Single Dose Ranging Study of BI 1744 CL (Olodaterol) in C... | NCT01809262

Single Dose Ranging Study of BI 1744 CL (Olodaterol) in C... | NCT01809262 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
olodaterol 2 mcg	Experimental	solution for inhalation	Drug: single dose of 2 mcg
olodaterol 5 mcg	Experimental	solution for inhalation	Drug: single dose of 5 mcg
olodaterol 10 mcg	Experimental	solution for inhalation	Drug: single dose of 10 mcg
olodaterol 20 mcg	Experimental	solution for inhalation	Drug: single dose of 20 mcg
olodaterol 40 mcg	Experimental	solution for inhalation	Drug: single dose of 40 mcg
placebo	Placebo Comparator	solution for inhalation	Drug: single dose of placebo

Name	Type	Description	Arm Group Labels	Other Names
single dose of 5 mcg	Drug	solution for inhalation	olodaterol 5 mcg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment	Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.	24 hours post-dosing

Secondary Outcomes

Measure	Description	Time Frame
FEV1 AUC 0 - 3 Hours	The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.	-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg	Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Period 2 (Second Dose + Washout)

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0014 subjects FG0024 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0074 subjects FG0083 subjects FG0094 subjects
COMPLETED		FG0004 subjects FG0014 subjects FG0024 subjects FG0033 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Period 3 (Third Dose + Washout)

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0014 subjects FG0024 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0074 subjects FG0083 subjects FG0094 subjects
COMPLETED		FG0004 subjects FG0013 subjects FG0024 subjects FG0033 subjects FG004
NOT COMPLETED		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0011 subjects FG0020 subjects FG003

Period 4 (Fourth Dose + Washout)

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0013 subjects FG0024 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0074 subjects FG0083 subjects FG0094 subjects
COMPLETED		FG0004 subjects FG0013 subjects FG0024 subjects FG0033 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Period 5 (Fifth Dose + Washout)

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0013 subjects FG0024 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0074 subjects FG0083 subjects FG0094 subjects
COMPLETED		FG0004 subjects FG0013 subjects FG0024 subjects FG0033 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Study Total	Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.0± 9.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011
Male	BG00025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment

Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.

Posted

Mean

Standard Error

24 hours post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004	Olo 20 mcg	Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.

Units	Counts
Participants	OG00035 OG00135 OG00235 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.916± 0.014 OG0010.986± 0.014 OG0021.015± 0.014 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0005		Mean Difference (Final Values)	0.070	Standard Error of the Mean	0.020		95	0.031	0.109				No	Superiority or Other
OG000 OG002		ANCOVA		<0.0001

Secondary

FEV1 AUC 0 - 3 Hours

The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.

Secondary

FEV1 AUC 0 - 12 Hours

The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.

Secondary

FEV1 AUC 0 - 24 Hours

The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.

Secondary

FEV1 AUC 12 - 24 Hours

The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

12h, 14h, 22h, 23h and 24h post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.

Secondary

Peak FEV1 From 0 to 3 Hours

Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

0 to 3 hours post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004	Olo 20 mcg	Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.

Secondary

Peak Forced Vital Capacity (FVC) From 0 to 3 Hours

Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint

Posted

Mean

Standard Error

0 to 3 hours post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004	Olo 20 mcg

Secondary

Time to Peak Bronchodilator Response

A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.

Posted

Mean

Standard Deviation

minutes

0 to 3 hours post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004

Secondary

Time to Onset of Response

Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.

Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.

Posted

Mean

Standard Deviation

minutes

0 to 3 hours post-dosing

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg

Secondary

Number of Patients Requiring Rescue Medication on a Test-day

Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.

Safety set which consisted of all randomised patients who had taken at least one dose of study medication.

Posted

Number

Number of Patients

Visits 1,2,4,5,6

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.

Secondary

Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).

Safety set

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004	Olo 20 mcg

Secondary

Laboratory Testing: Average Change From Baseline of Potassium and Calcium

Laboratory testing: Average change from baseline of potassium and calcium measured on test-days

Safety set.

Posted

Geometric Mean

Inter-Quartile Range

mmol/L

Baseline and Visit 6

ID	Title	Description
OG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.
OG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
OG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
OG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
OG004	Olo 20 mcg	Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Single dose of matching placebo delivered by the Respimat inhaler.	1	35	5	35
EG001	Olo 2 mcg	Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.	1	35	2	35
EG002	Olo 5 mcg	Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.	2	35	4	35
EG003	Olo 10 mcg	Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.	0	34	5	34
EG004	Olo 20 mcg	Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.	0	35	4	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected35 at risk EG0022 affected35 at risk EG0030 affected34 at risk EG004
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected35 at risk EG0020 affected35 at risk EG003
Perineal abscess	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected35 at risk EG0020 affected35 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0003 affected35 at risk EG0010 affected35 at risk EG0021 affected35 at risk EG0031 affected34 at risk EG0041 affected35 at risk
Respiratory tract infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected35 at risk EG0020 affected35 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected35 at risk EG0022 affected35 at risk EG003
Headache	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected35 at risk EG0020 affected35 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected35 at risk EG0021 affected35 at risk EG003

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.108	Standard Error of the Mean	0.016	95	0.077	0.139	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.155	Standard Error of the Mean	0.016	95	0.124	0.186	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.161	Standard Error of the Mean	0.016	95	0.130	0.192	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.192	Standard Error of the Mean	0.016	95	0.161	0.223	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.099	Standard Error of the Mean	0.016	95	0.068	0.131	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.139	Standard Error of the Mean	0.016	95	0.107	0.171	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.153	Standard Error of the Mean	0.016	95	0.122	0.185	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.184	Standard Error of the Mean	0.016	95	0.152	0.215	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.087	Standard Error of the Mean	0.015	95	0.056	0.117	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.118	Standard Error of the Mean	0.015	95	0.087	0.148	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.138	Standard Error of the Mean	0.015	95	0.107	0.168	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.162	Standard Error of the Mean	0.015	95	0.132	0.193	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.074	Standard Error of the Mean	0.017	95	0.041	0.108	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.096	Standard Error of the Mean	0.017	95	0.062	0.130	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.122	Standard Error of the Mean	0.017	95	0.089	0.156	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.141	Standard Error of the Mean	0.017	95	0.107	0.174	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.121	Standard Error of the Mean	0.019	95	0.084	0.158	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.166	Standard Error of the Mean	0.019	95	0.129	0.203	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.176	Standard Error of the Mean	0.019	95	0.139	0.214	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.213	Standard Error of the Mean	0.019	95	0.176	0.250	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	<0.0001	Mean Difference (Final Values)	0.306	Standard Error of the Mean	0.049	95	0.210	0.402	No	Superiority or Other
OG000 OG002	ANCOVA	<0.0001	Mean Difference (Final Values)	0.355	Standard Error of the Mean	0.049	95	0.258	0.452	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Mean Difference (Final Values)	0.350	Standard Error of the Mean	0.049	95	0.253	0.447	No	Superiority or Other
OG000 OG004	ANCOVA	<0.0001	Mean Difference (Final Values)	0.455	Standard Error of the Mean	0.049	95	0.359	0.551	No	Superiority or Other

Title

Denominators

Categories

Potassium (N=17, 18, 17, 17, 18)

Title	Measurements
	OG0001.03± NA(0.99 to 1.07) OG0011.01± NA(0.98 to 1.03) OG0020.99± NA(0.95 to 1.03) OG0030.98± NA(0.97 to 1.02) OG0040.97± NA(0.92 to 1.01)

Calcium (N=18, 18, 17, 17, 18)

Title	Measurements
	OG0001.02± NA(0.99 to 1.03) OG0011.00± NA(0.99 to 1.03) OG0021.00± NA(0.98 to 1.01) OG003