Bigg Pharmaceutical Company

BP3304-002

Summary Tables
Table of Contents
Table [Link] Subject Disposition
Table [Link] Subject Disposition by Site
Table [Link] Subject Demographics and Baseline Characteristics – Safety Population
Table [Link] Subject Demographics and Baseline Characteristics – Modified Intent-to-Treat Population
Table [Link] Subject Demographics and Baseline Characteristics – Per Protocol Population
Table 14.1.3 Subject Evaluability
Table [Link] Prior Medications
Table [Link] Concomitant Treatment Phase Medications
Table [Link] Concomitant Follow-up Phase Medications
Table [Link] Exposure to Study Medication – Safety Population
Table [Link] Exposure to Study Medication – Modified Intent-to-Treat Population
Table [Link] Exposure to Study Medication – Per Protocol Population
Table [Link] Treatment Compliance – Safety Population
Table [Link] Treatment Compliance – Modified Intent-to-Treat Population
Table [Link] Diastolic Blood Pressure - Modified Intent-to-Treat Population
Table [Link]. Diastolic Blood Pressure – Per Protocol Population
Table [Link] Systolic Blood Pressure - Modified Intent-to-Treat Population
Table [Link]. Systolic Blood Pressure – Per Protocol Population
Table [Link] Diastolic Blood Pressure by Age Group - Modified Intent-to-Treat Population
Table [Link]. Diastolic Blood Pressure by Age Group – Per Protocol Population
Table [Link] Diastolic Blood Pressure by Duration of Hypertension - Modified Intent-to-Treat Population
Table [Link]. Diastolic Blood Pressure by Duration of Hypertension – Per Protocol Population
Table [Link] Time to Achievement of Diastolic Blood Pressure ≤ 90 mmHg- Modified Intent-to-Treat Population
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BP3304-002

Table [Link] Time to Achievement of Diastolic Blood Pressure ≤ 90 mmHg- Per Protocol Population
Table [Link]. Proportion of Patients Achieving Diastolic Blood Pressure ≤ 90 mmHg- Modified Intent-to-Treat
Population
Table [Link]. Proportion of Patients Achieving Diastolic Blood Pressure ≤ 90 mmHg- Per Protocol Population
Table [Link].1 Overall Summary of Treatment Emergent Adverse Events - Safety Population
Table [Link].2.1 Treatment Emergent Adverse Events by System Organ Class - Safety Population
Table [Link].2.2 Treatment Related Treatment Emergent Adverse Events by System Organ Class - Safety Population
Table [Link].3.1 Severe Treatment Emergent Adverse Events by System Organ Class - Safety Population
Table [Link].3.2 Severe Treatment Related Treatment Emergent Adverse Events by System Organ Class - Safety
Population
Table [Link].4.1 Treatment Emergent Adverse Events Reported by > 5% of BP3304 Patients by System Organ Class –
Safety Population
Table [Link].4.2 Treatment Related Treatment Emergent Adverse Events Reported by > 5% of BP3304 Patients by
System Organ Class – Safety Population
Table [Link].1 Treatment Emergent Adverse Events by System Organ Class – Safety Population
Table [Link].2 Treatment Related Treatment Emergent Adverse Events by System Organ Class – Safety Population
Table [Link].3 Treatment Emergent Adverse Events Resulting in Death by System Organ Class – Safety Population
Table [Link].4 Treatment Related Treatment Emergent Adverse Events Resulting in Death by System Organ Class –
Safety Population
Table [Link] Treatment-Emergent Adverse Events by Maximum Severity and System Organ Class– Safety
Population
Table [Link] Adverse Events Resulting in Death – Safety Population
Table [Link] Non-fatal Serious Adverse Events – Safety Population
Table [Link] Adverse Events Resulting in Study Discontinuation – Safety Population
Table [Link] Serum Chemistry Laboratory Parameters - Safety Population
Table [Link] Hematology Laboratory Parameters - Safety Population
Table [Link] Shifts from Baseline in Serum Chemistry Laboratory Parameters - Safety Population
Table [Link] Shifts from Baseline in Hematology Laboratory Parameters - Safety Population
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BP3304-002

Table [Link] Shifts from Baseline in Urinalysis Laboratory Parameters - Safety Population
Table [Link] Clinically Significant Laboratory Results During Treatment Phase - Safety Population
Table [Link] Vital Signs - Safety Population
Table [Link] Clinically Significant Vital Signs During Treatment Phase - Safety Population
Table [Link] Electrocardiogram Overall Results - Safety Population
Table [Link] Electrocardiogram Results by Parameter - Safety Population
Table [Link] Screening Physical Examination - Safety Population
Table [Link] Follow-up Physical Examination - Safety Population
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[Link] Subject Disposition

BP3304 Placebo Overall

n (%) n (%) n (%)
Enrolled xx

Withdrew Before Randomization xx (xx.x)

Exclusionary Laboratory Values xx (xx.x)
Non-Laboratory Safety Exclusions xx (xx.x)
Excluded Concomitant Medication xx (xx.x)
Other xx (xx.x)

Randomized xx xx xx

Completed Treatment Phase xx (xx.x) xx (xx.x) xx (xx.x)

Discontinued Treatment Phase xx (xx.x) xx (xx.x) xx (xx.x)

Administrative Reasons by Sponsor xx (xx.x) xx (xx.x) xx (xx.x)
Adverse Event xx (xx.x) xx (xx.x) xx (xx.x)
Death xx (xx.x) xx (xx.x) xx (xx.x)
Did Not Meet Inclusion Criteria xx (xx.x) xx (xx.x) xx (xx.x)
Lost to Follow-up xx (xx.x) xx (xx.x) xx (xx.x)
Non-compliance xx (xx.x) xx (xx.x) xx (xx.x)
Protocol Deviation xx (xx.x) xx (xx.x) xx (xx.x)
Withdrawn by Investigator xx (xx.x) xx (xx.x) xx (xx.x)
Patient Withdrew Consent xx (xx.x) xx (xx.x) xx (xx.x)
Other xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listings 16.2.1 and 16.2.2

Note: Percentages for reasons withdrawn before randomization are based on the number of enrolled subjects.
All other percentages are based on the number of randomized subjects.
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[Link] Subject Disposition

BP3304 Placebo Overall

n (%) n (%) n (%)
Randomized xx xx xx

Entered Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Completed Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Discontinued Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Administrative Reasons by Sponsor xx (xx.x) xx (xx.x) xx (xx.x)
Adverse Event xx (xx.x) xx (xx.x) xx (xx.x)
Death xx (xx.x) xx (xx.x) xx (xx.x)
Did Not Meet Inclusion Criteria xx (xx.x) xx (xx.x) xx (xx.x)
Lost to Follow-up xx (xx.x) xx (xx.x) xx (xx.x)
Non-compliance xx (xx.x) xx (xx.x) xx (xx.x)
Protocol Deviation xx (xx.x) xx (xx.x) xx (xx.x)
Withdrawn by Investigator xx (xx.x) xx (xx.x) xx (xx.x)
Patient Withdrew Consent xx (xx.x) xx (xx.x) xx (xx.x)
Other xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listings 16.2.1 and 16.2.2

Note: Percentages are based on the number of randomized subjects.
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[Link] Subject Disposition by Site

Site: xxx
BP3304 Placebo Overall
n (%) n (%) n (%)
Enrolled xx

Withdrew Before Randomization xx (xx.x)

Exclusionary Laboratory Values xx (xx.x)
Non-Laboratory Safety Exclusions xx (xx.x)
Excluded Concomitant Medication xx (xx.x)
Other xx (xx.x)

Randomized xx xx xx

Completed Treatment Phase xx (xx.x) xx (xx.x) xx (xx.x)

Discontinued Treatment Phase xx (xx.x) xx (xx.x) xx (xx.x)

Administrative Reasons by Sponsor xx (xx.x) xx (xx.x) xx (xx.x)
Adverse Event xx (xx.x) xx (xx.x) xx (xx.x)
Death xx (xx.x) xx (xx.x) xx (xx.x)
Did Not Meet Inclusion Criteria xx (xx.x) xx (xx.x) xx (xx.x)
Lost to Follow-up xx (xx.x) xx (xx.x) xx (xx.x)
Non-compliance xx (xx.x) xx (xx.x) xx (xx.x)
Protocol Deviation xx (xx.x) xx (xx.x) xx (xx.x)
Withdrawn by Investigator xx (xx.x) xx (xx.x) xx (xx.x)
Patient Withdrew Consent xx (xx.x) xx (xx.x) xx (xx.x)
Other xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listings 16.2.1 and 16.2.2

Note: Percentages for reasons withdrawn before randomization are based on the number of enrolled subjects.
All other percentages are based on the number of randomized subjects.
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[Link] Subject Disposition by Site

Site: xxx
BP3304 Placebo Overall
n (%) n (%) n (%)
Randomized xx xx xx

Entered Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Completed Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Discontinued Follow-up Phase xx (xx.x) xx (xx.x) xx (xx.x)

Administrative Reasons by Sponsor xx (xx.x) xx (xx.x) xx (xx.x)
Adverse Event xx (xx.x) xx (xx.x) xx (xx.x)
Death xx (xx.x) xx (xx.x) xx (xx.x)
Did Not Meet Inclusion Criteria xx (xx.x) xx (xx.x) xx (xx.x)
Lost to Follow-up xx (xx.x) xx (xx.x) xx (xx.x)
Non-compliance xx (xx.x) xx (xx.x) xx (xx.x)
Protocol Deviation xx (xx.x) xx (xx.x) xx (xx.x)
Withdrawn by Investigator xx (xx.x) xx (xx.x) xx (xx.x)
Patient Withdrew Consent xx (xx.x) xx (xx.x) xx (xx.x)
Other xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listings 16.2.1 and 16.2.2

Note: Percentages are based on the number of randomized subjects.
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[Link] Subject Demographics and Baseline Characteristics

Safety Population

BP3304 Placebo Overall

(N =xx) (N =xx) (N=xx)
Age (years)
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Gender [n (%)]a
Male xx (xx.x) xx (xx.x) xx (xx.x)
Female xx (xx.x) xx (xx.x) xx (xx.x)

Ethnicity [n (%)]a
Hispanic or Latino xx (xx.x) xx (xx.x) xx (xx.x)
Not Hispanic or Latino xx (xx.x) xx (xx.x) xx (xx.x)

Race [n (%)]a
White xx (xx.x) xx (xx.x) xx (xx.x)
Black or African American xx (xx.x) xx (xx.x) xx (xx.x)
Asian xx (xx.x) xx (xx.x) xx (xx.x)
American Indian or Alaskan Native xx (xx.x) xx (xx.x) xx (xx.x)
Native Hawaiian or Other Pacific Islander xx (xx.x) xx (xx.x) xx (xx.x)
Other xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing [Link]

a
Percentages are based on the number of subjects in the population.
Note: SD = standard deviation, Min = Minimum, Max = Maximum.
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[Link] Subject Demographics and Baseline Characteristics

Safety Population

BP3304 Placebo Overall

(N =xx) (N =xx) (N=xx)
Height (cm)
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Weight (kg)
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Body Mass Index (kg/m2)

N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Reference: Listing [Link]

Note: SD = standard deviation, Min = Minimum, Max = Maximum.
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[Link] Subject Demographics and Baseline Characteristics

Safety Population

BP3304 Placebo Overall

(N =xx) (N =xx) (N=xx)
Alcohol History [n (%)]a
Never Consumed xx (xx.x) xx (xx.x) xx (xx.x)
Previously Consumed xx (xx.x) xx (xx.x) xx (xx.x)
Currently Consumes xx (xx.x) xx (xx.x) xx (xx.x)

Tobacco History [n (%)]a

Never Consumed xx (xx.x) xx (xx.x) xx (xx.x)
Previously Consumed xx (xx.x) xx (xx.x) xx (xx.x)
Currently Consumes xx (xx.x) xx (xx.x) xx (xx.x)

Duration of Hypertension (years)

N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

<10 years xx (xx.x) xx (xx.x) xx (xx.x)

>10 years xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing [Link]

a
Percentages are based on the number of subjects in the population.
Note: SD = standard deviation, Min = Minimum, Max = Maximum.
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The following tables will be identical in format to Table [Link], but will summarize data for the MITT population.

[Link] Subject Demographics – Modified Intent-to-Treat Population

[Link] Subject Demographics – Per Protocol Population
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14.1.3 Subject Evaluability

BP3304 Placebo Overall

n (%) n (%) n (%)
Randomized xx xx xx

Safety Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Not Safety Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Did Not Receive Study Medication xx (xx.x) xx (xx.x) xx (xx.x)

MITT Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Not MITT Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Not in Safety Population xx (xx.x) xx (xx.x) xx (xx.x)
No Baseline Diastolic Blood Pressure xx (xx.x) xx (xx.x) xx (xx.x)
No Post-Baseline Diastolic Blood Pressure xx (xx.x) xx (xx.x) xx (xx.x)

Per Protocol Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Not Per Protocol Evaluable xx (xx.x) xx (xx.x) xx (xx.x)

Not in MITT Population xx (xx.x) xx (xx.x) xx (xx.x)
Received <80% of Scheduled Doses xx (xx.x) xx (xx.x) xx (xx.x)
Major Protocol Violations xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Appendices 16.2.1 and 16.2.2

Note: Percentages are based on the number of randomized subjects.
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[Link] Prior Medications

Safety Population

BP3304 Placebo Overall

Therapeutic Class (N =xx) (N =xx ) (N =xx)
Generic Name n (%) n (%) n (%)
Any Prior Medication xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class I xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class II xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing [Link]

Note: Prior medications include all recorded medications taken prior to the date of the first injection of study drug. Percentages are
based on the number of subjects in each population. Subjects taking a medication more than once are only counted once for that
medication.
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[Link] Concomitant Treatment Phase Medications

Safety Population

BP3304 Placebo Overall

Therapeutic Class (N =xx) (N =xx ) (N =xx)
Generic Name n (%) n (%) n (%)
Any Concomitant Treatment Phase Medication xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class I xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class II xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing [Link]

Note: Concomitant Treatment Phase medications include all recorded medications which were taken prior to and continue after Day 1
and those that start on or after Day 1 up until the last dose date plus 1 day, inclusive. Percentages are based on the number of subjects
in each population. Subjects taking a medication more than once are only counted once for that medication.
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[Link] Concomitant Follow-up Phase Medications

Safety Population

BP3304 Placebo Overall

Therapeutic Class (N =xx) (N =xx ) (N =xx)
Generic Name n (%) n (%) n (%)
Any Concomitant Follow-up Phase Medication xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class I xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Therapeutic Class II xx (xx.x) xx (xx.x) xx (xx.x)

Generic Term I xx (xx.x) xx (xx.x) xx (xx.x)
Generic Term II xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing [Link]

Note: Concomitant Follow-up Phase medications include all recorded medications which were taken prior to and continue after the
last dose day plus 1 and those that start after the last dose day plus 1. Percentages are based on the number of subjects in each
population. Subjects taking a medication more than once are only counted once for that medication.
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[Link] Exposure to Study Medication

Safety Population

BP3304 Placebo Overall

(N =xx) (N =xx) (N=xx)
Duration of Exposure (weeks)
N xx xx xx
Mean (SD) xx,xx ([Link]) xx,xx ([Link]) xx,xx ([Link])
Median [Link] [Link] [Link]
Min, Max xx.x, xx.x xx.x, xx.x xx.x, xx.x

Total Number of Doses Taken

N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Reference: Appendix 16.2.5

Note: Exposure to study drug in weeks is computed for each patient as the date of last dose minus the date of first dose,
plus 1 day divided by 7 days per week. SD = standard deviation, Min = Minimum, Max = Maximum.
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The following table will be identical in format to Table [Link], but will summarize data for the MITT population.

[Link] Exposure to Study Medication – Modified Intent-to-Treat Population

[Link] Exposure to Study Medication – Per Protocol Population
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[Link] Treatment Compliance

Safety Population

BP3304 Placebo Overall

(N =xx) (N =xx) (N=xx)
Compliance (%)
N xx xx xx
Mean (SD) xx,xx ([Link]) xx,xx ([Link]) xx,xx ([Link])
Median [Link] [Link] [Link]
Min, Max xx.x, xx.x xx.x, xx.x xx.x, xx.x

<80% [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)

>80% [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Appendix 16.2.5

Note: Compliance with study drug dosing is computed for each patient as the exposure to study drug in days minus the
number of Treatment Phase days on which study drug was not administered, divided by exposure to study drug in days,
multiplied by 100%. SD = standard deviation, Min = Minimum, Max = Maximum.
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The following table will be identical in format to Table [Link], but will summarize data for the MITT population.

[Link] Treatment Compliance – Modified Intent-to-Treat Population

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[Link] Diastolic Blood Pressure

Modified Intent-to-Treat Population

BP3304 (N = xx) Placebo (N = xx)

Observed Change From Baseline Observed Change From Baseline
Baseline
N XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X

Week 4
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
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[Link] Diastolic Blood Pressure

Modified Intent-to-Treat Population

BP3304 (N = xx) Placebo (N = xx)

Observed Change From Baseline Observed Change From Baseline
Week 8
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

Week 12
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
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[Link] Diastolic Blood Pressure

Modified Intent-to-Treat Population

BP3304 (N = xx) Placebo (N = xx)

Observed Change From Baseline Observed Change From Baseline
Week 16
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

Week 20
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
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[Link] Diastolic Blood Pressure

Modified Intent-to-Treat Population

BP3304 (N = xx) Placebo (N = xx)

Observed Change From Baseline Observed Change From Baseline
Week 24
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

End of Study
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
The following tables will be identical in format to Table [Link], but will summarize different parameters for different populations.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Diastolic Blood Pressure – Per Protocol Population

[Link] Systolic Blood Pressure – Modified Intent-to-Treat Population

[Link] Systolic Blood Pressure – Per Protocol Population

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Diastolic Blood Pressure by Age Group

Modified Intent-to-Treat Population
Age: >65 Years Old
BP3304 (N = xx) Placebo (N = xx)
Observed Change From Baseline Observed Change From Baseline
Baseline
N XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X

Week 4
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Diastolic Blood Pressure by Age Group

Modified Intent-to-Treat Population
Age: >65 Years Old
BP3304 (N = xx) Placebo (N = xx)
Observed Change From Baseline Observed Change From Baseline
Week 8
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

Week 12
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Diastolic Blood Pressure by Age Group

Modified Intent-to-Treat Population
Age: >65 Years Old
BP3304 (N = xx) Placebo (N = xx)
Observed Change From Baseline Observed Change From Baseline
Week 16
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

Week 20
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Diastolic Blood Pressure by Age Group

Modified Intent-to-Treat Population
Age: >65 Years Old
BP3304 (N = xx) Placebo (N = xx)
Observed Change From Baseline Observed Change From Baseline
Week 24
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)

End of Study
N XX XX XX XX
Mean (SD) [Link] ([Link]) [Link] ([Link]) [Link] ([Link]) [Link] ([Link])
Median [Link] [Link] [Link] [Link]
Min, Max XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X XXX.X, XXX.X
LS Mean (SE) XX.X ([Link]) XX.X ([Link])
95% CI for LS Mean (XX.X, XX.X) (XX.X, XX.X)
LS Mean Difference (SE) XX.X ([Link])
p-value [Link]
95% CI for LS Mean Difference (XX.X, XX.X)
Reference: Listing [Link]
Note: Baseline is defined as the last value collected before the first dose of study drug. Least squares means, standard errors, and confidence intervals
come from a last observation carried forward (LOCF) analysis using an analysis of covariance (ANCOVA) model with fixed effects for treatment and
baseline therapy strata and a covariate for baseline blood pressure.. SD = Standard Deviation, Min = Minimum, Max = Maximum LS = Least Squares,
SE = Standard Error, CI = Confidence Interval.
Repeat for Age <=65 Years Old.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

The following tables will be identical in format to Table [Link], but will summarize diastolic blood pressure for different populations and
subgroups.

[Link] Diastolic Blood Pressure by Age Group – Per Protocol Population (>65, <= 65 Years Old)

[Link] Diastolic Blood Pressure by Duration of Hypertension – Modified Intent-to-Treat Population (<10 Years, >=10 Years)

[Link] Diastolic Blood Pressure by Duration of Hypertension – Per Protocol Population (<10 Years, >=10 Years)
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Time to Achievement of Diastolic Blood Pressure ≤ 90 mmHg

Modified Intent-to-Treat Population

BP3304 Placebo
(N = xx) (N = xx)
n (%) n (%)
N xx xx
No. with DBP ≤ 90 mmHg xx (xx.x) xx (xx.x)
No. of Censored xx (xx.x) xx (xx.x)

Time to DBP ≤ 90 mmHg (Weeks)

Median [Link] [Link]
95% CI of Median ([Link], [Link]) ([Link], [Link])
25-75%ile [Link] – [Link] [Link] – [Link]
Min, Max xx.x, xx.x+ xx.x, xx.x+

Reference: Listing [Link]

Note: Time to diastolic blood pressure ≤ 90 mmHg is calculated using Kaplan-Meier methods. 95% CI for
median is computed using Brookmeyer and Crowley’s method.
+ = censored value, C.I. = Confidence interval, DBP = diastolic blood pressure.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

The following table will be identical in format to Table [Link], but will summarize data for the Per Protocol population.

[Link] Time to Achievement of Diastolic Blood Pressure ≤ 90 mmHg – Per Protocol Population
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Proportion of Patients Achieving Diastolic Blood Pressure ≤ 90 mmHg

Modified Intent-to-Treat Population

BP3304 Placebo
(N = xx) (N = xx)
n (%) n (%)
At Any Time During the Study XX/XX (XX.X) XX/XX (XX.X)

Week 20 XX/XX (XX.X) XX/XX (XX.X)

Odds Ratio Versus Placebo [Link]
95% Confidence Interval ([Link], [Link])
p-value [Link]

Week 24 XX/XX (XX.X) XX/XX (XX.X)

Odds Ratio Versus Placebo [Link]
95% Confidence Interval ([Link], [Link])
p-value [Link]

Reference: Listing [Link]

Note: Odds ratios, 95% confidence intervals, and p-values come from a logistic regression analyses will be used
with a covariate for baseline blood pressure to compare treatment groups.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

The following table will be identical in format to Table [Link], but will summarize data for the Per Protocol population.

[Link] Proportion of Patients Achieving Diastolic Blood Pressure ≤ 90 mmHg – Per Protocol Population
 Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link].1 Overall Summary of Treatment-Emergent Adverse Events

Safety Population

BP3304 Placebo Overall

(N =xx ) (N =xx ) (N =xx )
n (%) Events n (%) Events n (%) Events
Treatment-Emergent Adverse Events (TEAE)
Any TEAE xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Severe TEAE xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Any Treatment-Related TEAE xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Resulting in Study Drug Discontinuation xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Treatment-Related Resulting in Study Drug Discontinuation xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx

Any TEAE by Maximum Severity

Mild xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Moderate xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Severe xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx

Treatment-Related TEAE by Maximum Severity

Mild xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Moderate xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Severe xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx

Reference: Listing 16.2.7

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Treatment-
related TEAEs are AEs considered to be possibly or probably related to study drug. Percentages are based on the number of subjects in each population.
Subjects reporting more than one adverse event in any category are counted only once for that category.
 Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link].1 Overall Summary of Treatment-Emergent Adverse Events

Safety Population

BP3304 Placebo Overall

(N =xx ) (N =xx ) (N =xx )
n (%) Events n (%) Events n (%) Events
Serious Adverse Events (SAE)
Any SAE xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Any Treatment-Related SAE xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx

Deaths
SAE Resulting in Death xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx
Treatment-Related SAE Resulting in Death xx (xx.x) xx xx (xx.x) xx xx (xx.x) xx

Reference: Listing 16.2.7

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Treatment-
related TEAEs are AEs considered to be possibly or probably related to study drug. Percentages are based on the number of subjects in each population.
Subjects reporting more than one adverse event in any category are counted only once for that category.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link].2.1 Treatment-Emergent Adverse Events by System Organ Class

Safety Population

BP3304 Placebo Overall

System Organ Class (N =xx ) (N =xx ) (N =xx )
Preferred Term n (%) n (%) n (%)

Any Treatment-Emergent Adverse Event xx (xx.x) xx (xx.x) xx (xx.x)

System Organ Class I xx (xx.x) xx (xx.x) xx (xx.x)

Preferred Term I xx (xx.x) xx (xx.x) xx (xx.x)
Preferred Term II xx (xx.x) xx (xx.x) xx (xx.x)

System Organ Class II xx (xx.x) xx (xx.x) xx (xx.x)

Preferred Term I xx (xx.x) xx (xx.x) xx (xx.x)
Preferred Term II xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing 16.2.7

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive.
Subjects with more than one occurrence of a preferred term are counted only once.

Programming note: Terms should be sorted in descending order (based on the overall incidence) within a SOC.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

The following tables will be the same in format as Table [Link].2.1:

[Link].2.2 Treatment Related Treatment Emergent Adverse Events by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.

[Link].3.1 Severe Treatment Emergent Adverse Events by System Organ Class – Safety Population

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects
with more than one occurrence of a preferred term are counted only once.

[Link].3.2 Treatment Related Severe Treatment Emergent Adverse Events by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.

[Link].4.1 Treatment Emergent Adverse Events Reported by > 5% of BP3304 Patients by System Organ Class – Safety Population

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects
with more than one occurrence of a preferred term are counted only once.

[Link].4.2 Treatment Related Treatment Emergent Adverse Events Reported by > 5% of BP3304 Patients by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link].5.1 Treatment Emergent Adverse Events Resulting in Study Drug Discontinuation by System Organ Class – Safety Population

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects
with more than one occurrence of a preferred term are counted only once.

[Link].5.2 Treatment Related Treatment Emergent Adverse Events Resulting in Study Drug Discontinuation by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.

[Link].1 Serious Treatment Emergent Adverse Events by System Organ Class – Safety Population

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects
with more than one occurrence of a preferred term are counted only once.

[Link].2 Treatment Related Serious Treatment Emergent Adverse Events by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link].3 Treatment Emergent Adverse Events Resulting in Death by System Organ Class – Safety Population

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects
with more than one occurrence of a preferred term are counted only once.

[Link].4 Treatment Related Treatment Emergent Adverse Events Resulting in Death by System Organ Class – Safety Population

Note: Related TEAEs are AEs considered to be possibly or probably related to study drug. A treatment emergent adverse event (TEAE) will be any event that
started on or after Day 1 up until the last dose date plus 14 days, inclusive. Subjects with more than one occurrence of a preferred term are counted only once.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Treatment-Emergent Adverse Events by Maximum Severity and System Organ Class
Safety Population

BP3304 Placebo Overall

System Organ Class Maximum (N =xx ) (N =xx ) (N =xx )
Preferred Term Severity n (%) n (%) n (%)
Any Treatment Emergent Adverse Event Mild xx (xx.x) xx (xx.x) xx (xx.x)
Moderate xx (xx.x) xx (xx.x) xx (xx.x)
Severe xx (xx.x) xx (xx.x) xx (xx.x)

System Organ Class I Mild xx (xx.x) xx (xx.x) xx (xx.x)

Moderate xx (xx.x) xx (xx.x) xx (xx.x)
Severe xx (xx.x) xx (xx.x) xx (xx.x)

Preferred Term I Mild xx (xx.x) xx (xx.x) xx (xx.x)

Moderate xx (xx.x) xx (xx.x) xx (xx.x)
Severe xx (xx.x) xx (xx.x) xx (xx.x)

Preferred Term II Mild xx (xx.x) xx (xx.x) xx (xx.x)

Moderate xx (xx.x) xx (xx.x) xx (xx.x)
Severe xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Listing 16.2.7

Note: A treatment emergent adverse event (TEAE) will be any event that started on or after Day 1 up until the last dose date plus 14 days, inclusive.
Subjects with more than one occurrence of a preferred term are counted only once.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Adverse Events Resulting in Death

Safety Population

Treatment Group:
S: Severity
V: Verbatim Term Days Since Treatment A: Action
P: Preferred Term Start Date Last Study Death Date Duration Causal T: Treatment
S: System Organ Class Day* Drug Dose Day* (Days) Relationship O: Outcome

Subject Number: xxx, <Center Number>, Age: xx Years, Gender: xxxxxx, Race: xxxxx, Weight: xx.x kg, Concomitant Medication: Yes or No

Reference: CRF Pages ##, ##, and ##

* Study days are calculated from the date of the first dose of study medication.
+ Treatment-emergent adverse event.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Non-fatal Serious Adverse Events

Safety Population

Treatment Group:
S: Severity
V: Verbatim Term Days Since Treatment A: Action
P: Preferred Term Start Date Last Study Stop Date Duration Causal T: Treatment
S: System Organ Class Day* Drug Dose Day* (Days) Relationship O: Outcome

Subject Number: xxx, <Center Number>, Age: xx Years, Gender: xxxxxx, Race: xxxxx, Weight: xx.x kg, Concomitant Medication: Yes or No

Reference: CRF Pages ##, ##, and ##

* Study days are calculated from the date of the first dose of study medication.
+ Treatment-emergent adverse event.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Adverse Events Resulting in Study Discontinuation

Safety Population

Treatment Group:
S: Severity
V: Verbatim Term Days Since Treatment A: Action
P: Preferred Term Start Date Last Study Stop Date Duration Causal T: Treatment
S: System Organ Class Day* Drug Dose Day* (Days) Relationship O: Outcome Serious?

Subject Number: xxx, <Center Number>, Age: xx Years, Gender: xxxxxx, Race: xxxxx, Weight: xx.x kg, Concomitant Medication: Yes or No

Reference: CRF Pages ##, ##, and ##

* Study days are calculated from the date of the first dose of study medication.
+ Treatment-emergent adverse event.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Serum Chemistry Laboratory Parameters

Safety Population

<Blood Chemistry Parameter (Units)>

BP33404 Placebo Overall
(N=xx) (N=xx) (N=xx)
Change From Change From Change From
Visit Actual Baseline Actual Baseline Actual Baseline
Baseline
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Week 4
N xx xx xx xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx
Reference: Appendices [Link].1-[Link].4
Note: SD = standard deviation, Min = Minimum, Max = Maximum. Baseline is defined as the last value collected before the first dose of study drug.

Programming note: The number of significant digits will vary by parameter. Parameters should not be sorted alphabetically, but rather placed in logical
groups.

Repeat for Week 8, 12, 16, 20 and 24 visits.

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Hematology Laboratory Parameters

Safety Population

<Blood Chemistry Parameter (Units)>

BP33404 Placebo Overall
(N=xx) (N=xx) (N=xx)
Change From Change From Change From
Visit Actual Baseline Actual Baseline Actual Baseline
Baseline
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Week 4
N xx xx xx xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx
Reference: Appendices [Link].1-[Link].4
Note: SD = standard deviation, Min = Minimum, Max = Maximum. Baseline is defined as the last value collected before the first dose of study drug.

Programming note: The number of significant digits will vary by parameter. Parameters should not be sorted alphabetically, but rather placed in logical
groups.

Repeat for Week 8, 12, 16, 20 and 24 visits.

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Shifts from Baseline in Serum Chemistry Laboratory Parameters

Safety Population

[Laboratory Parameter Name, Unit]

BP3304 Placebo
(N=xx) (N=xx)
Baseline Baseline
Low Normal High Low Normal High
Week 4 [n (%)] (N = XX) (N = XX)
Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 8 [n (%)] (N = XX) (N = XX)

Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 12 [n (%)] (N = XX) (N = XX)

Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Reference: Listing [Link].2

Note: Baseline is defined as the last value collected before the first dose of study drug. .

Repeat for Week 16, 20 and 24 visits.

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Shifts from Baseline in Hematology Laboratory Parameters

Safety Population

[Laboratory Parameter Name, Unit]

BP3304 Placebo
(N=xx) (N=xx)
Baseline Baseline
Low Normal High Low Normal High
Week 4 [n (%)] (N = XX) (N = XX)
Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 8 [n (%)] (N = XX) (N = XX)

Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 12 [n (%)] (N = XX) (N = XX)

Low XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
High XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Reference: Listing [Link].2

Note: Baseline is defined as the last value collected before the first dose of study drug. .

Repeat for Week 16, 20 and 24 visits.

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Shifts from Baseline in Urinalysis Laboratory Parameters

Safety Population

[Laboratory Parameter Name, Unit]

BP3304 Placebo
(N=xx) (N=xx)
Baseline Baseline
Low Normal High Low Normal High
Week 4 [n (%)] (N = XX) (N = XX)
Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Abnormal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 8 [n (%)] (N = XX) (N = XX)

Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Abnormal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Week 12 [n (%)] (N = XX) (N = XX)

Normal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)
Abnormal XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X) XX (XXX.X)

Reference: Listing [Link].2

Note: Baseline is defined as the last value collected before the first dose of study drug. .

Repeat for Week 16, 20 and 24 visits. This table will be similar in structure to [Link].1 and [Link].2, but will use appropriate shift categories (such as “Normal” and
“Abnormal”) for the following parameters: Color, pH, Specific Gravity, Glucose, Protein, Ketones, Blood, and Microscopy (RBC, WBC, Epithelial Cells, Casts, and Crystals).
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Clinically Significant Laboratory Results During Treatment Phase

Safety Population

Laboratory Type BP3304 Placebo Overall

Laboratory Parameter [n (%)] (N=xx) (N=xx) (N=xx)
Chemistry
Parameter 1 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 2 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 3 XX (XX.X) XX (XX.X) XX (XX.X)
. . . .
. . . .
. . . .

Hematology
Parameter 1 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 2 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 3 XX (XX.X) XX (XX.X) XX (XX.X)
. . . .
. . . .
. . . .

Urinalysis
Parameter 1 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 2 XX (XX.X) XX (XX.X) XX (XX.X)
Parameter 3 XX (XX.X) XX (XX.X) XX (XX.X)
. . .
. . .
. . .
Reference: Listings [Link].3, [Link].2, and [Link].2
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Vital Signs

Safety Population

<Vital Signs Parameter (Units)>

BP33404 Placebo Overall
(N=xx) (N=xx) (N=xx)
Change From Change From Change From
Visit Actual Baseline Actual Baseline Actual Baseline
Baseline
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx

Week 4
N xx xx xx xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx
Reference: Listings [Link].1-[Link].4
Note: SD = standard deviation, Min = Minimum, Max = Maximum. Baseline is defined as the last measurement before the first dose of study drug.

Programming note: The number of significant digits will vary by parameter.

Repeat for Week 8, 12, 16, 20 and 24 visits. Display for heart rate, weight and body mass index.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Clinically Significant Vital Signs During Treatment Phase

Safety Population

BP3304 Placebo Overall

(N=xx) (N=xx) (N=xx)
n (%) n (%) n (%)
Diastolic Blood Pressure
<40 mmHg XX (XX.X) XX (XX.X) XX (XX.X)
>130 mmHg XX (XX.X) XX (XX.X) XX (XX.X)

Systolic Blood Pressure

<80 mmHg XX (XX.X) XX (XX.X) XX (XX.X)
>210 mmHg XX (XX.X) XX (XX.X) XX (XX.X)

Heart Rate
<40 beats per minute XX (XX.X) XX (XX.X) XX (XX.X)
>150 beats per minute XX (XX.X) XX (XX.X) XX (XX.X)

Temperature
<32 C XX (XX.X) XX (XX.X) XX (XX.X)
>40 C XX (XX.X) XX (XX.X) XX (XX.X)

Reference: Listings [Link].1-[Link].4

Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Electrocardiogram Overall Results

Safety Population

BP33404 Placebo
(N=xx) (N=xx)
n (%) of Patients N Normal Abnormal N Normal Abnormal
Screening 1 xx xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x)
Screening 2 xx xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x)
Screening 3 xx xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x)
Week 24 xx xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x)

Reference: Listing [Link]

Note: N = Number of patients with results at the indicated visit (this number is used as the denominator for computing percentages).
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Electrocardiogram Results by Parameter

Safety Population

<Electrocardiogram Parameter (Units)>

BP33404 (N=xx) Placebo (N=xx) Overall (N=xx)
Change From Change From Change From
Visit Actual Baseline Actual Baseline Actual Baseline
Baseline
N xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx
>450 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>480 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>500 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)

Week 24
N xx xx xx xx xx xx
Mean (SD) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link]) xx,x ([Link])
Median xx.x xx.x xx.x xx.x xx.x xx.x
Min, Max xx, xx xx, xx xx, xx xx, xx xx, xx xx, xx
>450 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>480 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>500 ms [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>30 ms Increase [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)
>60 ms Increase [n (%)] xx (xx.x) xx (xx.x) xx (xx.x)

Reference: Appendices [Link].1-[Link].4

Note: Baseline value is mean of 3 tracings collected during screening period. The change from baseline value is calculated using this mean baseline value. SD =
Standard Deviation, Min = Minimum, Max = Maximum.
Display for PR, QT, QTcB, QTcF, QRS, and RR intervals.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Screening Physical Examination

Safety Population

BP33404 Placebo
(N=xx) (N=xx)
Abnormal Abnormal
Body System [n (%)] N Normal NCS CS N Normal NCS CS
Body as a Whole xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Head, Eyes, Ears, Nose, Throat xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Neck/Thyroid xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Back xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Breasts/Gynecological xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Lungs xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Heart xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Skin xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Abdomen xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Extremities/Musculoskeletal xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Neurological xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Urological xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Other xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Reference: Listing 16.2.11
Note: N = Number of patients with results for the indicated body system (this number is used as the denominator for computing percentages), NCS = Not
Clinically Significant, CS = Clinically Significant.
Bigg Pharmaceutical Company Date: ddMONyyyy
BP3304-002 Program [Link]
Page X of Y

[Link] Follow-up Physical Examination

Safety Population

BP33404 Placebo
(N=xx) (N=xx)
Body System Change Change
Visit [n (%)] N No Change NCS CS N No Change NCS CS
Body as a Whole
Baseline xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 4 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 12 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 24 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Early Termination xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)

Head, Eyes, Ears, Nose, Throat

Baseline xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 4 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 12 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Week 24 xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)
Early Termination xx xx (xx.x) xx (xx.x) xx (xx.x) xx xx (xx.x) xx (xx.x) xx (xx.x)

.
.
.
Reference: Listing 16.2.11
Note: This table summarizes change from the previous visit (not change from baseline). N = Number of patients with results for the indicated body system
(this number is used as the denominator for computing percentages), NCS = Not Clinically Significant, CS = Clinically Significant.

Additional pages will show the result for each body system.