Participants With Urinalysis Microscopic Result | Up to Follow-up (Week 25) | The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25). |
| Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN | Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20 | A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals. |
| Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK | Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20 | A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals. |
| Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Up to Week 25 | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities. |
Countries
Canada, Czechia, Finland, Germany, Greece, Latvia, Puerto Rico, Romania, Sweden, United States
Participant flow
Recruitment details
The study was conducted from 28 April 2005 to 21 July 2006 across 94 centres from 9 countries.
Pre-assignment details
A total of 375 participants received denagliptin (\[DEN\] 2.5, 7.5, 15, 30 or 45 milligram \[mg\]) or placebo which constituted the Safety Population. A total of 318 entered extension phase of study; 3 participants completed main phase but did not enter extension phase.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants. | 64 |
| DEN 2.5 mg Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants. | 61 |
| DEN 7.5 mg Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants. | 63 |
| DEN 15 mg Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants. | 66 |
| DEN 30 mg Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants. | 60 |
| DEN 45 mg Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants. | 61 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1: Main Phase (12 Weeks) | Adverse Event | 5 | 4 | 0 | 0 | 1 | 0 |
| Period 1: Main Phase (12 Weeks) | Decrease in hemoglobin and hematocrit | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Discontinued for not receiving incentive | 1 | 0 | 0 | 0 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Elevated triglycerides | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Fasting plasma glucose (FPG) below 140 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Insufficient therapeutic effect | 1 | 0 | 0 | 0 | 1 | 0 |
| Period 1: Main Phase (12 Weeks) | Lack of Efficacy | 3 | 0 | 0 | 1 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Lack of glycaemic control | 1 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Lost to Follow-up | 1 | 0 | 2 | 0 | 0 | 2 |
| Period 1: Main Phase (12 Weeks) | Not meet treatment eligibility criteria | 1 | 1 | 0 | 1 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Other-Protocol violator | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Participant moved out of area | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 1: Main Phase (12 Weeks) | Participant's study medication stolen | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 1: Main Phase (12 Weeks) | Participant went on extended holiday | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 1: Main Phase (12 Weeks) | Protocol Violation | 0 | 2 | 4 | 2 | 1 | 1 |
| Period 1: Main Phase (12 Weeks) | Sponsor requested withdrawal | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 1: Main Phase (12 Weeks) | Withdrawal by Subject | 2 | 2 | 3 | 0 | 0 | 1 |
| Period 1: Main Phase (12 Weeks) | Would have been a drop out at Visit 4 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Adverse Event | 0 | 2 | 1 | 3 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Electrocardiogram (ECG) results | 0 | 0 | 1 | 0 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Insufficient therapeutic effect | 1 | 1 | 0 | 1 | 1 | 1 |
| Period 2: Extension Phase (12 Weeks) | Lack of Efficacy | 1 | 0 | 1 | 1 | 0 | 1 |
| Period 2: Extension Phase (12 Weeks) | Lack of Glycaemic Control | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Participant received metformin | 0 | 0 | 1 | 0 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Protocol Violation | 0 | 1 | 1 | 0 | 0 | 0 |
| Period 2: Extension Phase (12 Weeks) | Withdrawal by Subject | 0 | 2 | 2 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | DEN 45 mg | DEN 30 mg | DEN 15 mg | DEN 7.5 mg | DEN 2.5 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.8 Years STANDARD_DEVIATION 10.89 | 59.6 Years STANDARD_DEVIATION 9.87 | 59.2 Years STANDARD_DEVIATION 7.85 | 58.8 Years STANDARD_DEVIATION 9.95 | 59.9 Years STANDARD_DEVIATION 7.97 | 60.4 Years STANDARD_DEVIATION 12.41 | 58.6 Years STANDARD_DEVIATION 9.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 12 Participants | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 20 Participants | 4 Participants | 1 Participants | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 340 Participants | 55 Participants | 53 Participants | 60 Participants | 57 Participants | 58 Participants |
| Sex: Female, Male Female | 32 Participants | 191 Participants | 32 Participants | 31 Participants | 33 Participants | 32 Participants | 31 Participants |
| Sex: Female, Male Male | 32 Participants | 184 Participants | 29 Participants | 29 Participants | 33 Participants | 31 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 61 | 0 / 63 | 0 / 66 | 0 / 60 | 0 / 61 |
| other Total, other adverse events | 6 / 64 | 5 / 61 | 8 / 63 | 11 / 66 | 6 / 60 | 3 / 61 |
| serious Total, serious adverse events | 1 / 64 | 1 / 61 | 2 / 63 | 0 / 66 | 4 / 60 | 3 / 61 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.
Time frame: Baseline (Week 0) and Week 12
Population: Intent-to Treat (ITT) Population was defined as all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | 0.46 Percentage of HbA1c | Standard Error 0.105 |
| DEN 2.5 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | 0.18 Percentage of HbA1c | Standard Error 0.107 |
| DEN 7.5 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | -0.07 Percentage of HbA1c | Standard Error 0.104 |
| DEN 15 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | 0.01 Percentage of HbA1c | Standard Error 0.102 |
| DEN 30 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | -0.34 Percentage of HbA1c | Standard Error 0.107 |
| DEN 45 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | -0.38 Percentage of HbA1c | Standard Error 0.105 |
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.06195% CI: [-0.58, 0.01]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-0.82, -0.24]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.00295% CI: [-0.74, -0.16]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-1.09, -0.5]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-1.13, -0.55]ANCOVA
Secondary
Change From Baseline in 12-lead ECG Over Time
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -1.9 Milliseconds (msec) | Standard Deviation 20.79 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | -4.0 Milliseconds (msec) | Standard Deviation 21.76 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | -4.7 Milliseconds (msec) | Standard Deviation 22.21 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | 9.2 Milliseconds (msec) | Standard Deviation 103.33 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | -4.6 Milliseconds (msec) | Standard Deviation 23.44 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | -5.1 Milliseconds (msec) | Standard Deviation 20.62 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | -0.6 Milliseconds (msec) | Standard Deviation 14.18 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | 10.8 Milliseconds (msec) | Standard Deviation 106.59 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | 1.4 Milliseconds (msec) | Standard Deviation 14.8 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | 5.9 Milliseconds (msec) | Standard Deviation 109.76 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | -25.5 Milliseconds (msec) | Standard Deviation 91.91 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | -5.0 Milliseconds (msec) | Standard Deviation 17.52 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | -0.2 Milliseconds (msec) | Standard Deviation 15.39 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | -6.5 Milliseconds (msec) | Standard Deviation 17.67 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | -0.4 Milliseconds (msec) | Standard Deviation 8.22 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | 1.4 Milliseconds (msec) | Standard Deviation 13.56 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | -6.7 Milliseconds (msec) | Standard Deviation 18.74 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | -6.1 Milliseconds (msec) | Standard Deviation 17.19 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | -2.0 Milliseconds (msec) | Standard Deviation 7.87 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | -3.8 Milliseconds (msec) | Standard Deviation 18.1 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | -1.2 Milliseconds (msec) | Standard Deviation 7.26 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | -1.5 Milliseconds (msec) | Standard Deviation 13.52 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | -5.4 Milliseconds (msec) | Standard Deviation 20.82 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | -7.5 Milliseconds (msec) | Standard Deviation 21.52 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | -1.9 Milliseconds (msec) | Standard Deviation 8.28 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | -7.7 Milliseconds (msec) | Standard Deviation 22.46 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | -6.8 Milliseconds (msec) | Standard Deviation 19.85 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | -2.4 Milliseconds (msec) | Standard Deviation 9.48 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | 13.3 Milliseconds (msec) | Standard Deviation 124.03 |
| Placebo | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | -7.2 Milliseconds (msec) | Standard Deviation 20.58 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | 1.0 Milliseconds (msec) | Standard Deviation 11.38 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | -6.6 Milliseconds (msec) | Standard Deviation 21.32 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | -5.6 Milliseconds (msec) | Standard Deviation 117.39 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | -5.7 Milliseconds (msec) | Standard Deviation 22.5 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | -1.4 Milliseconds (msec) | Standard Deviation 7.36 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | -1.7 Milliseconds (msec) | Standard Deviation 19.94 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -0.8 Milliseconds (msec) | Standard Deviation 17.21 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | -0.9 Milliseconds (msec) | Standard Deviation 18.52 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | -2.1 Milliseconds (msec) | Standard Deviation 22.13 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | -4.6 Milliseconds (msec) | Standard Deviation 13.17 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | -6.7 Milliseconds (msec) | Standard Deviation 21.53 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | -6.5 Milliseconds (msec) | Standard Deviation 15.93 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | -1.3 Milliseconds (msec) | Standard Deviation 8.29 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | -0.4 Milliseconds (msec) | Standard Deviation 17.29 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | -13.4 Milliseconds (msec) | Standard Deviation 107.74 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | 26.0 Milliseconds (msec) | Standard Deviation 99.73 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | -0.1 Milliseconds (msec) | Standard Deviation 7.84 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | -22.7 Milliseconds (msec) | Standard Deviation 107.49 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | 0.3 Milliseconds (msec) | Standard Deviation 13.03 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | 0.4 Milliseconds (msec) | Standard Deviation 13.38 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | -3.0 Milliseconds (msec) | Standard Deviation 14.83 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | -1.4 Milliseconds (msec) | Standard Deviation 7.64 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | -3.2 Milliseconds (msec) | Standard Deviation 15.93 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | -1.7 Milliseconds (msec) | Standard Deviation 17.94 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | -4.2 Milliseconds (msec) | Standard Deviation 22.27 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | -0.6 Milliseconds (msec) | Standard Deviation 11.79 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | 5.7 Milliseconds (msec) | Standard Deviation 115.66 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | -2.2 Milliseconds (msec) | Standard Deviation 17.47 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | -0.2 Milliseconds (msec) | Standard Deviation 6.85 |
| DEN 2.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | -5.1 Milliseconds (msec) | Standard Deviation 18.06 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | 2.2 Milliseconds (msec) | Standard Deviation 8.65 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | 0.3 Milliseconds (msec) | Standard Deviation 13.59 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | -1.1 Milliseconds (msec) | Standard Deviation 17.22 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | -1.4 Milliseconds (msec) | Standard Deviation 14.67 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | 0.0 Milliseconds (msec) | Standard Deviation 14.24 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | -1.5 Milliseconds (msec) | Standard Deviation 14.61 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | 2.1 Milliseconds (msec) | Standard Deviation 8.21 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | -0.5 Milliseconds (msec) | Standard Deviation 8.49 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | 0.1 Milliseconds (msec) | Standard Deviation 8.68 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | 1.5 Milliseconds (msec) | Standard Deviation 8.29 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | -1.1 Milliseconds (msec) | Standard Deviation 21.36 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | 0.4 Milliseconds (msec) | Standard Deviation 20.89 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | -2.1 Milliseconds (msec) | Standard Deviation 19.2 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | 1.8 Milliseconds (msec) | Standard Deviation 20.28 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | 1.2 Milliseconds (msec) | Standard Deviation 21.42 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -0.4 Milliseconds (msec) | Standard Deviation 19.51 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | -1.1 Milliseconds (msec) | Standard Deviation 20.65 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | -1.2 Milliseconds (msec) | Standard Deviation 18.28 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | -0.6 Milliseconds (msec) | Standard Deviation 23.84 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | 1.3 Milliseconds (msec) | Standard Deviation 20.06 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | -0.7 Milliseconds (msec) | Standard Deviation 17.28 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | -0.5 Milliseconds (msec) | Standard Deviation 17.66 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | -1.5 Milliseconds (msec) | Standard Deviation 15.42 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | 0.3 Milliseconds (msec) | Standard Deviation 19.1 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | 1.3 Milliseconds (msec) | Standard Deviation 16.65 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | -5.1 Milliseconds (msec) | Standard Deviation 100.41 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | 4.7 Milliseconds (msec) | Standard Deviation 104.53 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | -4.6 Milliseconds (msec) | Standard Deviation 102.36 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | 10.9 Milliseconds (msec) | Standard Deviation 119.81 |
| DEN 7.5 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | -1.7 Milliseconds (msec) | Standard Deviation 119.94 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | -4.0 Milliseconds (msec) | Standard Deviation 19.52 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | 0.7 Milliseconds (msec) | Standard Deviation 10.35 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | -5.7 Milliseconds (msec) | Standard Deviation 16.47 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | -4.4 Milliseconds (msec) | Standard Deviation 13.03 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | -1.1 Milliseconds (msec) | Standard Deviation 11.46 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | 1.0 Milliseconds (msec) | Standard Deviation 12.91 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | -3.8 Milliseconds (msec) | Standard Deviation 18.73 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | 0.0 Milliseconds (msec) | Standard Deviation 12.13 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | 11.3 Milliseconds (msec) | Standard Deviation 82.95 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | -1.8 Milliseconds (msec) | Standard Deviation 13.06 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | -0.3 Milliseconds (msec) | Standard Deviation 20.48 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | -1.9 Milliseconds (msec) | Standard Deviation 16.8 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | 1.0 Milliseconds (msec) | Standard Deviation 10.92 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | 0.3 Milliseconds (msec) | Standard Deviation 12.11 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | -2.8 Milliseconds (msec) | Standard Deviation 18.14 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | -3.2 Milliseconds (msec) | Standard Deviation 13.59 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | -2.7 Milliseconds (msec) | Standard Deviation 85.56 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | 0.4 Milliseconds (msec) | Standard Deviation 18.28 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | -3.5 Milliseconds (msec) | Standard Deviation 18.34 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -3.6 Milliseconds (msec) | Standard Deviation 14.95 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | -0.3 Milliseconds (msec) | Standard Deviation 14.05 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | -2.5 Milliseconds (msec) | Standard Deviation 18.14 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | -3.1 Milliseconds (msec) | Standard Deviation 118.09 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | 15.0 Milliseconds (msec) | Standard Deviation 88.09 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | -0.1 Milliseconds (msec) | Standard Deviation 12.1 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | 1.7 Milliseconds (msec) | Standard Deviation 13.56 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | -9.7 Milliseconds (msec) | Standard Deviation 75.09 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | -3.5 Milliseconds (msec) | Standard Deviation 21.66 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | -2.8 Milliseconds (msec) | Standard Deviation 15.1 |
| DEN 15 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | -0.1 Milliseconds (msec) | Standard Deviation 13.16 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | -1.3 Milliseconds (msec) | Standard Deviation 13.42 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | 0.8 Milliseconds (msec) | Standard Deviation 10.09 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -0.7 Milliseconds (msec) | Standard Deviation 18.37 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | -0.5 Milliseconds (msec) | Standard Deviation 7.56 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | -21.4 Milliseconds (msec) | Standard Deviation 103.46 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | 3.4 Milliseconds (msec) | Standard Deviation 17.15 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | 1.5 Milliseconds (msec) | Standard Deviation 17.86 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | 0.1 Milliseconds (msec) | Standard Deviation 7.29 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | 2.4 Milliseconds (msec) | Standard Deviation 20.2 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | 1.9 Milliseconds (msec) | Standard Deviation 17.9 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | -0.6 Milliseconds (msec) | Standard Deviation 7.4 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | -14.6 Milliseconds (msec) | Standard Deviation 97.99 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | -2.5 Milliseconds (msec) | Standard Deviation 15.28 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | -0.6 Milliseconds (msec) | Standard Deviation 7.8 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | 2.1 Milliseconds (msec) | Standard Deviation 15.11 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | -24.4 Milliseconds (msec) | Standard Deviation 99.46 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | -0.1 Milliseconds (msec) | Standard Deviation 13.35 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | 1.4 Milliseconds (msec) | Standard Deviation 13.17 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | 0.6 Milliseconds (msec) | Standard Deviation 16.97 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | 1.1 Milliseconds (msec) | Standard Deviation 13.07 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | 0.8 Milliseconds (msec) | Standard Deviation 16.16 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | -25.0 Milliseconds (msec) | Standard Deviation 101.94 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | 1.1 Milliseconds (msec) | Standard Deviation 14.19 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | -17.5 Milliseconds (msec) | Standard Deviation 97.17 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | -0.6 Milliseconds (msec) | Standard Deviation 21.32 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | -3.1 Milliseconds (msec) | Standard Deviation 17.18 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | 0.5 Milliseconds (msec) | Standard Deviation 14.18 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | -2.9 Milliseconds (msec) | Standard Deviation 20.11 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | -6.2 Milliseconds (msec) | Standard Deviation 20.34 |
| DEN 30 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | -1.3 Milliseconds (msec) | Standard Deviation 21.3 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week -5 | 0.2 Milliseconds (msec) | Standard Deviation 15.97 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 12 | -4.1 Milliseconds (msec) | Standard Deviation 23.38 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 24 | -0.1 Milliseconds (msec) | Standard Deviation 17.55 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week -5 | 0.4 Milliseconds (msec) | Standard Deviation 14.31 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 12 | -2.2 Milliseconds (msec) | Standard Deviation 104.03 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week -5 | 9.3 Milliseconds (msec) | Standard Deviation 102.6 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week -5 | -0.7 Milliseconds (msec) | Standard Deviation 19.55 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 4 | 0.8 Milliseconds (msec) | Standard Deviation 8.36 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 24 | 17.2 Milliseconds (msec) | Standard Deviation 115.09 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 16 | -0.3 Milliseconds (msec) | Standard Deviation 21.13 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 16 | 1.5 Milliseconds (msec) | Standard Deviation 23.05 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 4 | 23.1 Milliseconds (msec) | Standard Deviation 105.94 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 4 | 9.0 Milliseconds (msec) | Standard Deviation 18.34 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 24 | 4.3 Milliseconds (msec) | Standard Deviation 19.99 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 4 | -3.5 Milliseconds (msec) | Standard Deviation 22.94 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 12 | 0.9 Milliseconds (msec) | Standard Deviation 8.97 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 4 | 2.7 Milliseconds (msec) | Standard Deviation 17.44 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 12 | 0.1 Milliseconds (msec) | Standard Deviation 15.58 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week 12 | 0.2 Milliseconds (msec) | Standard Deviation 20.74 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 24 | -5.5 Milliseconds (msec) | Standard Deviation 21.87 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | RR interval, Week 16 | 3.6 Milliseconds (msec) | Standard Deviation 121.42 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 4 | 5.0 Milliseconds (msec) | Standard Deviation 13.05 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcB interval, Week 12 | 0.0 Milliseconds (msec) | Standard Deviation 18.96 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval,Week 16 | 0.4 Milliseconds (msec) | Standard Deviation 17.38 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | PR interval, Week 16 | -2.4 Milliseconds (msec) | Standard Deviation 20.76 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | UncQT, Week -5 | 1.6 Milliseconds (msec) | Standard Deviation 19.27 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 24 | -1.1 Milliseconds (msec) | Standard Deviation 8.33 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week -5 | 1.4 Milliseconds (msec) | Standard Deviation 8.65 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QRS duration, Week 16 | -0.8 Milliseconds (msec) | Standard Deviation 9.39 |
| DEN 45 mg | Change From Baseline in 12-lead ECG Over Time | QTcF interval, Week 24 | 1.4 Milliseconds (msec) | Standard Deviation 13.67 |
Secondary
Change From Baseline in Body Mass Index (BMI) Over Time
BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Time frame: Baseline (Week 0) and Week -5 to 25 (Follow-up)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.374 kg/meter square (m^2) | Standard Deviation 0.7989 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | -0.076 kg/meter square (m^2) | Standard Deviation 0.6281 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.165 kg/meter square (m^2) | Standard Deviation 0.4784 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | -0.025 kg/meter square (m^2) | Standard Deviation 0.5418 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.306 kg/meter square (m^2) | Standard Deviation 1.0187 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.494 kg/meter square (m^2) | Standard Deviation 1.1899 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.312 kg/meter square (m^2) | Standard Deviation 1.0837 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.311 kg/meter square (m^2) | Standard Deviation 0.7919 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.350 kg/meter square (m^2) | Standard Deviation 1.1468 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | -0.091 kg/meter square (m^2) | Standard Deviation 0.5994 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.108 kg/meter square (m^2) | Standard Deviation 0.6859 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.324 kg/meter square (m^2) | Standard Deviation 0.8814 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.158 kg/meter square (m^2) | Standard Deviation 0.7015 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.282 kg/meter square (m^2) | Standard Deviation 0.8331 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.233 kg/meter square (m^2) | Standard Deviation 0.6648 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.090 kg/meter square (m^2) | Standard Deviation 0.6028 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.375 kg/meter square (m^2) | Standard Deviation 0.8965 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.131 kg/meter square (m^2) | Standard Deviation 0.4948 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.303 kg/meter square (m^2) | Standard Deviation 0.9424 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | -0.169 kg/meter square (m^2) | Standard Deviation 0.587 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.237 kg/meter square (m^2) | Standard Deviation 0.8112 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.672 kg/meter square (m^2) | Standard Deviation 1.4019 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.494 kg/meter square (m^2) | Standard Deviation 1.1385 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.377 kg/meter square (m^2) | Standard Deviation 1.0859 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.292 kg/meter square (m^2) | Standard Deviation 0.634 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.524 kg/meter square (m^2) | Standard Deviation 1.2742 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.392 kg/meter square (m^2) | Standard Deviation 0.7566 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.571 kg/meter square (m^2) | Standard Deviation 1.2553 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | -0.037 kg/meter square (m^2) | Standard Deviation 0.3218 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.485 kg/meter square (m^2) | Standard Deviation 1.0575 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.353 kg/meter square (m^2) | Standard Deviation 0.7561 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | 0.015 kg/meter square (m^2) | Standard Deviation 0.6716 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.356 kg/meter square (m^2) | Standard Deviation 0.9912 |
| DEN 2.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.421 kg/meter square (m^2) | Standard Deviation 1.1495 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.111 kg/meter square (m^2) | Standard Deviation 0.3975 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.189 kg/meter square (m^2) | Standard Deviation 0.7403 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.255 kg/meter square (m^2) | Standard Deviation 0.7621 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.200 kg/meter square (m^2) | Standard Deviation 0.7002 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.152 kg/meter square (m^2) | Standard Deviation 0.8295 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.029 kg/meter square (m^2) | Standard Deviation 0.4579 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | -0.025 kg/meter square (m^2) | Standard Deviation 0.3264 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.183 kg/meter square (m^2) | Standard Deviation 0.6269 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | -0.089 kg/meter square (m^2) | Standard Deviation 0.3943 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.080 kg/meter square (m^2) | Standard Deviation 0.793 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | -0.140 kg/meter square (m^2) | Standard Deviation 0.4301 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.118 kg/meter square (m^2) | Standard Deviation 0.5153 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.128 kg/meter square (m^2) | Standard Deviation 0.6772 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.211 kg/meter square (m^2) | Standard Deviation 0.8145 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.247 kg/meter square (m^2) | Standard Deviation 0.6796 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.238 kg/meter square (m^2) | Standard Deviation 0.731 |
| DEN 7.5 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.098 kg/meter square (m^2) | Standard Deviation 0.5932 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.102 kg/meter square (m^2) | Standard Deviation 0.5311 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.080 kg/meter square (m^2) | Standard Deviation 0.4984 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.105 kg/meter square (m^2) | Standard Deviation 1.1095 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.064 kg/meter square (m^2) | Standard Deviation 0.6939 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.207 kg/meter square (m^2) | Standard Deviation 0.6319 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | -0.091 kg/meter square (m^2) | Standard Deviation 0.3694 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.014 kg/meter square (m^2) | Standard Deviation 0.7241 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.127 kg/meter square (m^2) | Standard Deviation 0.7081 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | 0.032 kg/meter square (m^2) | Standard Deviation 0.2852 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.015 kg/meter square (m^2) | Standard Deviation 0.4473 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.006 kg/meter square (m^2) | Standard Deviation 0.7797 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.041 kg/meter square (m^2) | Standard Deviation 1.0595 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.106 kg/meter square (m^2) | Standard Deviation 0.8592 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.107 kg/meter square (m^2) | Standard Deviation 0.5504 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.015 kg/meter square (m^2) | Standard Deviation 0.934 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | -0.094 kg/meter square (m^2) | Standard Deviation 0.4858 |
| DEN 15 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.095 kg/meter square (m^2) | Standard Deviation 0.4416 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.111 kg/meter square (m^2) | Standard Deviation 1.0993 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.538 kg/meter square (m^2) | Standard Deviation 0.862 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.393 kg/meter square (m^2) | Standard Deviation 0.838 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.231 kg/meter square (m^2) | Standard Deviation 0.8162 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | 0.057 kg/meter square (m^2) | Standard Deviation 0.4327 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | -0.130 kg/meter square (m^2) | Standard Deviation 0.7748 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.112 kg/meter square (m^2) | Standard Deviation 0.4597 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | -0.218 kg/meter square (m^2) | Standard Deviation 0.5059 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.211 kg/meter square (m^2) | Standard Deviation 0.7819 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.195 kg/meter square (m^2) | Standard Deviation 0.9608 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.157 kg/meter square (m^2) | Standard Deviation 1.0077 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.074 kg/meter square (m^2) | Standard Deviation 1.0056 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.243 kg/meter square (m^2) | Standard Deviation 0.7277 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.215 kg/meter square (m^2) | Standard Deviation 1.1414 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.138 kg/meter square (m^2) | Standard Deviation 1.1961 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.341 kg/meter square (m^2) | Standard Deviation 1.2751 |
| DEN 30 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.268 kg/meter square (m^2) | Standard Deviation 1.2877 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 13 | -0.083 kg/meter square (m^2) | Standard Deviation 0.968 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 12 | -0.179 kg/meter square (m^2) | Standard Deviation 0.8777 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 8 | -0.173 kg/meter square (m^2) | Standard Deviation 0.8603 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 6 | -0.103 kg/meter square (m^2) | Standard Deviation 0.8156 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -5 | 0.239 kg/meter square (m^2) | Standard Deviation 0.7085 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 20 | -0.171 kg/meter square (m^2) | Standard Deviation 0.9598 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 4 | 0.035 kg/meter square (m^2) | Standard Deviation 0.6149 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 3 | -0.069 kg/meter square (m^2) | Standard Deviation 0.5451 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 2 | -0.077 kg/meter square (m^2) | Standard Deviation 0.4441 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 25 | -0.107 kg/meter square (m^2) | Standard Deviation 1.0426 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 24 | -0.146 kg/meter square (m^2) | Standard Deviation 1.0313 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 1 | 0.030 kg/meter square (m^2) | Standard Deviation 0.3405 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -2 | 0.090 kg/meter square (m^2) | Standard Deviation 0.3338 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 15 | -0.103 kg/meter square (m^2) | Standard Deviation 0.9438 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 14 | -0.150 kg/meter square (m^2) | Standard Deviation 0.9222 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week -4 | 0.228 kg/meter square (m^2) | Standard Deviation 0.5114 |
| DEN 45 mg | Change From Baseline in Body Mass Index (BMI) Over Time | Week 16 | -0.147 kg/meter square (m^2) | Standard Deviation 0.8926 |
Secondary
Change From Baseline in Body Weight Over Time
The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Time frame: Baseline (Week 0) and Week -5 to 25 (Follow-up)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Weight Over Time | Week 24 | -1.35 Kilogram (kg) | Standard Deviation 3.343 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 1 | -0.06 Kilogram (kg) | Standard Deviation 1.547 |
| Placebo | Change From Baseline in Body Weight Over Time | Week -4 | 0.64 Kilogram (kg) | Standard Deviation 1.624 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 16 | -0.86 Kilogram (kg) | Standard Deviation 2.836 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 3 | -0.25 Kilogram (kg) | Standard Deviation 1.724 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 20 | -0.89 Kilogram (kg) | Standard Deviation 3.002 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 12 | -0.78 Kilogram (kg) | Standard Deviation 2.332 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 2 | -0.25 Kilogram (kg) | Standard Deviation 1.687 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 13 | -0.93 Kilogram (kg) | Standard Deviation 2.435 |
| Placebo | Change From Baseline in Body Weight Over Time | Week -5 | 1.09 Kilogram (kg) | Standard Deviation 2.138 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 25 | -0.97 Kilogram (kg) | Standard Deviation 3.207 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 6 | -0.47 Kilogram (kg) | Standard Deviation 1.394 |
| Placebo | Change From Baseline in Body Weight Over Time | Week -2 | 0.31 Kilogram (kg) | Standard Deviation 1.68 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 14 | -0.87 Kilogram (kg) | Standard Deviation 2.279 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 4 | -0.22 Kilogram (kg) | Standard Deviation 1.761 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 8 | -0.42 Kilogram (kg) | Standard Deviation 2.023 |
| Placebo | Change From Baseline in Body Weight Over Time | Week 15 | -1.06 Kilogram (kg) | Standard Deviation 2.54 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week -4 | 0.83 Kilogram (kg) | Standard Deviation 1.625 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 14 | -1.13 Kilogram (kg) | Standard Deviation 3.304 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 12 | -0.96 Kilogram (kg) | Standard Deviation 2.869 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 13 | -1.01 Kilogram (kg) | Standard Deviation 3.105 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week -2 | 0.64 Kilogram (kg) | Standard Deviation 1.175 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week -5 | 0.94 Kilogram (kg) | Standard Deviation 1.923 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 24 | -1.86 Kilogram (kg) | Standard Deviation 3.996 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 1 | -0.10 Kilogram (kg) | Standard Deviation 0.927 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 20 | -1.42 Kilogram (kg) | Standard Deviation 3.604 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 2 | 0.05 Kilogram (kg) | Standard Deviation 1.935 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 3 | -0.38 Kilogram (kg) | Standard Deviation 1.458 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 16 | -1.36 Kilogram (kg) | Standard Deviation 3.222 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 4 | -0.47 Kilogram (kg) | Standard Deviation 1.73 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 25 | -1.56 Kilogram (kg) | Standard Deviation 3.558 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 15 | -1.34 Kilogram (kg) | Standard Deviation 3.019 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 6 | -0.65 Kilogram (kg) | Standard Deviation 2.413 |
| DEN 2.5 mg | Change From Baseline in Body Weight Over Time | Week 8 | -0.82 Kilogram (kg) | Standard Deviation 2.743 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 13 | -0.68 Kilogram (kg) | Standard Deviation 1.988 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 1 | -0.06 Kilogram (kg) | Standard Deviation 0.928 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week -2 | 0.12 Kilogram (kg) | Standard Deviation 0.895 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week -4 | 0.25 Kilogram (kg) | Standard Deviation 1.178 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 4 | -0.42 Kilogram (kg) | Standard Deviation 1.21 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 14 | -0.52 Kilogram (kg) | Standard Deviation 2.012 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 15 | -0.72 Kilogram (kg) | Standard Deviation 2.072 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 12 | -0.71 Kilogram (kg) | Standard Deviation 1.885 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 24 | -0.24 Kilogram (kg) | Standard Deviation 2.185 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 8 | -0.38 Kilogram (kg) | Standard Deviation 1.817 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 2 | -0.26 Kilogram (kg) | Standard Deviation 1.085 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 20 | -0.59 Kilogram (kg) | Standard Deviation 2.225 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 16 | -0.56 Kilogram (kg) | Standard Deviation 1.92 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week -5 | 0.52 Kilogram (kg) | Standard Deviation 1.321 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 6 | -0.34 Kilogram (kg) | Standard Deviation 1.413 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 3 | -0.32 Kilogram (kg) | Standard Deviation 1.135 |
| DEN 7.5 mg | Change From Baseline in Body Weight Over Time | Week 25 | -0.45 Kilogram (kg) | Standard Deviation 2.264 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 13 | -0.20 Kilogram (kg) | Standard Deviation 1.971 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week -5 | 0.53 Kilogram (kg) | Standard Deviation 1.74 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week -2 | 0.01 Kilogram (kg) | Standard Deviation 1.167 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 1 | 0.10 Kilogram (kg) | Standard Deviation 0.818 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 2 | -0.24 Kilogram (kg) | Standard Deviation 1.06 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 3 | -0.25 Kilogram (kg) | Standard Deviation 1.266 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 4 | -0.28 Kilogram (kg) | Standard Deviation 1.386 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 6 | -0.30 Kilogram (kg) | Standard Deviation 1.601 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 8 | -0.25 Kilogram (kg) | Standard Deviation 1.45 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 12 | -0.36 Kilogram (kg) | Standard Deviation 2.009 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week -4 | 0.23 Kilogram (kg) | Standard Deviation 1.396 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 14 | -0.06 Kilogram (kg) | Standard Deviation 2.06 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 15 | -0.05 Kilogram (kg) | Standard Deviation 2.186 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 16 | -0.31 Kilogram (kg) | Standard Deviation 2.428 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 20 | -0.07 Kilogram (kg) | Standard Deviation 2.666 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 24 | -0.31 Kilogram (kg) | Standard Deviation 3.195 |
| DEN 15 mg | Change From Baseline in Body Weight Over Time | Week 25 | -0.13 Kilogram (kg) | Standard Deviation 3.048 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 14 | -0.11 Kilogram (kg) | Standard Deviation 2.781 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 1 | 0.22 Kilogram (kg) | Standard Deviation 1.396 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 15 | -0.24 Kilogram (kg) | Standard Deviation 2.991 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 20 | -0.30 Kilogram (kg) | Standard Deviation 3.275 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 6 | -0.68 Kilogram (kg) | Standard Deviation 2.07 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week -4 | 0.79 Kilogram (kg) | Standard Deviation 1.676 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week -2 | 0.35 Kilogram (kg) | Standard Deviation 1.529 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 3 | -0.31 Kilogram (kg) | Standard Deviation 1.364 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 25 | -0.65 Kilogram (kg) | Standard Deviation 3.492 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 24 | -0.82 Kilogram (kg) | Standard Deviation 3.517 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 4 | -0.60 Kilogram (kg) | Standard Deviation 1.448 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 12 | -0.51 Kilogram (kg) | Standard Deviation 2.745 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week -5 | 1.24 Kilogram (kg) | Standard Deviation 1.922 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 13 | -0.35 Kilogram (kg) | Standard Deviation 2.761 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 16 | -0.56 Kilogram (kg) | Standard Deviation 3.144 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 2 | -0.34 Kilogram (kg) | Standard Deviation 2.253 |
| DEN 30 mg | Change From Baseline in Body Weight Over Time | Week 8 | -0.56 Kilogram (kg) | Standard Deviation 2.213 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 1 | 0.09 Kilogram (kg) | Standard Deviation 1.023 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 14 | -0.46 Kilogram (kg) | Standard Deviation 2.513 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 16 | -0.45 Kilogram (kg) | Standard Deviation 2.471 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 4 | 0.10 Kilogram (kg) | Standard Deviation 1.722 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week -5 | 0.63 Kilogram (kg) | Standard Deviation 1.808 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 15 | -0.31 Kilogram (kg) | Standard Deviation 2.587 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 3 | -0.21 Kilogram (kg) | Standard Deviation 1.625 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 2 | -0.21 Kilogram (kg) | Standard Deviation 1.264 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 6 | -0.29 Kilogram (kg) | Standard Deviation 2.285 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 25 | -0.33 Kilogram (kg) | Standard Deviation 2.892 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 20 | -0.49 Kilogram (kg) | Standard Deviation 2.628 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week -2 | 0.20 Kilogram (kg) | Standard Deviation 0.894 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week -4 | 0.58 Kilogram (kg) | Standard Deviation 1.329 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 12 | -0.50 Kilogram (kg) | Standard Deviation 2.422 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 24 | -0.43 Kilogram (kg) | Standard Deviation 2.879 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 13 | -0.26 Kilogram (kg) | Standard Deviation 2.617 |
| DEN 45 mg | Change From Baseline in Body Weight Over Time | Week 8 | -0.48 Kilogram (kg) | Standard Deviation 2.435 |
Secondary
Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Time frame: Baseline (Week 0) and Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | -2.04 Picomole (pmol)/L | Standard Error 8.514 |
| Placebo | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -4.28 Picomole (pmol)/L | Standard Error 2.332 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | -10.55 Picomole (pmol)/L | Standard Error 8.804 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -0.97 Picomole (pmol)/L | Standard Error 2.418 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | 12.14 Picomole (pmol)/L | Standard Error 8.355 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -1.21 Picomole (pmol)/L | Standard Error 2.248 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | 5.27 Picomole (pmol)/L | Standard Error 8.057 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -4.63 Picomole (pmol)/L | Standard Error 2.228 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | 3.23 Picomole (pmol)/L | Standard Error 8.732 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -6.49 Picomole (pmol)/L | Standard Error 2.348 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Fasting serum insulin | 10.70 Picomole (pmol)/L | Standard Error 8.641 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 | Pro-insulin | -1.53 Picomole (pmol)/L | Standard Error 2.307 |
Comparison: Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.48995% CI: [-32.66, 15.65]ANCOVA
Comparison: Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.23795% CI: [-9.37, 37.72]ANCOVA
Comparison: Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.53495% CI: [-15.79, 30.42]ANCOVA
Comparison: Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.66595% CI: [-18.64, 29.17]ANCOVA
Comparison: Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.29595% CI: [-11.18, 36.65]ANCOVA
Comparison: Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.32795% CI: [-3.32, 9.94]ANCOVA
Comparison: Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.34595% CI: [-3.31, 9.44]ANCOVA
Comparison: Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.91495% CI: [-6.7, 6]ANCOVA
Comparison: Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.50495% CI: [-8.71, 4.29]ANCOVA
Comparison: Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.40395% CI: [-3.71, 9.22]ANCOVA
Secondary
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | 5.97 pmol/L | Standard Deviation 50.769 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | 6.35 pmol/L | Standard Deviation 55.319 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | 1.10 pmol/L | Standard Deviation 42.239 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | 0.00 pmol/L | Standard Deviation 18.948 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | 3.96 pmol/L | Standard Deviation 55.879 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -1.36 pmol/L | Standard Deviation 21.662 |
| Placebo | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | 9.89 pmol/L | Standard Deviation 73.956 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | -11.90 pmol/L | Standard Deviation 81.3 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | -0.65 pmol/L | Standard Deviation 96.114 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | -9.02 pmol/L | Standard Deviation 87.664 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | -6.66 pmol/L | Standard Deviation 85.054 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | -3.83 pmol/L | Standard Deviation 86.792 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | -4.23 pmol/L | Standard Deviation 16.204 |
| DEN 2.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -2.42 pmol/L | Standard Deviation 15.774 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | 20.68 pmol/L | Standard Deviation 148.343 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | 5.12 pmol/L | Standard Deviation 81.86 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | 2.85 pmol/L | Standard Deviation 75.79 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | 23.47 pmol/L | Standard Deviation 157.791 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -1.38 pmol/L | Standard Deviation 24.872 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | 22.79 pmol/L | Standard Deviation 148.597 |
| DEN 7.5 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | -3.48 pmol/L | Standard Deviation 16.865 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | 4.76 pmol/L | Standard Deviation 57.217 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | 1.67 pmol/L | Standard Deviation 55.221 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | 2.29 pmol/L | Standard Deviation 44.507 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | 1.05 pmol/L | Standard Deviation 56.293 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | 11.62 pmol/L | Standard Deviation 73.917 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -4.48 pmol/L | Standard Deviation 19.604 |
| DEN 15 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | -4.59 pmol/L | Standard Deviation 18.539 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | 11.11 pmol/L | Standard Deviation 33.429 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | 24.27 pmol/L | Standard Deviation 72.846 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | -3.88 pmol/L | Standard Deviation 18.139 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | 21.80 pmol/L | Standard Deviation 78.596 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -4.33 pmol/L | Standard Deviation 18.011 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | 11.56 pmol/L | Standard Deviation 41.611 |
| DEN 30 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | 8.07 pmol/L | Standard Deviation 36.118 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Pro-insulin | -4.45 pmol/L | Standard Deviation 26.313 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 24, Fasting serum insulin | 0.69 pmol/L | Standard Deviation 61.09 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 16, Fasting serum insulin | 9.83 pmol/L | Standard Deviation 108.783 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 8, Fasting serum insulin | 25.21 pmol/L | Standard Deviation 246.25 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Pro-insulin | -5.55 pmol/L | Standard Deviation 20.885 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 4, Fasting serum insulin | 7.23 pmol/L | Standard Deviation 96.413 |
| DEN 45 mg | Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 | Week 20, Fasting serum insulin | 0.68 pmol/L | Standard Deviation 50.704 |
Secondary
Change From Baseline in FPG at Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Time frame: Baseline (Week 0) and Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in FPG at Week 12 | 0.52 Millimole per liter (mmol/L) | Standard Error 0.273 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 12 | 0.11 Millimole per liter (mmol/L) | Standard Error 0.282 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 12 | -0.28 Millimole per liter (mmol/L) | Standard Error 0.272 |
| DEN 15 mg | Change From Baseline in FPG at Week 12 | -0.07 Millimole per liter (mmol/L) | Standard Error 0.27 |
| DEN 30 mg | Change From Baseline in FPG at Week 12 | -0.95 Millimole per liter (mmol/L) | Standard Error 0.281 |
| DEN 45 mg | Change From Baseline in FPG at Week 12 | -0.71 Millimole per liter (mmol/L) | Standard Error 0.276 |
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.30695% CI: [-1.18, 0.37]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.03995% CI: [-1.56, -0.04]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.1395% CI: [-1.34, 0.17]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-2.23, -0.69]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.00295% CI: [-1.99, -0.46]ANCOVA
Secondary
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | 0.16 mmol/L | Standard Deviation 1.906 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | 0.25 mmol/L | Standard Deviation 2.228 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | 0.34 mmol/L | Standard Deviation 2.348 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | 0.35 mmol/L | Standard Deviation 1.385 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | 0.39 mmol/L | Standard Deviation 1.745 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | 0.17 mmol/L | Standard Deviation 1.507 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | 0.16 mmol/L | Standard Deviation 1.934 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | 0.67 mmol/L | Standard Deviation 2.543 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | 0.33 mmol/L | Standard Deviation 1.247 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | 0.37 mmol/L | Standard Deviation 1.442 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | 0.16 mmol/L | Standard Deviation 1.95 |
| Placebo | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | 0.16 mmol/L | Standard Deviation 1.595 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | 0.21 mmol/L | Standard Deviation 2.149 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | 0.19 mmol/L | Standard Deviation 1.975 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | 0.07 mmol/L | Standard Deviation 2.381 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | 0.34 mmol/L | Standard Deviation 2.206 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | 0.23 mmol/L | Standard Deviation 2.113 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | 0.22 mmol/L | Standard Deviation 2.005 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | 0.18 mmol/L | Standard Deviation 2.178 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | 0.31 mmol/L | Standard Deviation 2.444 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | 0.53 mmol/L | Standard Deviation 2.807 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | 0.18 mmol/L | Standard Deviation 1.996 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | 0.39 mmol/L | Standard Deviation 2.898 |
| DEN 2.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | 0.28 mmol/L | Standard Deviation 2.305 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | -0.40 mmol/L | Standard Deviation 2.334 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | -0.50 mmol/L | Standard Deviation 2.235 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | -0.30 mmol/L | Standard Deviation 1.575 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | -0.04 mmol/L | Standard Deviation 2.549 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | -0.25 mmol/L | Standard Deviation 2.514 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | -0.52 mmol/L | Standard Deviation 2.235 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | -0.35 mmol/L | Standard Deviation 2.492 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | -0.19 mmol/L | Standard Deviation 2.226 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | -0.45 mmol/L | Standard Deviation 1.462 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | -0.65 mmol/L | Standard Deviation 1.814 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | -0.61 mmol/L | Standard Deviation 2.139 |
| DEN 7.5 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | -0.07 mmol/L | Standard Deviation 3.003 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | -0.41 mmol/L | Standard Deviation 1.91 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | -0.11 mmol/L | Standard Deviation 1.782 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | -0.28 mmol/L | Standard Deviation 1.603 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | -0.43 mmol/L | Standard Deviation 1.548 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | -0.28 mmol/L | Standard Deviation 1.42 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | -0.33 mmol/L | Standard Deviation 1.593 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | -0.21 mmol/L | Standard Deviation 2.016 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | -0.11 mmol/L | Standard Deviation 1.821 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | -0.29 mmol/L | Standard Deviation 1.828 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | 0.09 mmol/L | Standard Deviation 1.913 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | 0.22 mmol/L | Standard Deviation 2.186 |
| DEN 15 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | -0.25 mmol/L | Standard Deviation 1.46 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | -0.86 mmol/L | Standard Deviation 1.869 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | -0.81 mmol/L | Standard Deviation 1.591 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | -1.01 mmol/L | Standard Deviation 2.122 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | -1.04 mmol/L | Standard Deviation 2.038 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | -1.21 mmol/L | Standard Deviation 1.514 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | -0.84 mmol/L | Standard Deviation 2.175 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | -0.73 mmol/L | Standard Deviation 1.088 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | -0.66 mmol/L | Standard Deviation 1.514 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | -0.98 mmol/L | Standard Deviation 2.213 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | -0.88 mmol/L | Standard Deviation 1.904 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | -1.02 mmol/L | Standard Deviation 1.657 |
| DEN 30 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | -0.73 mmol/L | Standard Deviation 2.279 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 14 | -0.86 mmol/L | Standard Deviation 2.087 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 13 | -0.96 mmol/L | Standard Deviation 2.058 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 16 | -0.89 mmol/L | Standard Deviation 2.121 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 8 | -1.10 mmol/L | Standard Deviation 1.801 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 20 | -0.81 mmol/L | Standard Deviation 2.344 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 6 | -0.81 mmol/L | Standard Deviation 1.882 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 4 | -1.31 mmol/L | Standard Deviation 1.764 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 1 | -0.71 mmol/L | Standard Deviation 1.605 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 24 | -0.60 mmol/L | Standard Deviation 2.364 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 3 | -0.89 mmol/L | Standard Deviation 1.844 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 2 | -0.69 mmol/L | Standard Deviation 2.043 |
| DEN 45 mg | Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 | Week 15 | -0.89 mmol/L | Standard Deviation 1.952 |
Secondary
Change From Baseline in Fructosamine at Week 12
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Time frame: Baseline (Week 0) and Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fructosamine at Week 12 | 19.9 Micromole (µmol/L) | Standard Error 5.44 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Week 12 | 5.0 Micromole (µmol/L) | Standard Error 5.55 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Week 12 | -2.5 Micromole (µmol/L) | Standard Error 5.16 |
| DEN 15 mg | Change From Baseline in Fructosamine at Week 12 | -9.3 Micromole (µmol/L) | Standard Error 5.12 |
| DEN 30 mg | Change From Baseline in Fructosamine at Week 12 | -19.7 Micromole (µmol/L) | Standard Error 5.34 |
| DEN 45 mg | Change From Baseline in Fructosamine at Week 12 | -19.0 Micromole (µmol/L) | Standard Error 5.29 |
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.05795% CI: [-30.2, 0.5]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.00395% CI: [-37.1, -7.6]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-43.9, -14.5]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-54.6, -24.6]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: <0.00195% CI: [-53.8, -23.9]ANCOVA
Secondary
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | 14.7 µmol/L | Standard Deviation 54.1 |
| Placebo | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | 15.9 µmol/L | Standard Deviation 49.33 |
| Placebo | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | 10.3 µmol/L | Standard Deviation 38.09 |
| Placebo | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | 11.6 µmol/L | Standard Deviation 56.07 |
| Placebo | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | 8.2 µmol/L | Standard Deviation 48.67 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | -2.1 µmol/L | Standard Deviation 39.42 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | 3.3 µmol/L | Standard Deviation 51.12 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | -4.3 µmol/L | Standard Deviation 37.01 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | 6.7 µmol/L | Standard Deviation 53.75 |
| DEN 2.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | -0.5 µmol/L | Standard Deviation 48.06 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | -5.0 µmol/L | Standard Deviation 31.93 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | 0.3 µmol/L | Standard Deviation 39.36 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | 7.1 µmol/L | Standard Deviation 49.03 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | -3.0 µmol/L | Standard Deviation 39.37 |
| DEN 7.5 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | -2.9 µmol/L | Standard Deviation 34.08 |
| DEN 15 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | -3.5 µmol/L | Standard Deviation 45.02 |
| DEN 15 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | -10.1 µmol/L | Standard Deviation 33.64 |
| DEN 15 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | -7.7 µmol/L | Standard Deviation 32.84 |
| DEN 15 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | -2.0 µmol/L | Standard Deviation 46.96 |
| DEN 15 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | 7.0 µmol/L | Standard Deviation 47.77 |
| DEN 30 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | -9.6 µmol/L | Standard Deviation 47.49 |
| DEN 30 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | -14.8 µmol/L | Standard Deviation 29.36 |
| DEN 30 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | -11.0 µmol/L | Standard Deviation 48.02 |
| DEN 30 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | -20.2 µmol/L | Standard Deviation 34.06 |
| DEN 30 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | -12.8 µmol/L | Standard Deviation 43.62 |
| DEN 45 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 4 | -22.0 µmol/L | Standard Deviation 36.58 |
| DEN 45 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 20 | -17.3 µmol/L | Standard Deviation 42.07 |
| DEN 45 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 8 | -23.6 µmol/L | Standard Deviation 33.32 |
| DEN 45 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 24 | -10.9 µmol/L | Standard Deviation 41.81 |
| DEN 45 mg | Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 | Week 16 | -18.6 µmol/L | Standard Deviation 39.53 |
Secondary
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24
HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | 0.31 Percentage of HbA1c | Standard Deviation 1.171 |
| Placebo | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | 0.21 Percentage of HbA1c | Standard Deviation 1.019 |
| Placebo | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | 0.22 Percentage of HbA1c | Standard Deviation 0.672 |
| Placebo | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | 0.35 Percentage of HbA1c | Standard Deviation 1.252 |
| Placebo | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | 0.40 Percentage of HbA1c | Standard Deviation 1.146 |
| DEN 2.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | 0.13 Percentage of HbA1c | Standard Deviation 0.753 |
| DEN 2.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | 0.22 Percentage of HbA1c | Standard Deviation 1.143 |
| DEN 2.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | -0.01 Percentage of HbA1c | Standard Deviation 0.505 |
| DEN 2.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | 0.21 Percentage of HbA1c | Standard Deviation 1.184 |
| DEN 2.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | 0.14 Percentage of HbA1c | Standard Deviation 0.934 |
| DEN 7.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | -0.04 Percentage of HbA1c | Standard Deviation 0.789 |
| DEN 7.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | 0.02 Percentage of HbA1c | Standard Deviation 1.032 |
| DEN 7.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | 0.06 Percentage of HbA1c | Standard Deviation 1.095 |
| DEN 7.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | -0.04 Percentage of HbA1c | Standard Deviation 0.926 |
| DEN 7.5 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | -0.11 Percentage of HbA1c | Standard Deviation 0.586 |
| DEN 15 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | 0.05 Percentage of HbA1c | Standard Deviation 0.79 |
| DEN 15 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | -0.05 Percentage of HbA1c | Standard Deviation 0.474 |
| DEN 15 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | -0.04 Percentage of HbA1c | Standard Deviation 0.645 |
| DEN 15 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | 0.12 Percentage of HbA1c | Standard Deviation 0.853 |
| DEN 15 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | 0.16 Percentage of HbA1c | Standard Deviation 0.942 |
| DEN 30 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | -0.25 Percentage of HbA1c | Standard Deviation 0.96 |
| DEN 30 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | -0.25 Percentage of HbA1c | Standard Deviation 0.436 |
| DEN 30 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | -0.28 Percentage of HbA1c | Standard Deviation 0.994 |
| DEN 30 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | -0.36 Percentage of HbA1c | Standard Deviation 0.653 |
| DEN 30 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | -0.30 Percentage of HbA1c | Standard Deviation 0.968 |
| DEN 45 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 4 | -0.32 Percentage of HbA1c | Standard Deviation 0.445 |
| DEN 45 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 20 | -0.35 Percentage of HbA1c | Standard Deviation 0.823 |
| DEN 45 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 8 | -0.41 Percentage of HbA1c | Standard Deviation 0.579 |
| DEN 45 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 24 | -0.30 Percentage of HbA1c | Standard Deviation 0.9 |
| DEN 45 mg | Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 | Week 16 | -0.36 Percentage of HbA1c | Standard Deviation 0.821 |
Secondary
Change From Baseline in Pro-insulin at Week 16, 20 and 24.
The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: ITT Population without LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | -2.52 pmol/L | Standard Deviation 11.898 |
| Placebo | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -3.61 pmol/L | Standard Deviation 15.914 |
| Placebo | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -2.32 pmol/L | Standard Deviation 19.82 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | 1.11 pmol/L | Standard Deviation 26.455 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -0.64 pmol/L | Standard Deviation 21.485 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -4.45 pmol/L | Standard Deviation 20.161 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -0.65 pmol/L | Standard Deviation 31.694 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -3.27 pmol/L | Standard Deviation 16.672 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | -2.24 pmol/L | Standard Deviation 17.156 |
| DEN 15 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -4.24 pmol/L | Standard Deviation 25.786 |
| DEN 15 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | -4.95 pmol/L | Standard Deviation 17.947 |
| DEN 15 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -3.07 pmol/L | Standard Deviation 23.95 |
| DEN 30 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -4.47 pmol/L | Standard Deviation 20.598 |
| DEN 30 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -4.67 pmol/L | Standard Deviation 13.882 |
| DEN 30 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | -4.84 pmol/L | Standard Deviation 20.063 |
| DEN 45 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 20 | -2.23 pmol/L | Standard Deviation 22.27 |
| DEN 45 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 16 | -1.35 pmol/L | Standard Deviation 33.282 |
| DEN 45 mg | Change From Baseline in Pro-insulin at Week 16, 20 and 24. | Week 24 | -2.34 pmol/L | Standard Deviation 22.484 |
Secondary
Change From Baseline in Pro-insulin to Insulin Ratio at Week 12
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Time frame: Baseline (Week 0) and Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | -0.02 Ratio | Standard Error 0.018 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | 0.01 Ratio | Standard Error 0.019 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | -0.04 Ratio | Standard Error 0.018 |
| DEN 15 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | -0.06 Ratio | Standard Error 0.017 |
| DEN 30 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | -0.08 Ratio | Standard Error 0.018 |
| DEN 45 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 | -0.06 Ratio | Standard Error 0.018 |
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.28695% CI: [-0.02, 0.08]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.45795% CI: [-0.07, 0.03]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.13695% CI: [-0.09, 0.01]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.02195% CI: [-0.11, -0.01]ANCOVA
Comparison: A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.09495% CI: [-0.09, 0.01]ANCOVA
Secondary
Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Time frame: Baseline (Week 0) and Week 4 and 8
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.02 Ratio | Standard Deviation 0.197 |
| Placebo | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | 0.02 Ratio | Standard Deviation 0.133 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.03 Ratio | Standard Deviation 0.176 |
| DEN 2.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | -0.01 Ratio | Standard Deviation 0.229 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.03 Ratio | Standard Deviation 0.137 |
| DEN 7.5 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | -0.05 Ratio | Standard Deviation 0.12 |
| DEN 15 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.07 Ratio | Standard Deviation 0.169 |
| DEN 15 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | -0.07 Ratio | Standard Deviation 0.177 |
| DEN 30 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.13 Ratio | Standard Deviation 0.146 |
| DEN 30 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | -0.11 Ratio | Standard Deviation 0.174 |
| DEN 45 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 4 | -0.05 Ratio | Standard Deviation 0.137 |
| DEN 45 mg | Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8 | Week 8 | -0.07 Ratio | Standard Deviation 0.15 |
Secondary
Change From Baseline in Waist Circumference and Hip Circumference Over Time
Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | -0.1 Centimeter (cm) | Standard Deviation 5.55 |
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | -0.4 Centimeter (cm) | Standard Deviation 4.73 |
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | -1.6 Centimeter (cm) | Standard Deviation 4.37 |
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | 1.0 Centimeter (cm) | Standard Deviation 4.49 |
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | -1.1 Centimeter (cm) | Standard Deviation 4.9 |
| Placebo | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | -1.9 Centimeter (cm) | Standard Deviation 4.84 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | -0.5 Centimeter (cm) | Standard Deviation 4.36 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | 2.6 Centimeter (cm) | Standard Deviation 4.19 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | -1.0 Centimeter (cm) | Standard Deviation 5.38 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | 0.0 Centimeter (cm) | Standard Deviation 4.49 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | -2.7 Centimeter (cm) | Standard Deviation 5.37 |
| DEN 2.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | -0.5 Centimeter (cm) | Standard Deviation 4.47 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | -0.9 Centimeter (cm) | Standard Deviation 3.91 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | -1.0 Centimeter (cm) | Standard Deviation 3.26 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | 0.9 Centimeter (cm) | Standard Deviation 4.46 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | -0.3 Centimeter (cm) | Standard Deviation 4.47 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | -0.5 Centimeter (cm) | Standard Deviation 4.05 |
| DEN 7.5 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | -0.2 Centimeter (cm) | Standard Deviation 3.25 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | 0.9 Centimeter (cm) | Standard Deviation 5.16 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | 0.6 Centimeter (cm) | Standard Deviation 3.82 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | 0.0 Centimeter (cm) | Standard Deviation 5.11 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | 0.3 Centimeter (cm) | Standard Deviation 4.8 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | -0.4 Centimeter (cm) | Standard Deviation 3.39 |
| DEN 15 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | -0.3 Centimeter (cm) | Standard Deviation 3.92 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | 0.6 Centimeter (cm) | Standard Deviation 5.31 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | -0.1 Centimeter (cm) | Standard Deviation 4.78 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | -0.1 Centimeter (cm) | Standard Deviation 4.77 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | -0.9 Centimeter (cm) | Standard Deviation 6.03 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | -1.4 Centimeter (cm) | Standard Deviation 4.97 |
| DEN 30 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | -1.1 Centimeter (cm) | Standard Deviation 7.13 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week -5 | 1.3 Centimeter (cm) | Standard Deviation 6.08 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 24 | -1.1 Centimeter (cm) | Standard Deviation 3.67 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 12 | 1.2 Centimeter (cm) | Standard Deviation 7.6 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Waist circumference, Week 24 | -0.8 Centimeter (cm) | Standard Deviation 5.7 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week 12 | -2.6 Centimeter (cm) | Standard Deviation 6.25 |
| DEN 45 mg | Change From Baseline in Waist Circumference and Hip Circumference Over Time | Hip circumference, Week -5 | -0.2 Centimeter (cm) | Standard Deviation 4.61 |
Secondary
Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Time frame: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
Population: PPK Population. The data for this outcome measure was not collected.
Secondary
Mean Change From Baseline in Waist to Hip Ratio Over Time
Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Time frame: Baseline (Week 0) up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | -0.01 Ratio | Standard Deviation 0.054 |
| Placebo | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | -0.00 Ratio | Standard Deviation 0.054 |
| Placebo | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | 0.01 Ratio | Standard Deviation 0.086 |
| DEN 2.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | -0.00 Ratio | Standard Deviation 0.07 |
| DEN 2.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | 0.02 Ratio | Standard Deviation 0.063 |
| DEN 2.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | 0.01 Ratio | Standard Deviation 0.064 |
| DEN 7.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | -0.01 Ratio | Standard Deviation 0.037 |
| DEN 7.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | 0.01 Ratio | Standard Deviation 0.063 |
| DEN 7.5 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | -0.01 Ratio | Standard Deviation 0.039 |
| DEN 15 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | 0.00 Ratio | Standard Deviation 0.064 |
| DEN 15 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | 0.01 Ratio | Standard Deviation 0.067 |
| DEN 15 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | -0.01 Ratio | Standard Deviation 0.047 |
| DEN 30 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | -0.00 Ratio | Standard Deviation 0.067 |
| DEN 30 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | -0.02 Ratio | Standard Deviation 0.06 |
| DEN 30 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | -0.00 Ratio | Standard Deviation 0.083 |
| DEN 45 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 12 | 0.03 Ratio | Standard Deviation 0.109 |
| DEN 45 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week -5 | 0.01 Ratio | Standard Deviation 0.086 |
| DEN 45 mg | Mean Change From Baseline in Waist to Hip Ratio Over Time | Week 24 | 0.00 Ratio | Standard Deviation 0.051 |
Secondary
Number of Participants of FPG Responders at Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of \<7 mmol/L and FPG reduction value of \>=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Time frame: Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 5 Participants |
| Placebo | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 8 Participants |
| DEN 2.5 mg | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 8 Participants |
| DEN 2.5 mg | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 12 Participants |
| DEN 7.5 mg | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 9 Participants |
| DEN 7.5 mg | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 13 Participants |
| DEN 15 mg | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 4 Participants |
| DEN 15 mg | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 10 Participants |
| DEN 30 mg | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 6 Participants |
| DEN 30 mg | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 18 Participants |
| DEN 45 mg | Number of Participants of FPG Responders at Week 12 | FPG <7 mmol/L | 9 Participants |
| DEN 45 mg | Number of Participants of FPG Responders at Week 12 | FPG reduction >=1.7 mmol/L | 18 Participants |
Comparison: Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.3895% CI: [0.5, 6.3]Regression, Logistic
Comparison: Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.14595% CI: [0.72, 9.11]Regression, Logistic
Comparison: Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.90695% CI: [0.26, 4.62]Regression, Logistic
Comparison: Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.50995% CI: [0.41, 5.91]Regression, Logistic
Comparison: Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.07795% CI: [0.89, 11.14]Regression, Logistic
Comparison: Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.25495% CI: [0.63, 5.72]Regression, Logistic
Comparison: Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.39695% CI: [0.55, 4.62]Regression, Logistic
Comparison: Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.5995% CI: [0.45, 4]Regression, Logistic
Comparison: Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.02695% CI: [1.15, 9.13]Regression, Logistic
Comparison: Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.03495% CI: [1.08, 8.3]Regression, Logistic
Secondary
Number of Participants Who Were HbA1c Responders at Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of \<=6.5%, \<7% and HbA1c reduction of \>=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Time frame: Week 12
Population: ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 11 Participants |
| Placebo | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 6 Participants |
| Placebo | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 10 Participants |
| DEN 2.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 9 Participants |
| DEN 2.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 4 Participants |
| DEN 2.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 6 Participants |
| DEN 7.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 12 Participants |
| DEN 7.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 4 Participants |
| DEN 7.5 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 14 Participants |
| DEN 15 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 9 Participants |
| DEN 15 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 5 Participants |
| DEN 15 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 10 Participants |
| DEN 30 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 14 Participants |
| DEN 30 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 9 Participants |
| DEN 30 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 21 Participants |
| DEN 45 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <=6.5% | 8 Participants |
| DEN 45 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c reduction >=0.7% | 17 Participants |
| DEN 45 mg | Number of Participants Who Were HbA1c Responders at Week 12 | HbA1c <7% | 14 Participants |
Comparison: Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.90995% CI: [0.21, 3.95]Regression, Logistic
Comparison: Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.85295% CI: [0.27, 4.92]Regression, Logistic
Comparison: Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.79595% CI: [0.3, 4.83]Regression, Logistic
Comparison: Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.13595% CI: [0.74, 9.77]Regression, Logistic
Comparison: Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.08595% CI: [0.85, 12.37]Regression, Logistic
Comparison: Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.86695% CI: [0.36, 3.36]Regression, Logistic
Comparison: Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.20295% CI: [0.69, 5.76]Regression, Logistic
Comparison: Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.94195% CI: [0.35, 3.13]Regression, Logistic
Comparison: Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.15295% CI: [0.76, 6.13]Regression, Logistic
Comparison: Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.03295% CI: [1.11, 9.52]Regression, Logistic
Comparison: Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.19895% CI: [0.14, 1.5]Regression, Logistic
Comparison: Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.48195% CI: [0.53, 3.85]Regression, Logistic
Comparison: Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.99195% CI: [0.36, 2.78]Regression, Logistic
Comparison: Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.00895% CI: [1.41, 9.48]Regression, Logistic
Comparison: Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.p-value: 0.16195% CI: [0.76, 5.24]Regression, Logistic
Secondary
Number of Participants With Abnormal Urinalysis Dipstick Result
The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Time frame: Up to Follow-up (Week 25)
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 10 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 9 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 5 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 7 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 5 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 8 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 6 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 4 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 8 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 8 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 10 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 8 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 6 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 3 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 1 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 0 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 2.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 7 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 9 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 9 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 11 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 8 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 9 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 1 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 9 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 2 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 3 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| DEN 7.5 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 8 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 8 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 9 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 8 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 1 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 9 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 6 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 4 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 3 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 2 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 5 Participants |
| DEN 15 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 7 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 8 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 7 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 6 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 0 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 2 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, trace | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, trace | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 2+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 1+ | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, trace | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, trace | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, trace | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 2+ or 1/2 g/dL | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, trace or 1/10 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, trace | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein,1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, trace | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein,1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Ketones, trace | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Glucose, trace or 1/10 g/dL | 9 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 2+ or 1/2 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 3+ or 1 g/dL | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 3+ or 1 g/dL | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, trace | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 3+ or 1 g/dL | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, trace | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 2+ or 1/2 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 3+ or 1 g/dL | 8 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, trace | 6 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 25, Glucose, 1+ or 1/4 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, 1+ or 1/4 g/dL | 6 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, trace or 1/10 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Protein, trace | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Ketones, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Protein, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein,1+ | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Ketones, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, trace | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Glucose, 3+ or 1 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, trace or 1/10 g/dL | 6 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Glucose, trace or 1/10 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 12, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Ketones, trace | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Protein, trace | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 2, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 1+ or 1/4 g/dL | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 15, Glucose, trace or 1/10 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 1+ or 1/4 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 20, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 13, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 1+ or 1/4 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week -5, Protein,1+ | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 6, Ketones, trace | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 2+ or 1/2 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 3+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 16, Protein, 1+ | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 8, Protein, 1+ | 2 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Protein, 1+ | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Glucose, 3+ or 1 g/dL | 4 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Glucose, 3+ or 1 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 2+ or 1/2 g/dL | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, 1+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 0, Glucose, 1+ or 1/4 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Ketones, trace | 1 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 4, Protein, 2+ | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 24, Ketones, trace | 0 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 14, Glucose, 3+ or 1 g/dL | 3 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 1, Glucose, 3+ or 1 g/dL | 5 Participants |
| DEN 45 mg | Number of Participants With Abnormal Urinalysis Dipstick Result | Week 3, Protein, 1+ | 3 Participants |
Secondary
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.
Time frame: Up to Week 25
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 16 Participants |
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 12 Participants |
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 0 Participants |
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 2 Participants |
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| Placebo | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 14 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 0 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 7 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 5 Participants |
| DEN 2.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 0 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 1 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 21 Participants |
| DEN 7.5 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 9 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 2 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 21 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 1 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| DEN 15 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 14 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 9 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 17 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 3 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 0 Participants |
| DEN 30 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Mild | 0 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Severe | 5 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Moderate | 0 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | Hypoglycaemia-Severe | 0 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Moderate | 11 Participants |
| DEN 45 mg | Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe | AE-Mild | 14 Participants |
Secondary
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.
Time frame: Up to Week 25
Population: Safety population was defined as all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 1 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 28 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 2 Participants |
| DEN 2.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 1 Participants |
| DEN 2.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 26 Participants |
| DEN 2.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 0 Participants |
| DEN 7.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 2 Participants |
| DEN 7.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 31 Participants |
| DEN 7.5 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 0 Participants |
| DEN 15 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 0 Participants |
| DEN 15 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 36 Participants |
| DEN 15 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 2 Participants |
| DEN 30 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 4 Participants |
| DEN 30 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 29 Participants |
| DEN 30 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 0 Participants |
| DEN 45 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any AE | 30 Participants |
| DEN 45 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any event of hypoglycaemia | 0 Participants |
| DEN 45 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia | Any SAE | 3 Participants |
Secondary
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy
The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline \>30 beats per minute (bpm) and \<50 or \>120 bpm; SBP increase or decrease from Baseline \>30 millimeter of mercury (mmHg) in the same posture and \>170 or \<100 mmHg; increase or decrease from Baseline \>20 mmHg in same posture and \>110 or \<50 mmHg.
Time frame: Baseline (Week 0) up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 4 Participants |
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 4 Participants |
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 1 Participants |
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 3 Participants |
| Placebo | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 3 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 4 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 0 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 3 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 2 Participants |
| DEN 2.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 3 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 2 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 3 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 1 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 1 Participants |
| DEN 7.5 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 2 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 5 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 0 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 4 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 4 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 2 Participants |
| DEN 15 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 3 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 4 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 3 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 1 Participants |
| DEN 30 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 4 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, Low | 0 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, High | 6 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | SBP, Low | 1 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, High | 2 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | DBP, Low | 3 Participants |
| DEN 45 mg | Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy | HR, High | 0 Participants |
Secondary
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy
The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase (\[LDH\] if \>2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Time frame: Up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 3 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 2 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 0 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 11 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 3 Participants |
| Placebo | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 5 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 2 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 4 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 5 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 1 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 5 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 6 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 2 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 8 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 1 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 3 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 7 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 4 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 2 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 3 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 2 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 7 Participants |
| DEN 30 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Potassium,high | 10 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Uric scid, high | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Total bilirubin, high | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, high | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Carbon dioxide content/bicarbonate, low | 7 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Glucose, low | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Sodium, low | 2 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Calcium, Low | 10 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | AST, high | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Creatinine, high | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Phosphorus inorganic, high | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy | Albumin, High | 1 Participants |
Secondary
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy
The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Time frame: Up to Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 3 Participants |
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 0 Participants |
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 0 Participants |
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 3 Participants |
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 1 Participants |
| Placebo | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 1 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 1 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 4 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 0 Participants |
| DEN 2.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 3 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 2 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 0 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 3 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 1 Participants |
| DEN 7.5 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 0 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 1 Participants |
| DEN 15 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 0 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 2 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 1 Participants |
| DEN 30 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | WBC count, high | 1 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, high | 2 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Platelet count, low | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, high | 2 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hemoglobin, low | 0 Participants |
| DEN 45 mg | Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy | Hematocrit, low | 1 Participants |
Secondary
Number of Participants With Urinalysis Microscopic Result
The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Time frame: Up to Follow-up (Week 25)
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 6 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 6 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 6 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 7 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 6 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 5 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 2 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 4 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 6 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 6 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 6 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 5 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 4 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 0 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 3 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 2 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 1 Participants |
| DEN 2.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 6 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 6 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 5 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 5 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 5 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 3 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 4 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 0 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 2 Participants |
| DEN 7.5 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 6 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 4 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 5 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 2 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 1 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 3 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| DEN 15 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 6 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 5 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 5 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 9 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 8 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 5 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 6 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 6 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 6 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 5 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 6 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 2 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 5 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 3 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 7 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 4 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 1 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| DEN 30 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 3-5 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 25-50 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 5-10 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 1-3 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 0-1 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 5-10 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, ,25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 5-10 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 3-5 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 1-3 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 5-10 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 1-3 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 0-1 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 1-3 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 1-3 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 25-50 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 10-15 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 25-50 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 1-3 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 5-10 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 3-5 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 3-5 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 25-50 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 15-25 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 25-50 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 1-3 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 3-5 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 10-15 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, WBC, 5-10 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 1-3 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 4, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 50-100 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 25-50 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, WBC, 3-5 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 3, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, WBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 50-100 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 25-50 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, WBC, 0-1 | 6 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 0-1 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, WBC, 15-25 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 50-100 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, WBC, 1-3 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 5-10 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 15-25 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 6, WBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 2, RBC, 3-5 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week -5, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 1, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, RBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 1-3 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 0-1 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 15, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, 1-3 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 24, WBC, 25-50 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 1-3 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, RBC, 0-1 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, innumerable | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 25-50 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 1-3 | 4 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 25, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 12, WBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 5-10 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 25-50 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 50-100 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 10-15 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 5-10 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 13, WBC, 3-5 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 25-50 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, 15-25 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 15-25 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 8, WBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, RBC, innumerable | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 5-10 | 2 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 3-5 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, WBC, 1-3 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 25-50 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 0, RBC, 50-100 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 14, WBC, 0-1 | 3 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 15-25 | 0 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 20, RBC, 0-1 | 1 Participants |
| DEN 45 mg | Number of Participants With Urinalysis Microscopic Result | Week 16, WBC, innumerable | 0 Participants |
Secondary
Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Time frame: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
Population: Sparse PK (PPK) Population comprised of all those participants who were assigned to the sparse (population PK) group. All consenting participants were eligible for inclusion in the sparse PK population except for those participants participating in the serial PK assessment. The data for this outcome measure was not collected.