Trial Outcomes & Findings for Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study (NCT NCT01934192)

NCT ID: NCT01934192

Last Updated: 2017-12-11

Results Overview

The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 91 participants
• Primary outcome timeframe: Up to Day 7
• Results posted on: 2017-12-11

Participant Flow

A total of 92 participants between 18 to 85 years of age who were admitted to Intensive Care Unit (ICU), mechanically ventilated and who received enteral nutrition (EN) were included in this study.

The study consisted of a screening phase, a treatment period of up to 7 days and a post treatment safety follow-up of 14 days after the last dose of study medication. After performing Baseline tests eligible participants were included in the study.

Participant milestones

Measure	Baseline EN Tolerant: Placebo/Camicinal Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.	Baseline EN Tolerant: Camicinal/Metoclopramide Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.	Baseline EN Intolerant: Camicinal Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.	Baseline EN Intolerant: Metoclopramide Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
Overall Study STARTED	40	44	4	4
Overall Study COMPLETED	31	37	3	3
Overall Study NOT COMPLETED	9	7	1	1

Reasons for withdrawal

Measure	Baseline EN Tolerant: Placebo/Camicinal Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.	Baseline EN Tolerant: Camicinal/Metoclopramide Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.	Baseline EN Intolerant: Camicinal Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.	Baseline EN Intolerant: Metoclopramide Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
Overall Study Protocol Violation	0	0	0	1
Overall Study Other: reached stopping criteria	6	5	1	0
Overall Study Physician Decision	3	2	0	0

Baseline Characteristics

Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study

Baseline characteristics by cohort

Measure	Baseline EN Tolerant: Placebo/Camicinal n=40 Participants Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.	Baseline EN Tolerant: Camicinal/Metoclopramide n=44 Participants Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.	Baseline EN Intolerant: Camicinal n=4 Participants Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.	Baseline EN Intolerant: Metoclopramide n=4 Participants Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.	Total n=92 Participants Total of all reporting groups
Age, Continuous	55.1 Years STANDARD_DEVIATION 15.93 • n=5 Participants	59.8 Years STANDARD_DEVIATION 16.64 • n=7 Participants	64.3 Years STANDARD_DEVIATION 13.40 • n=5 Participants	45.5 Years STANDARD_DEVIATION 9.68 • n=4 Participants	57.3 Years STANDARD_DEVIATION 16.19 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	27 Participants n=21 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	32 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	65 Participants n=21 Participants
Race/Ethnicity, Customized Race, Customized · American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race, Customized · Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race, Customized · White - White/Caucasian/European Heritage	40 Participants n=5 Participants	42 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	90 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 7

Population: Intension To Treat \[ITT (exposed)\] Population. ITT (exposed) Population comprised of all randomized participants who received at least of one dose of study treatment.

The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population	76.6 Percentage of goal volume Interval 67.0 to 86.3	67.7 Percentage of goal volume Interval 57.6 to 77.8	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 7

Population: Per Protocol (PP) Population. PP Population comprised of all randomized participants who receive at least two doses of study treatment and have at least two days of evaluable nutritional data and also comply with the protocol.

The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

Outcome measures

Measure	Camicinal 50 mg n=34 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=32 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population	76.6 Percentage of goal volume Interval 70.6 to 82.7	74.4 Percentage of goal volume Interval 68.2 to 80.6	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population

The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Average Percentage Goal Calories Delivered Prior to Development of Intolerance	76.7 Percentage of goal calories Interval 67.0 to 86.3	67.8 Percentage of goal calories Interval 57.6 to 77.9	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population

The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Average Percentage Goal Protein Delivered Prior to Development of Intolerance	76.3 Percentage of goal protein Interval 67.0 to 85.5	69.8 Percentage of goal protein Interval 60.0 to 79.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population

Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance	2.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 3.0	—	—	—	—

SECONDARY outcome

Timeframe: up to 23 days

Population: Safety Population. Safety Population comprised of all participants who received at least one dose one study treatment.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AE	9 Participants	13 Participants	2 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day6; n= 0,0,2,1,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	14.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-3.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	7.3 millimeter of mercury (mmHg) Standard Deviation 4.62	13.7 millimeter of mercury (mmHg) Standard Deviation 25.97
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day1; n= 23,33,1,3,0,0	-4.6 millimeter of mercury (mmHg) Standard Deviation 19.58	1.0 millimeter of mercury (mmHg) Standard Deviation 24.37	1.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	3.0 millimeter of mercury (mmHg) Standard Deviation 23.64	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day2; n= 33,38,2,2,0,0	3.7 millimeter of mercury (mmHg) Standard Deviation 22.66	1.4 millimeter of mercury (mmHg) Standard Deviation 23.55	12.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	16.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day3; n= 29,31,1,1,0,0	5.1 millimeter of mercury (mmHg) Standard Deviation 28.06	4.9 millimeter of mercury (mmHg) Standard Deviation 25.00	6.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-16.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP follow up; n= 27,28,3,3,4,2	-0.6 millimeter of mercury (mmHg) Standard Deviation 25.75	-1.4 millimeter of mercury (mmHg) Standard Deviation 30.61	26.0 millimeter of mercury (mmHg) Standard Deviation 17.58	3.0 millimeter of mercury (mmHg) Standard Deviation 28.51	11.8 millimeter of mercury (mmHg) Standard Deviation 18.14	14.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day4; n=25,27,0,0,0,0	2.9 millimeter of mercury (mmHg) Standard Deviation 15.03	3.2 millimeter of mercury (mmHg) Standard Deviation 13.37	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day5; n= 22,23,0,0,0,0	5.3 millimeter of mercury (mmHg) Standard Deviation 16.12	-0.7 millimeter of mercury (mmHg) Standard Deviation 15.66	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day1; n= 23,33,1,3,0,0	-1.1 millimeter of mercury (mmHg) Standard Deviation 10.51	-1.0 millimeter of mercury (mmHg) Standard Deviation 9.84	5.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-2.0 millimeter of mercury (mmHg) Standard Deviation 13.89	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day2; n= 33,38,2,2,0,0	2.7 millimeter of mercury (mmHg) Standard Deviation 12.77	-0.2 millimeter of mercury (mmHg) Standard Deviation 11.66	-1.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	6.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day3; n= 29,31,1,1,0,0	2.2 millimeter of mercury (mmHg) Standard Deviation 12.12	1.7 millimeter of mercury (mmHg) Standard Deviation 10.44	5.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-16.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day6; n= 18,19,0,0,0,0	2.6 millimeter of mercury (mmHg) Standard Deviation 17.03	2.3 millimeter of mercury (mmHg) Standard Deviation 15.86	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Day7; n= 14,14,0,0,0,0	-4.6 millimeter of mercury (mmHg) Standard Deviation 15.33	-2.4 millimeter of mercury (mmHg) Standard Deviation 13.89	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day1; n=1,0,3,3,3,3	7.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	9.3 millimeter of mercury (mmHg) Standard Deviation 4.04	-0.3 millimeter of mercury (mmHg) Standard Deviation 11.27	11.0 millimeter of mercury (mmHg) Standard Deviation 7.81	0.0 millimeter of mercury (mmHg) Standard Deviation 14.42
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day2; n=0,0,2,3,4,4	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	4.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-12.0 millimeter of mercury (mmHg) Standard Deviation 6.24	23.5 millimeter of mercury (mmHg) Standard Deviation 17.71	-4.0 millimeter of mercury (mmHg) Standard Deviation 15.08
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day3; n= 0,0,2,3,3,4	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	10.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	6.3 millimeter of mercury (mmHg) Standard Deviation 9.07	4.3 millimeter of mercury (mmHg) Standard Deviation 8.39	-0.5 millimeter of mercury (mmHg) Standard Deviation 4.36
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day4; n= 0,0,2,2,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	9.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	15.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	11.7 millimeter of mercury (mmHg) Standard Deviation 8.50	-1.7 millimeter of mercury (mmHg) Standard Deviation 9.24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day5; n= 0,0,2,1,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-5.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	2.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	5.3 millimeter of mercury (mmHg) Standard Deviation 4.51	1.7 millimeter of mercury (mmHg) Standard Deviation 18.50
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Intolerance Day7; n= 0,0,0,0,3,2	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	7.7 millimeter of mercury (mmHg) Standard Deviation 7.51	8.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP Follow up; n= 27,28,3,3,4,2	9.1 millimeter of mercury (mmHg) Standard Deviation 20.14	6.7 millimeter of mercury (mmHg) Standard Deviation 13.70	23.0 millimeter of mercury (mmHg) Standard Deviation 6.08	18.0 millimeter of mercury (mmHg) Standard Deviation 4.58	4.0 millimeter of mercury (mmHg) Standard Deviation 6.98	29.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day4; n= 25,27,0,0,0,0	7.6 millimeter of mercury (mmHg) Standard Deviation 21.76	6.0 millimeter of mercury (mmHg) Standard Deviation 30.02	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day5; n= 22,23,0,0,0,0	11.3 millimeter of mercury (mmHg) Standard Deviation 27.16	-0.6 millimeter of mercury (mmHg) Standard Deviation 34.31	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day6; n= 18,19,0,0,0,0	-1.6 millimeter of mercury (mmHg) Standard Deviation 34.29	-4.2 millimeter of mercury (mmHg) Standard Deviation 33.26	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Day7; n= 14,14,0,0,0,0	-2.5 millimeter of mercury (mmHg) Standard Deviation 37.96	-5.4 millimeter of mercury (mmHg) Standard Deviation 24.47	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day1; n= 1,0,3,3,3,3	-2.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	16.3 millimeter of mercury (mmHg) Standard Deviation 12.66	1.7 millimeter of mercury (mmHg) Standard Deviation 11.50	1.0 millimeter of mercury (mmHg) Standard Deviation 13.08	-4.7 millimeter of mercury (mmHg) Standard Deviation 9.07
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day2; n= 0,0,2,3,4,4	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	4.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	-9.3 millimeter of mercury (mmHg) Standard Deviation 10.60	32.8 millimeter of mercury (mmHg) Standard Deviation 31.06	-4.0 millimeter of mercury (mmHg) Standard Deviation 7.79
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day3; n= 0,0,2,3,3,4	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	11.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	16.3 millimeter of mercury (mmHg) Standard Deviation 22.37	30.7 millimeter of mercury (mmHg) Standard Deviation 12.22	13.0 millimeter of mercury (mmHg) Standard Deviation 21.18
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day4; n= 0,0,2,2,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	19.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	22.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	43.0 millimeter of mercury (mmHg) Standard Deviation 16.52	-9.0 millimeter of mercury (mmHg) Standard Deviation 12.29
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day5; n= 0,0,2,1,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	17.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	15.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	19.7 millimeter of mercury (mmHg) Standard Deviation 24.79	8.7 millimeter of mercury (mmHg) Standard Deviation 7.02
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day6; n= 0,0,2,1,3,3	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	46.5 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	5.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	20.3 millimeter of mercury (mmHg) Standard Deviation 21.73	10.7 millimeter of mercury (mmHg) Standard Deviation 10.41
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP Intolerance Day7; n= 0,0,0,0,3,2	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	NA millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.	22.0 millimeter of mercury (mmHg) Standard Deviation 11.36	13.0 millimeter of mercury (mmHg) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Heart Rate (HR) HR Day2; n= 34,38,2,2,0,0	-1.6 beats per minute (bpm) Standard Deviation 15.23	-0.5 beats per minute (bpm) Standard Deviation 14.61	4.5 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	5.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR Day3; n= 29,31, 1,1,0,0	-0.0 beats per minute (bpm) Standard Deviation 19.68	1.6 beats per minute (bpm) Standard Deviation 12.93	26.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-21.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR intolerance Day2; n= 0,0,2,3,4,4	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	22.5 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-12.7 beats per minute (bpm) Standard Deviation 16.62	9.0 beats per minute (bpm) Standard Deviation 17.47	7.5 beats per minute (bpm) Standard Deviation 11.90
Change From Baseline in Heart Rate (HR) HR Day1; n= 23,33,1,3,0,0	-4.0 beats per minute (bpm) Standard Deviation 10.05	4.3 beats per minute (bpm) Standard Deviation 14.13	-5.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-0.7 beats per minute (bpm) Standard Deviation 11.50	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR Day4; n= 25,27,0,0,0,0	-4.4 beats per minute (bpm) Standard Deviation 19.84	2.1 beats per minute (bpm) Standard Deviation 14.96	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR Day5; n= 22,23,0,0,0,0	-3.0 beats per minute (bpm) Standard Deviation 19.21	0.2 beats per minute (bpm) Standard Deviation 17.17	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR Day6; n= 18,19,0,0,0,0	-1.2 beats per minute (bpm) Standard Deviation 22.26	1.4 beats per minute (bpm) Standard Deviation 19.46	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR Day7; n= 14,14,,0,0,0,0	-1.9 beats per minute (bpm) Standard Deviation 19.17	0.6 beats per minute (bpm) Standard Deviation 22.85	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR intolerance Day1; n= 1,0,3,3,3,3	6.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	19.7 beats per minute (bpm) Standard Deviation 8.08	-2.0 beats per minute (bpm) Standard Deviation 13.89	1.3 beats per minute (bpm) Standard Deviation 13.61	2.3 beats per minute (bpm) Standard Deviation 2.52
Change From Baseline in Heart Rate (HR) HR intolerance Day3; n= 0,0,2,3,3,4	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	8.5 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	0.7 beats per minute (bpm) Standard Deviation 12.50	6.3 beats per minute (bpm) Standard Deviation 11.93	13.5 beats per minute (bpm) Standard Deviation 12.48
Change From Baseline in Heart Rate (HR) HR intolerance Day4; n= 0,0,2,2,3,3	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	15.5 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-2.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	14.0 beats per minute (bpm) Standard Deviation 19.47	5.3 beats per minute (bpm) Standard Deviation 3.21
Change From Baseline in Heart Rate (HR) HR intolerance Day5; n= 0,0,2,1,3,3	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	9.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-3.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	19.0 beats per minute (bpm) Standard Deviation 29.87	17.3 beats per minute (bpm) Standard Deviation 16.17
Change From Baseline in Heart Rate (HR) HR intolerance Day6; n= 0,0,2,1,3,3	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	4.5 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	-1.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	19.7 beats per minute (bpm) Standard Deviation 22.85	17.0 beats per minute (bpm) Standard Deviation 11.53
Change From Baseline in Heart Rate (HR) HR intolerance Day7; n= 0,0,0,0,3,2	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	NA beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.	16.3 beats per minute (bpm) Standard Deviation 20.50	16.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Heart Rate (HR) HR follow up; n= 27,28,3,3,4,2	0.8 beats per minute (bpm) Standard Deviation 19.76	2.7 beats per minute (bpm) Standard Deviation 25.05	11.0 beats per minute (bpm) Standard Deviation 15.87	-2.0 beats per minute (bpm) Standard Deviation 19.08	16.8 beats per minute (bpm) Standard Deviation 21.73	27.0 beats per minute (bpm) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTc; <=60; n= 5,5,0,0,0,0	5 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTcF; >60; n= 11,14,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTcB; <=60; n= 11,14,0,0,0,0	11 Participants	14 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTc <= 60; n= 10,5,0,1,0,0	10 Participants	5 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTc >60; n= 10,5,0,1,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTcB <=60; n= 23,28,3,2,0,0	23 Participants	27 Participants	3 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTcB >60; n= 23,28,3,2,0,0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTcF <=60; n= 23,28,3,2,0,0	23 Participants	27 Participants	3 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 1; QTcF >60; n= 23,28,3,2,0,0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTc <= 60; n= 8,7,0,1,0,0	8 Participants	7 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTc >60; n= 8,7,0,1,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTcB <=60; n= 23,28,2,1,0,0	23 Participants	26 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTcB >60; n= 23,28,2,1,0,0	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTcF <=60; n= 23,28,2,1,0,0	23 Participants	27 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 2; QTcF >60; n= 23,28,2,1,0,0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTc <= 60; n= 7,6,0,1,0,0	7 Participants	6 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTc >60; n= 7,6,0,1,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTcB <=60; n= 19,21,1,0,0	18 Participants	21 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTcB >60; n= 19,21,1,0,0	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTcF; <=60; n= 19,21,1,0,0,0	19 Participants	21 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 3; QTcF; >60; n= 19,21,1,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTc; <=60; n= 7,5,0,0,0,0	7 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTc; >60; n= 7,5,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTcB; <=60; n= 16,19,0,0,0,0	16 Participants	19 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTcB; >60; n= 16,19,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTcF; <=60; n= 16,19,0,0,0,0	16 Participants	19 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 4; QTcF; >60; n= 16,19,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTc; <=60; n= 7,5,0,0,0,0	7 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTc; >60; n= 7,5,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTcB; <=60; n= 14,17,0,0,0,0	14 Participants	17 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTcB; >60; n= 14,17,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTcF; <=60; n= 14,17,0,0,0,0	14 Participants	16 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 5; QTcF; >60; n= 14,17,0,0,0,0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTc; >60; n= 5,5,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTcB; >60; n= 11,14,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 6; QTcF; <=60; n= 11,14,0,0,0,0	11 Participants	14 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTc; <=60; n= 5,4,0,0,0,0	5 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTc; >60; n= 5,4,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTcB; <=60; n= 8,11,0,0,0,0	8 Participants	11 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTcB; >60; n= 8,11,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTcF; <=60; n= 8,11,0,0,0,0	8 Participants	11 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Day 7; QTcF; >60; n= 8,11,0,0,0,0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTc; <=60; n= 6,4,0,1,1,1	6 Participants	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTc; >60; n= 6,4,0,1,1,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTcB; <=60; n= 10,13,2,2,3,1	9 Participants	13 Participants	2 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTcB; >60; n= 10,13,2,2,3,1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTcF;<=60; n= 10,13,2,2,2,1	9 Participants	13 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Follow up; QTcF; >60; n= 10,13,2,2,2,1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Albumin and Total Protein Levels Total protein intolerance Day 2; n= 0,0,0,0,0,1	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	7.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin follow up; n= 18,17,3,3,4,2	5.81 Gram per liter (g/L) Standard Deviation 5.827	4.59 Gram per liter (g/L) Standard Deviation 6.526	4.73 Gram per liter (g/L) Standard Deviation 5.139	8.33 Gram per liter (g/L) Standard Deviation 3.512	5.25 Gram per liter (g/L) Standard Deviation 4.500	2.30 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein Day 2; n= 0,1,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-3.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein Day 3; n= 0,1,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	9.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein Day 5; n= 0,2,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	7.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein Day 6; n= 0,1,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-2.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein Day 7; n= 10,11,0,0,0,0	10.06 Gram per liter (g/L) Standard Deviation 9.663	3.21 Gram per liter (g/L) Standard Deviation 4.733	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein intolerance Day 3; n= 0,0,0,1,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	6.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein intolerance Day 4; n= 0,0,0,1,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	14.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein intolerance Day 6; n= 0,0,1,1,1,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	22.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	8.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	2.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein intolerance Day 7; n= 0,0,1,0,1,2	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	4.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	2.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	10.75 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Total protein follow up; n= 15,16,3,3,4,2	16.27 Gram per liter (g/L) Standard Deviation 13.598	16.43 Gram per liter (g/L) Standard Deviation 10.423	20.77 Gram per liter (g/L) Standard Deviation 2.250	22.33 Gram per liter (g/L) Standard Deviation 7.234	4.50 Gram per liter (g/L) Standard Deviation 17.540	18.60 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin Day 4; n= 0,1,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-3.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin Day 5; n= 0,2,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	0.50 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin Day 2; n=1,1,0,0,0,0	4.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-1.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin; Day 3; n= 0,2,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-3.50 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin Day 6; n= 0,1,0,0,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-4.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin Day 7; n= 13,11,0,0,0,0	0.98 Gram per liter (g/L) Standard Deviation 6.202	0.64 Gram per liter (g/L) Standard Deviation 6.795	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin intolerance Day 2; n= 0,0,0,0,0,1	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	7.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin intolerance Day 3; n= 0,0,0,1,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-3.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin intolerance Day 4; n= 0,0,0,1,0,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	7.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin intolerance Day 6; n= 0,0,1,1,1,0	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	3.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-3.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	11.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Albumin and Total Protein Levels Albumin intolerance Day 7; n= 0,0,1,0,2,2	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	-6.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	NA Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	0.00 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.	1.20 Gram per liter (g/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. Day 2; n= 32,34,2,2,0,0	2.7 International Unit per liter (IU/L) Standard Deviation 19.60	7.9 International Unit per liter (IU/L) Standard Deviation 19.39	2.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-2.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALk. phosp. Day 3; n= 28,28,1,1,0,0	-1.5 International Unit per liter (IU/L) Standard Deviation 42.47	21.5 International Unit per liter (IU/L) Standard Deviation 27.98	43.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	19.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. Day 4; n= 25,25,0,0,0,0	11.2 International Unit per liter (IU/L) Standard Deviation 24.62	25.4 International Unit per liter (IU/L) Standard Deviation 38.55	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phsp Day5; n= 22,23,0,0,0,0	14.2 International Unit per liter (IU/L) Standard Deviation 33.14	36.6 International Unit per liter (IU/L) Standard Deviation 49.26	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phsp Day6; n= 18,19,0,0,0,0	13.4 International Unit per liter (IU/L) Standard Deviation 36.49	53.6 International Unit per liter (IU/L) Standard Deviation 78.10	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phsp. Day7; n= 14,13,0,0,0,0	13.9 International Unit per liter (IU/L) Standard Deviation 33.93	74.6 International Unit per liter (IU/L) Standard Deviation 93.12	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0	24.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	38.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	11.7 International Unit per liter (IU/L) Standard Deviation 14.19	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	37.7 International Unit per liter (IU/L) Standard Deviation 37.55	20.0 International Unit per liter (IU/L) Standard Deviation 10.44	5.8 International Unit per liter (IU/L) Standard Deviation 13.10	18.0 International Unit per liter (IU/L) Standard Deviation 35.13
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	22.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	23.0 International Unit per liter (IU/L) Standard Deviation 17.69	-5.0 International Unit per liter (IU/L) Standard Deviation 21.07	39.3 International Unit per liter (IU/L) Standard Deviation 38.34
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	47.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	56.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	2.3 International Unit per liter (IU/L) Standard Deviation 23.07	56.0 International Unit per liter (IU/L) Standard Deviation 45.13
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	46.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	67.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	35.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	81.3 International Unit per liter (IU/L) Standard Deviation 16.56
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	51.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	56.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	29.7 International Unit per liter (IU/L) Standard Deviation 46.82	53.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	76.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	25.0 International Unit per liter (IU/L) Standard Deviation 47.16	65.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels Alk.phosp. follow up; n= 17,20,3,2,4,2	32.4 International Unit per liter (IU/L) Standard Deviation 85.80	76.0 International Unit per liter (IU/L) Standard Deviation 147.05	274.0 International Unit per liter (IU/L) Standard Deviation 272.24	71.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	77.5 International Unit per liter (IU/L) Standard Deviation 86.03	110.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 2; n= 32,35,2,2,0,0	-1.9 International Unit per liter (IU/L) Standard Deviation 16.07	2.0 International Unit per liter (IU/L) Standard Deviation 16.53	-19.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-1.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 3; n= 29,30,1,1,0,0	-2.8 International Unit per liter (IU/L) Standard Deviation 37.00	7.2 International Unit per liter (IU/L) Standard Deviation 27.49	6.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	8.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 4; n= 25,25,0,0,0,0	-4.0 International Unit per liter (IU/L) Standard Deviation 53.27	7.0 International Unit per liter (IU/L) Standard Deviation 29.81	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 5; n= 22,23,0,0,0,0	0.4 International Unit per liter (IU/L) Standard Deviation 70.15	6.7 International Unit per liter (IU/L) Standard Deviation 34.80	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 6; n= 18,19,0,0,0,0	0.1 International Unit per liter (IU/L) Standard Deviation 84.99	8.5 International Unit per liter (IU/L) Standard Deviation 44.37	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT Day 7; n= 14,13,0,0,0,0	-5.4 International Unit per liter (IU/L) Standard Deviation 95.92	14.8 International Unit per liter (IU/L) Standard Deviation 75.08	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 1; n= 1,0,2,3,0,0	1.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-2.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	9.3 International Unit per liter (IU/L) Standard Deviation 15.50	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 2; n= 0,0,3,3,4,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-25.3 International Unit per liter (IU/L) Standard Deviation 38.37	14.0 International Unit per liter (IU/L) Standard Deviation 7.55	6.5 International Unit per liter (IU/L) Standard Deviation 9.47	28.3 International Unit per liter (IU/L) Standard Deviation 61.24
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 3; n= n= 0,0,2,3,3,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-68.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	14.3 International Unit per liter (IU/L) Standard Deviation 9.61	8.3 International Unit per liter (IU/L) Standard Deviation 10.50	34.5 International Unit per liter (IU/L) Standard Deviation 55.70
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 4; n= 0,0,2,2,3,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-77.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	41.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	24.3 International Unit per liter (IU/L) Standard Deviation 30.09	118.3 International Unit per liter (IU/L) Standard Deviation 65.55
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 5; n= 0,0,2,1,3,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-81.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	50.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	34.0 International Unit per liter (IU/L) Standard Deviation 47.66	193.7 International Unit per liter (IU/L) Standard Deviation 59.58
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 6; n= 0,0,2,1,3,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-75.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	45.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	44.3 International Unit per liter (IU/L) Standard Deviation 57.87	189.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT intolerance Day 7; n= 0,0,1,0,3,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-20.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	35.3 International Unit per liter (IU/L) Standard Deviation 49.17	136.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels ALT follow up; n= n= 18,20,3,3,4,2	-4.6 International Unit per liter (IU/L) Standard Deviation 93.05	29.2 International Unit per liter (IU/L) Standard Deviation 62.61	-59.7 International Unit per liter (IU/L) Standard Deviation 68.73	50.7 International Unit per liter (IU/L) Standard Deviation 62.74	58.8 International Unit per liter (IU/L) Standard Deviation 56.20	29.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day 2; n= 31,34,2,1,0,0	-8.742 International Unit per liter (IU/L) Standard Deviation 40.5873	0.118 International Unit per liter (IU/L) Standard Deviation 23.3936	-36.500 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-9.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day3; n= 28,29,1,1,0,0	-11.500 International Unit per liter (IU/L) Standard Deviation 65.8598	-4.828 International Unit per liter (IU/L) Standard Deviation 39.6260	-18.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	16.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day4; n= 23,23,0,0,0,0	-14.348 International Unit per liter (IU/L) Standard Deviation 83.2317	-14.870 International Unit per liter (IU/L) Standard Deviation 60.7329	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day5; n= 22,22,0,0,0,0	-11.518 International Unit per liter (IU/L) Standard Deviation 88.6693	-14.318 International Unit per liter (IU/L) Standard Deviation 66.3672	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day6; n= 18,18,0,0,0,0	-18.222 International Unit per liter (IU/L) Standard Deviation 99.4494	-10.944 International Unit per liter (IU/L) Standard Deviation 75.4262	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST Day7; n= 13,12,0,0,0,0	-29.538 International Unit per liter (IU/L) Standard Deviation 115.0454	-11.417 International Unit per liter (IU/L) Standard Deviation 104.7147	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day1; n= 1,0,2,1,0,0	-11.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-50.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	1.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day2; n= 0,0,3,1,4,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-69.000 International Unit per liter (IU/L) Standard Deviation 19.0000	28.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	8.500 International Unit per liter (IU/L) Standard Deviation 15.1548	6.000 International Unit per liter (IU/L) Standard Deviation 8.0829
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day3; n= 0,0,2,2,3,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-96.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	22.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	0.333 International Unit per liter (IU/L) Standard Deviation 2.0817	20.250 International Unit per liter (IU/L) Standard Deviation 16.8795
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day4; n= 0,0,1,2,3,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-66.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	49.500 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	22.000 International Unit per liter (IU/L) Standard Deviation 32.1870	126.333 International Unit per liter (IU/L) Standard Deviation 91.1939
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day5; n= 0,0,1,1,3,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-63.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	46.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	19.000 International Unit per liter (IU/L) Standard Deviation 27.0555	281.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day6; n= 0,0,1,1,3,1	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-46.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	30.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	18.667 International Unit per liter (IU/L) Standard Deviation 17.4738	374.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST intolerance Day7; n= 0,0,1,0,3,1	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-64.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	-0.333 International Unit per liter (IU/L) Standard Deviation 10.0167	171.000 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels AST follow up; n= 17,20,3,2,4,2	-33.412 International Unit per liter (IU/L) Standard Deviation 99.3511	4.500 International Unit per liter (IU/L) Standard Deviation 82.3551	-110.333 International Unit per liter (IU/L) Standard Deviation 24.7049	8.500 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	47.000 International Unit per liter (IU/L) Standard Deviation 81.5475	-3.500 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day2; n= 32,34,2,2,0,0	7.4 International Unit per liter (IU/L) Standard Deviation 38.77	19.3 International Unit per liter (IU/L) Standard Deviation 41.39	5.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	8.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day3; n= 28,28,1,1,0,0	13.4 International Unit per liter (IU/L) Standard Deviation 95.74	49.8 International Unit per liter (IU/L) Standard Deviation 62.30	75.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	74.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day4; n= 24,24,0,0,0,0	54.8 International Unit per liter (IU/L) Standard Deviation 77.91	51.0 International Unit per liter (IU/L) Standard Deviation 52.82	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day5; n= 22,22,0,0,0,0	81.7 International Unit per liter (IU/L) Standard Deviation 106.54	82.1 International Unit per liter (IU/L) Standard Deviation 83.82	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day6; n= 18,18,0,0,0,0	100.1 International Unit per liter (IU/L) Standard Deviation 150.79	100.3 International Unit per liter (IU/L) Standard Deviation 104.52	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT Day7; n= 14,12,0,0,0,0	85.6 International Unit per liter (IU/L) Standard Deviation 99.69	156.0 International Unit per liter (IU/L) Standard Deviation 156.59	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day1; n= 1,0,2,3,0,0	43.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	66.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	41.7 International Unit per liter (IU/L) Standard Deviation 52.37	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day2; n= 0,0,3,3,3,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	51.0 International Unit per liter (IU/L) Standard Deviation 34.18	59.0 International Unit per liter (IU/L) Standard Deviation 47.57	21.0 International Unit per liter (IU/L) Standard Deviation 11.79	25.3 International Unit per liter (IU/L) Standard Deviation 41.42
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day3; n= 0,0,2,3,2,4	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	46.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	89.0 International Unit per liter (IU/L) Standard Deviation 73.08	28.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	65.5 International Unit per liter (IU/L) Standard Deviation 86.38
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day4; n= 0,0,2,2,2,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	153.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	216.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	45.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	196.7 International Unit per liter (IU/L) Standard Deviation 129.53
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day5; n= 0,0,2,1,2,3	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	201.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	223.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	82.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	269.3 International Unit per liter (IU/L) Standard Deviation 60.07
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day6; n= 0,0,2,1,2,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	249.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	218.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	116.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	399.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT intolerance Day7; n= 0,0,1,0,2,2	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	400.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	NA International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	118.5 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.	590.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels GGT follow up; n= 18,20,3,3,3,2	84.6 International Unit per liter (IU/L) Standard Deviation 158.30	84.9 International Unit per liter (IU/L) Standard Deviation 164.37	140.0 International Unit per liter (IU/L) Standard Deviation 89.87	78.0 International Unit per liter (IU/L) Standard Deviation 29.87	224.0 International Unit per liter (IU/L) Standard Deviation 24.56	216.0 International Unit per liter (IU/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; intolerance Day4; n= 0,0,0,1,0,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	153.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; intolerance Day6; n= 0,0,0,1,1,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-20.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	27.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; intolerance Day7; n= 0,0,1,0,1,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-270.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-100.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	60.40 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; Day 2; n= 28,26,2,1,0,0	-1.246 micromoles per Liter (µmol/L) Standard Deviation 3.7551	0.088 micromoles per Liter (µmol/L) Standard Deviation 2.8035	0.800 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin Day3; n= 25,23,1,1,0,0	-1.512 micromoles per Liter (µmol/L) Standard Deviation 3.8420	-0.126 micromoles per Liter (µmol/L) Standard Deviation 3.2325	25.300 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; Day4; n= 19,18,0,0,0,0	0.700 micromoles per Liter (µmol/L) Standard Deviation 6.2765	0.172 micromoles per Liter (µmol/L) Standard Deviation 1.3323	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; Day5; n= 17,15,0,0,0,0	1.482 micromoles per Liter (µmol/L) Standard Deviation 10.6636	-1.007 micromoles per Liter (µmol/L) Standard Deviation 4.7148	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; Day6; n= 13,12,0,0,0,0	1.031 micromoles per Liter (µmol/L) Standard Deviation 9.5551	-0.583 micromoles per Liter (µmol/L) Standard Deviation 2.5933	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; Day7; n= 10,7,0,0,0,0	3.240 micromoles per Liter (µmol/L) Standard Deviation 16.6513	-1.214 micromoles per Liter (µmol/L) Standard Deviation 4.9229	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	7.100 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	7.100 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.700 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	12.167 micromoles per Liter (µmol/L) Standard Deviation 19.9144
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	5.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	4.800 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	4.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.050 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-7.100 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-8.050 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Direct bilirubin; follow up; n= 13,15,2,2,2,2	-1.969 micromoles per Liter (µmol/L) Standard Deviation 3.6992	-1.507 micromoles per Liter (µmol/L) Standard Deviation 4.2699	0.100 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	16.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-15.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day2; n= 32,35,2,2,0,0	-1.172 micromoles per Liter (µmol/L) Standard Deviation 4.4060	0.326 micromoles per Liter (µmol/L) Standard Deviation 4.0836	-1.350 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day3; n= 29,30,1,1,0,0	-1.038 micromoles per Liter (µmol/L) Standard Deviation 3.6544	-0.660 micromoles per Liter (µmol/L) Standard Deviation 7.4569	25.700 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day4; n= 25,25,0,0,0,0	0.496 micromoles per Liter (µmol/L) Standard Deviation 8.6799	-0.840 micromoles per Liter (µmol/L) Standard Deviation 7.1559	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day5; n=22,22,0,0,0,0	1.168 micromoles per Liter (µmol/L) Standard Deviation 12.9402	-1.055 micromoles per Liter (µmol/L) Standard Deviation 6.5842	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day6; n= 18,19,0,0,0,0	0.772 micromoles per Liter (µmol/L) Standard Deviation 11.3841	-1.558 micromoles per Liter (µmol/L) Standard Deviation 7.2077	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; Day7; n= 14,12,0,0,0,0	2.964 micromoles per Liter (µmol/L) Standard Deviation 17.7740	-3.133 micromoles per Liter (µmol/L) Standard Deviation 10.6133	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0	-1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	6.700 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.667 micromoles per Liter (µmol/L) Standard Deviation 2.5166	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	7.100 micromoles per Liter (µmol/L) Standard Deviation 4.5310	1.000 micromoles per Liter (µmol/L) Standard Deviation 2.6458	-0.075 micromoles per Liter (µmol/L) Standard Deviation 1.0751	4.675 micromoles per Liter (µmol/L) Standard Deviation 6.6249
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	5.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.333 micromoles per Liter (µmol/L) Standard Deviation 3.2146	0.167 micromoles per Liter (µmol/L) Standard Deviation 0.7638	10.475 micromoles per Liter (µmol/L) Standard Deviation 19.6274
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	5.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	3.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.833 micromoles per Liter (µmol/L) Standard Deviation 2.7538	3.333 micromoles per Liter (µmol/L) Standard Deviation 4.9329
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	7.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.633 micromoles per Liter (µmol/L) Standard Deviation 2.0984	-1.100 micromoles per Liter (µmol/L) Standard Deviation 4.2579
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	7.500 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	0.000 micromoles per Liter (µmol/L) Standard Deviation 2.0000	-8.050 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-0.800 micromoles per Liter (µmol/L) Standard Deviation 2.3065	-9.250 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Total bilirubin; follow up; n= 19,20,3,2,4,2	-1.263 micromoles per Liter (µmol/L) Standard Deviation 4.8442	-1.805 micromoles per Liter (µmol/L) Standard Deviation 8.3199	-0.467 micromoles per Liter (µmol/L) Standard Deviation 8.2978	-2.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	10.850 micromoles per Liter (µmol/L) Standard Deviation 25.5152	-17.000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day2; n= 33,37,2,2,0,0	-2.1818 micromoles per Liter (µmol/L) Standard Deviation 9.34898	-1.4281 micromoles per Liter (µmol/L) Standard Deviation 28.09838	-13.5000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-5.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day3; n= 29,31,1,1,0,0	-4.2724 micromoles per Liter (µmol/L) Standard Deviation 16.74713	-5.0323 micromoles per Liter (µmol/L) Standard Deviation 22.15774	-3.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-3.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day4; n= 25,26,0,0,0,0	-6.2400 micromoles per Liter (µmol/L) Standard Deviation 14.29534	-3.6923 micromoles per Liter (µmol/L) Standard Deviation 32.58683	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day5; n= 22,22,0,0,0,0	-7.0909 micromoles per Liter (µmol/L) Standard Deviation 16.52389	1.5909 micromoles per Liter (µmol/L) Standard Deviation 52.62053	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day6; n= 18,19,0,0,0,0	-7.5000 micromoles per Liter (µmol/L) Standard Deviation 21.34658	19.7895 micromoles per Liter (µmol/L) Standard Deviation 83.59198	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; Day7; n= 14,15,0,0,0,0	-7.5714 micromoles per Liter (µmol/L) Standard Deviation 26.46831	6.4000 micromoles per Liter (µmol/L) Standard Deviation 78.29322	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day1; n= 1,0,2,3,0,0	-11.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	1.5000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.6667 micromoles per Liter (µmol/L) Standard Deviation 3.51188	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day2; n= 0,0,3,3,4,4	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.6667 micromoles per Liter (µmol/L) Standard Deviation 10.06645	-5.6667 micromoles per Liter (µmol/L) Standard Deviation 5.13160	5.7500 micromoles per Liter (µmol/L) Standard Deviation 20.79062	-1.5000 micromoles per Liter (µmol/L) Standard Deviation 11.90238
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day3; n= 0,0,2,3,3,4	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-5.5000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-4.6667 micromoles per Liter (µmol/L) Standard Deviation 5.50757	3.3333 micromoles per Liter (µmol/L) Standard Deviation 36.29509	-21.5000 micromoles per Liter (µmol/L) Standard Deviation 22.60531
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day4; n= 0,0,2,2,3,3	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-1.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-6.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-13.0000 micromoles per Liter (µmol/L) Standard Deviation 30.34798	-14.0000 micromoles per Liter (µmol/L) Standard Deviation 22.60531
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day5; n= 0,0,2,1,3,3	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-23.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-10.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-11.3333 micromoles per Liter (µmol/L) Standard Deviation 27.15388	-16.6667 micromoles per Liter (µmol/L) Standard Deviation 20.59935
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day6; n= 0,0,2,1,3,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-28.5000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-10.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-12.3333 micromoles per Liter (µmol/L) Standard Deviation 34.93327	-32.5000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; intolerance Day7; n= 0,0,1,0,3,2	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-50.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-4.3333 micromoles per Liter (µmol/L) Standard Deviation 48.33563	-34.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Creatinine; follow up; n= 25,28,3,3,4,2	-5.8400 micromoles per Liter (µmol/L) Standard Deviation 20.46477	11.6786 micromoles per Liter (µmol/L) Standard Deviation 103.9060	-34.0000 micromoles per Liter (µmol/L) Standard Deviation 13.52775	-4.0000 micromoles per Liter (µmol/L) Standard Deviation 11.35782	-12.0000 micromoles per Liter (µmol/L) Standard Deviation 24.17988	-39.0000 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; Day3; n= 0,1,0,0,0,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-70.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; Day5; n= 0,2,0,0,0,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-20.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; Day6; n= 0,1,0,0,0,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	282.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; Day7; 11,11,0,0,0,0	-20.18 micromoles per Liter (µmol/L) Standard Deviation 108.547	-15.36 micromoles per Liter (µmol/L) Standard Deviation 152.550	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; intolerance Day2; n= 0,0,0,0,0,1	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-3640.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid; intolerance Day3; n= 0,0,0,1,0,0	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	-20.00 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	NA micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels Uric acid follow up; n= 15,14,2,3,3,2	60.47 micromoles per Liter (µmol/L) Standard Deviation 96.092	58.36 micromoles per Liter (µmol/L) Standard Deviation 144.871	-25.50 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.	115.67 micromoles per Liter (µmol/L) Standard Deviation 106.228	72.33 micromoles per Liter (µmol/L) Standard Deviation 118.095	1076.90 micromoles per Liter (µmol/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; intolerance Day 7; n= 0,0,1,0,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.0700 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.2000 millimol per liter (mmol/L) Standard Deviation 0.36661	0.0200 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day4 ; n= 25,26,0,0,0,0	-2.3 millimol per liter (mmol/L) Standard Deviation 3.93	-1.8 millimol per liter (mmol/L) Standard Deviation 5.86	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day5; n= 22,23,0,0,0,0	-3.4 millimol per liter (mmol/L) Standard Deviation 5.64	-2.6 millimol per liter (mmol/L) Standard Deviation 6.93	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day 6; n= 18,19,0,0,0,0	-4.1 millimol per liter (mmol/L) Standard Deviation 7.28	-4.8 millimol per liter (mmol/L) Standard Deviation 7.52	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 5; n= 20,22,0,0,0,0	-0.16 millimol per liter (mmol/L) Standard Deviation 3.797	1.64 millimol per liter (mmol/L) Standard Deviation 7.631	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.65 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day5; n= 22,21,0,0,0,0	0.4636 millimol per liter (mmol/L) Standard Deviation 2.76811	0.1810 millimol per liter (mmol/L) Standard Deviation 2.05928	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day5; n= 0,0,2,1,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.5500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.2000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.2333 millimol per liter (mmol/L) Standard Deviation 3.27159	0.9333 millimol per liter (mmol/L) Standard Deviation 0.87369
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; Day3; n= 29,31,1,1,0,0	-0.12 millimol per liter (mmol/L) Standard Deviation 0.582	0.01 millimol per liter (mmol/L) Standard Deviation 0.489	-0.40 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.10 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; DAY4; n= 24,25,0,0,0,0	0.08 millimol per liter (mmol/L) Standard Deviation 0.705	0.06 millimol per liter (mmol/L) Standard Deviation 0.515	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; Day6; n= 18,19,0,0,0,0	0.33 millimol per liter (mmol/L) Standard Deviation 0.428	0.09 millimol per liter (mmol/L) Standard Deviation 0.732	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day2; n= 0,0,3,3,4,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.00 millimol per liter (mmol/L) Standard Deviation 0.557	0.17 millimol per liter (mmol/L) Standard Deviation 0.289	0.40 millimol per liter (mmol/L) Standard Deviation 0.258	-0.18 millimol per liter (mmol/L) Standard Deviation 0.263
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day3; n= 0,0,2,3,3,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.30 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.30 millimol per liter (mmol/L) Standard Deviation 0.656	0.30 millimol per liter (mmol/L) Standard Deviation 0.721	-0.53 millimol per liter (mmol/L) Standard Deviation 1.011
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day4; n= 0,0,2,2,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.15 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.45 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.63 millimol per liter (mmol/L) Standard Deviation 0.945	-0.10 millimol per liter (mmol/L) Standard Deviation 1.136
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day5; n= 0,0,2,1,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.35 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.20 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.67 millimol per liter (mmol/L) Standard Deviation 0.987	-0.03 millimol per liter (mmol/L) Standard Deviation 1.115
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day2; n= 33,37,2,2,0,0	0.3 millimol per liter (mmol/L) Standard Deviation 2.02	0.8 millimol per liter (mmol/L) Standard Deviation 3.34	1.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day3; n= 29,31,1,1,0,0	0.4 millimol per liter (mmol/L) Standard Deviation 2.47	1.2 millimol per liter (mmol/L) Standard Deviation 4.20	0.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-5.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day4; n= 25,26,0,0,0,0	-0.8 millimol per liter (mmol/L) Standard Deviation 4.03	1.5 millimol per liter (mmol/L) Standard Deviation 4.92	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day5; n= 22,23,0,0,0,0	-1.4 millimol per liter (mmol/L) Standard Deviation 4.62	0.8 millimol per liter (mmol/L) Standard Deviation 5.24	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day6; n= 18,19,0,0,0,0	-2.8 millimol per liter (mmol/L) Standard Deviation 6.18	-0.2 millimol per liter (mmol/L) Standard Deviation 6.39	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; Day7; n= 14,15,0,0,0,0	-2.7 millimol per liter (mmol/L) Standard Deviation 6.40	0.1 millimol per liter (mmol/L) Standard Deviation 4.24	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day1; n= 1,0,2,3,0,0	-3.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-1.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-2.3 millimol per liter (mmol/L) Standard Deviation 6.66	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day2; n= 0,0,3,3,4,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.0 millimol per liter (mmol/L) Standard Deviation 2.65	-3.3 millimol per liter (mmol/L) Standard Deviation 6.66	-0.5 millimol per liter (mmol/L) Standard Deviation 2.38	1.0 millimol per liter (mmol/L) Standard Deviation 2.16
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day3; n= 0,0,2,3,3,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-3.0 millimol per liter (mmol/L) Standard Deviation 8.89	3.7 millimol per liter (mmol/L) Standard Deviation 3.21	-0.5 millimol per liter (mmol/L) Standard Deviation 4.65
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day4; n= 0,0,2,2,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-8.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.7 millimol per liter (mmol/L) Standard Deviation 2.31	0.0 millimol per liter (mmol/L) Standard Deviation 6.93
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day5; n= 0,0,2,1,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	5.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	6.3 millimol per liter (mmol/L) Standard Deviation 2.31	0.0 millimol per liter (mmol/L) Standard Deviation 6.08
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day6; n= 0,0,2,1,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-2.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	7.3 millimol per liter (mmol/L) Standard Deviation 2.52	-1.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; intolerance Day7; n= 0,0,1,0,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	6.3 millimol per liter (mmol/L) Standard Deviation 6.66	-2.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day3; n= 1,2,0,0,0,0	6.4000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.4000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day4; n= 0,1,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.5000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; intolerance Day3; n= 0,0,0,1,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.2000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; intolerance Day4; n= 0,0,0,1,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.3000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; intolerance Day6; n= 0,0,1,1,1,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	7.4000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.2000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	14.2000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; intolerance Day7; n= 0,0,1,0,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-1.0000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	16.4000 millimol per liter (mmol/L) Standard Deviation 18.72004	1.1500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; follow up; n= 18,22,3,3,4,1	2.1722 millimol per liter (mmol/L) Standard Deviation 5.48397	1.7000 millimol per liter (mmol/L) Standard Deviation 6.75891	-0.3333 millimol per liter (mmol/L) Standard Deviation 3.30807	4.5667 millimol per liter (mmol/L) Standard Deviation 1.59478	11.6500 millimol per liter (mmol/L) Standard Deviation 21.03656	2.8000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day4; n= 25,24,0,0,0,0	0.7680 millimol per liter (mmol/L) Standard Deviation 2.69764	-0.1458 millimol per liter (mmol/L) Standard Deviation 1.96778	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day6; n= 18,18,0,0,0,0	0.8111 millimol per liter (mmol/L) Standard Deviation 3.37445	0.0889 millimol per liter (mmol/L) Standard Deviation 1.74150	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day7; n= 14,13,0,0,0,0	1.8857 millimol per liter (mmol/L) Standard Deviation 4.17702	0.8692 millimol per liter (mmol/L) Standard Deviation 2.33323	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day1; n= 1,0,2,3,0,0	-0.9000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-1.6000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.2000 millimol per liter (mmol/L) Standard Deviation 1.30000	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day2; n= 0,0,3,3,4,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.5000 millimol per liter (mmol/L) Standard Deviation 2.85132	-0.3000 millimol per liter (mmol/L) Standard Deviation 0.62450	-0.4500 millimol per liter (mmol/L) Standard Deviation 2.49600	0.8000 millimol per liter (mmol/L) Standard Deviation 1.50000
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day3; n= 0,0,2,3,3,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.5000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.1000 millimol per liter (mmol/L) Standard Deviation 1.21244	0.7333 millimol per liter (mmol/L) Standard Deviation 1.90875	0.6000 millimol per liter (mmol/L) Standard Deviation 1.78699
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day4; n= 0,0,2,2,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.8500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.3000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.1000 millimol per liter (mmol/L) Standard Deviation 2.88444	1.1667 millimol per liter (mmol/L) Standard Deviation 0.32146
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day6; n= 0,0,2,1,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.1000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.7000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.8000 millimol per liter (mmol/L) Standard Deviation 1.70880	0.6500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; intolerance Day7; n= 0,0,1,0,2,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.8000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.5000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.1500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; follow up; n= 18,17,3,3,4,2	-0.8889 millimol per liter (mmol/L) Standard Deviation 2.55225	-1.7176 millimol per liter (mmol/L) Standard Deviation 1.99663	-1.9667 millimol per liter (mmol/L) Standard Deviation 3.21921	-0.3333 millimol per liter (mmol/L) Standard Deviation 0.72342	-1.1750 millimol per liter (mmol/L) Standard Deviation 2.57083	2.6000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; Day2; n= 33,37,2,2,0,0	-0.08 millimol per liter (mmol/L) Standard Deviation 0.474	0.02 millimol per liter (mmol/L) Standard Deviation 0.447	-0.20 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.20 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium Day5; n= 22,23,0,0,0,0	0.10 millimol per liter (mmol/L) Standard Deviation 0.559	0.07 millimol per liter (mmol/L) Standard Deviation 0.644	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; Day7; n= 14,15,0,0,0,0	0.49 millimol per liter (mmol/L) Standard Deviation 0.350	0.05 millimol per liter (mmol/L) Standard Deviation 0.741	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day1; n= 1,0,2,3,0,0	0.40 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.17 millimol per liter (mmol/L) Standard Deviation 0.379	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 2; n= 1,2,0,0,0,0	-0.0500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.0000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 3; n= 1,2,0,0,0,0	0.0200 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.1300 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 4; n= 0,1,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.0800 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 5; n= 0,2,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.1500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 6; n= 0,1,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.0100 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; Day 7; n= 12,12,0,0,0,0	0.2208 millimol per liter (mmol/L) Standard Deviation 0.29222	0.0733 millimol per liter (mmol/L) Standard Deviation 0.12390	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; intolerance Day 2; n= 0,0,0,0,0,1	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.0400 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; intolerance Day 3; n= 0,0,0,1,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.3400 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; intolerance Day 4; n= 0,0,0,1,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.2100 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; intolerance Day 6; n= 0,0,1,1,1,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.3400 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.3600 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.4300 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Calcium; follow up; n= 19,18,3,3,4,2	0.2821 millimol per liter (mmol/L) Standard Deviation 0.19277	0.2483 millimol per liter (mmol/L) Standard Deviation 0.24957	0.2667 millimol per liter (mmol/L) Standard Deviation 0.02517	0.4767 millimol per liter (mmol/L) Standard Deviation 0.22008	0.2850 millimol per liter (mmol/L) Standard Deviation 0.39467	0.2050 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day 2; n= 33,37,2,2,0,0	-1.2 millimol per liter (mmol/L) Standard Deviation 2.66	-0.6 millimol per liter (mmol/L) Standard Deviation 3.38	-2.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day3; n= 28,31,1,1,0,0	-1.5 millimol per liter (mmol/L) Standard Deviation 3.38	-1.3 millimol per liter (mmol/L) Standard Deviation 4.26	-5.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-7.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride; Day7; n= 14,15,0,0,0,0	-4.3 millimol per liter (mmol/L) Standard Deviation 7.49	-3.1 millimol per liter (mmol/L) Standard Deviation 7.14	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 1; n= 1,0,2,3,0,0	-1.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-6.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-3.7 millimol per liter (mmol/L) Standard Deviation 9.07	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 2; n= 0,0,3,3,4,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-5.3 millimol per liter (mmol/L) Standard Deviation 3.21	-4.3 millimol per liter (mmol/L) Standard Deviation 8.50	0.5 millimol per liter (mmol/L) Standard Deviation 1.00	-0.5 millimol per liter (mmol/L) Standard Deviation 3.42
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 3; n= 0,0,2,3,2,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-6.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-6.0 millimol per liter (mmol/L) Standard Deviation 9.54	0.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-2.3 millimol per liter (mmol/L) Standard Deviation 4.99
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 4; n= 0,0,2,2,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-5.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-11.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.3 millimol per liter (mmol/L) Standard Deviation 0.58	-4.0 millimol per liter (mmol/L) Standard Deviation 7.00
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 5; n= 0,0,2,1,3,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-1.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-2.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.3 millimol per liter (mmol/L) Standard Deviation 1.53	-4.7 millimol per liter (mmol/L) Standard Deviation 4.51
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 6; n= 0,0,2,1,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-4.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	5.7 millimol per liter (mmol/L) Standard Deviation 2.08	-4.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride intolerance Day 7; n= 0,0,1,0,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.0 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.3 millimol per liter (mmol/L) Standard Deviation 4.04	-6.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Chloride follow up; n= 22,23,3,3,3,2	-6.1 millimol per liter (mmol/L) Standard Deviation 6.71	-4.6 millimol per liter (mmol/L) Standard Deviation 6.27	-7.3 millimol per liter (mmol/L) Standard Deviation 5.51	-11.0 millimol per liter (mmol/L) Standard Deviation 5.57	-7.0 millimol per liter (mmol/L) Standard Deviation 6.08	-8.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 2; n= 32,36,2,2,0,0	3.31 millimol per liter (mmol/L) Standard Deviation 10.711	0.21 millimol per liter (mmol/L) Standard Deviation 3.770	2.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 3; n= 27,31,1,1,0,0	1.64 millimol per liter (mmol/L) Standard Deviation 2.274	0.93 millimol per liter (mmol/L) Standard Deviation 6.406	6.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 4; n= 24,25,0,0,0,0	0.43 millimol per liter (mmol/L) Standard Deviation 3.958	1.58 millimol per liter (mmol/L) Standard Deviation 8.054	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 6; n= 16,16,0,0,0,0	0.64 millimol per liter (mmol/L) Standard Deviation 5.728	3.63 millimol per liter (mmol/L) Standard Deviation 5.308	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; Day 7; n= 12,13,0,0,0,0	0.98 millimol per liter (mmol/L) Standard Deviation 5.774	3.05 millimol per liter (mmol/L) Standard Deviation 4.945	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0	2.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.33 millimol per liter (mmol/L) Standard Deviation 2.082	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.67 millimol per liter (mmol/L) Standard Deviation 1.528	0.33 millimol per liter (mmol/L) Standard Deviation 0.577	-2.00 millimol per liter (mmol/L) Standard Deviation 3.000	0.93 millimol per liter (mmol/L) Standard Deviation 2.844
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	6.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	1.67 millimol per liter (mmol/L) Standard Deviation 2.309	1.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.80 millimol per liter (mmol/L) Standard Deviation 5.071
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	5.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.40 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	6.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.75 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	3.50 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	5.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.00 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	4.15 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Carbon dioxide; follow up; n= 15,20,3,3,3,2	-1.26 millimol per liter (mmol/L) Standard Deviation 6.069	-0.40 millimol per liter (mmol/L) Standard Deviation 5.088	1.67 millimol per liter (mmol/L) Standard Deviation 2.082	1.67 millimol per liter (mmol/L) Standard Deviation 3.215	1.67 millimol per liter (mmol/L) Standard Deviation 1.528	1.45 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day2; n= 31,35,2,2,0,0	0.2871 millimol per liter (mmol/L) Standard Deviation 2.68325	-0.2338 millimol per liter (mmol/L) Standard Deviation 1.89890	-0.8000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.3000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Glucose; Day3; n= 29,29,1,1,0,0	0.2414 millimol per liter (mmol/L) Standard Deviation 3.12667	0.0655 millimol per liter (mmol/L) Standard Deviation 2.10514	-2.9000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-1.6000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day6; n= 0,0,2,1,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.05 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.40 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.83 millimol per liter (mmol/L) Standard Deviation 1.115	-0.55 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; intolerance Day7; n= 0,0,1,0,3,2	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	-0.10 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	0.87 millimol per liter (mmol/L) Standard Deviation 1.328	-0.60 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Potassium; follow up; n= 25,28,3,3,4,2	0.37 millimol per liter (mmol/L) Standard Deviation 0.471	0.11 millimol per liter (mmol/L) Standard Deviation 0.676	-0.07 millimol per liter (mmol/L) Standard Deviation 0.379	0.47 millimol per liter (mmol/L) Standard Deviation 0.651	0.38 millimol per liter (mmol/L) Standard Deviation 0.443	-0.10 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values Sodium; follow up; n= 25,28,3,3,4,2	-3.8 millimol per liter (mmol/L) Standard Deviation 4.92	-2.5 millimol per liter (mmol/L) Standard Deviation 5.12	-3.0 millimol per liter (mmol/L) Standard Deviation 3.46	-7.0 millimol per liter (mmol/L) Standard Deviation 6.08	-0.5 millimol per liter (mmol/L) Standard Deviation 5.45	-6.5 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day2; n= 1,3,0,0,0,0	1.0000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	2.3000 millimol per liter (mmol/L) Standard Deviation 4.60326	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day5; n= 0,2,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	25.8500 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day6; n= 0,1,0,0,0,0	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	29.2000 millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values BUN; Day7; n= 13,14,0,0,0,0	3.1231 millimol per liter (mmol/L) Standard Deviation 5.15948	5.0143 millimol per liter (mmol/L) Standard Deviation 9.35002	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.	NA millimol per liter (mmol/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.7300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; Day3; n= 2,1,0,0,0,0	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.020 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; Day5; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.050 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; Day6; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; intolerance Day2; n= 0,0,0,0,0,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA c	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.030 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; Day7; n= 13,15,0,0,0,0	0.2100 Giga unit per liter (gI/L) Standard Deviation 0.59020	0.1647 Giga unit per liter (gI/L) Standard Deviation 0.49461	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; intolerance Day6; n= 0,0,1,1,1,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.9000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.3600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.5000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; intolerance Day7; n= 0,0,1,0,3,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.6900 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0600 Giga unit per liter (gI/L) Standard Deviation 0.29866	1.3000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; Day7; n= 13,15,0,0,0,0	0.6708 Giga unit per liter (gI/L) Standard Deviation 7.11859	1.1807 Giga unit per liter (gI/L) Standard Deviation 3.99306	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; intolerance Day2; n= 0,0,0,0,0,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.3100 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; follow up; n= 24,28,3,3,4,2	-2.0579 Giga unit per liter (gI/L) Standard Deviation 6.73610	-2.0968 Giga unit per liter (gI/L) Standard Deviation 3.26061	-0.7133 Giga unit per liter (gI/L) Standard Deviation 5.15272	-0.5233 Giga unit per liter (gI/L) Standard Deviation 1.90500	0.8250 Giga unit per liter (gI/L) Standard Deviation 12.60760	-6.7400 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day2; n= 32,37,2,2,0,0	10.5 Giga unit per liter (gI/L) Standard Deviation 40.92	4.2 Giga unit per liter (gI/L) Standard Deviation 22.00	8.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	14.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day3; n= 29,30,1,1,0,0	34.8 Giga unit per liter (gI/L) Standard Deviation 65.68	22.1 Giga unit per liter (gI/L) Standard Deviation 35.90	-4.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	10.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day6; n= 17,19,0,0,0,0	128.7 Giga unit per liter (gI/L) Standard Deviation 168.94	113.6 Giga unit per liter (gI/L) Standard Deviation 95.44	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance Day1; n= 1,0,2,3,0,0	-24.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	33.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	21.0 Giga unit per liter (gI/L) Standard Deviation 39.89	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance Day3; n= 0,0,2,3,3,4	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	101.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	31.7 Giga unit per liter (gI/L) Standard Deviation 64.79	0.7 Giga unit per liter (gI/L) Standard Deviation 46.70	29.0 Giga unit per liter (gI/L) Standard Deviation 56.94
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance Day4; n= 0,0,2,2,3,3	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	183.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	42.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	11.0 Giga unit per liter (gI/L) Standard Deviation 67.58	86.3 Giga unit per liter (gI/L) Standard Deviation 57.36
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance Day5; n= 0,0,2,1,3,3	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	213.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-10.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	14.7 Giga unit per liter (gI/L) Standard Deviation 75.24	158.0 Giga unit per liter (gI/L) Standard Deviation 99.05
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day4; n= 0,0,2,2,3,3	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	1.150 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-2.125 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.300 Giga unit per liter (gI/L) Standard Deviation 4.8446	-2.933 Giga unit per liter (gI/L) Standard Deviation 6.4733
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day5; n= 0,0,2,1,3,3	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	1.850 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.490 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.450 Giga unit per liter (gI/L) Standard Deviation 8.5339	-1.800 Giga unit per liter (gI/L) Standard Deviation 5.4009
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day6; n= 0,0,2,1,3,2	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.750 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.367 Giga unit per liter (gI/L) Standard Deviation 8.8047	-5.600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; Day6; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.2000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; Day7; n= 13,14,0,0,0,0	0.1615 Giga unit per liter (gI/L) Standard Deviation 0.12877	0.1079 Giga unit per liter (gI/L) Standard Deviation 0.22337	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; intolerance Day2; n= 0,0,0,0,0,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.0200 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; intolerance Day3; n= 0,0,0,2,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; intolerance Day4; n= 0,0,0,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; intolerance Day6; n= 0,0,1,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.3300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; intolerance Day7; n= 0,0,1,0,3,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.7900 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.0000 Giga unit per liter (gI/L) Standard Deviation 0.19079	0.1000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; follow up; n= 24,28,3,3,4,1	1.4454 Giga unit per liter (gI/L) Standard Deviation 6.27749	0.1886 Giga unit per liter (gI/L) Standard Deviation 0.27639	0.3367 Giga unit per liter (gI/L) Standard Deviation 0.14844	0.2267 Giga unit per liter (gI/L) Standard Deviation 0.14189	0.0400 Giga unit per liter (gI/L) Standard Deviation 0.81404	-0.0200 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; Day2; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.2000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; Day3; n= 2,1,0,0,0,0	0.6500 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.0300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; Day5; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.4400 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; Day6; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.2000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; Day7; n= 13,15,0,0,0,0	0.3946 Giga unit per liter (gI/L) Standard Deviation 0.56592	0.2320 Giga unit per liter (gI/L) Standard Deviation 0.66890	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.3550 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.2000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.1000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.4800 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.4000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.4600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.1900 Giga unit per liter (gI/L) Standard Deviation 0.19925	1.5000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Lymphocytes; follow up; n= 24,28,3,3,4,2	0.6483 Giga unit per liter (gI/L) Standard Deviation 0.51967	0.6614 Giga unit per liter (gI/L) Standard Deviation 0.75393	0.3133 Giga unit per liter (gI/L) Standard Deviation 0.53529	0.7067 Giga unit per liter (gI/L) Standard Deviation 0.50013	0.7100 Giga unit per liter (gI/L) Standard Deviation 0.58395	-0.1200 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; Day2; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.4000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; Day3; n= 2,1,0,0,0,0	0.5000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.0600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; Day5; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.0300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; Day6; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.2000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; intolerance Day2; n= 0,0,0,0,0,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; intolerance Day3; n= 0,0,0,2,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0900 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; intolerance Day4; n= 0,0,0,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.1000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Monocytes; follow up; n= 24,28,3,3,3,1	0.1475 Giga unit per liter (gI/L) Standard Deviation 0.55989	0.0611 Giga unit per liter (gI/L) Standard Deviation 0.39000	-0.1067 Giga unit per liter (gI/L) Standard Deviation 0.46058	-0.0633 Giga unit per liter (gI/L) Standard Deviation 0.20502	-0.4900 Giga unit per liter (gI/L) Standard Deviation 0.56427	0.3600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; Day2; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.5000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; Day3; n= 2,1,0,0,0,0	-5.3000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.7200 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; Day5; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.3750 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; Day6; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	9.6000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; intolerance Day3; n= 0,0,0,2,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-2.1000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; intolerance Day4; n= 0,0,0,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-2.9000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; follow up; n= 24,28,3,3,4,2	-1.223 Giga unit per liter (gI/L) Standard Deviation 7.5546	-0.813 Giga unit per liter (gI/L) Standard Deviation 3.7488	-0.177 Giga unit per liter (gI/L) Standard Deviation 5.0906	0.230 Giga unit per liter (gI/L) Standard Deviation 2.4557	2.188 Giga unit per liter (gI/L) Standard Deviation 13.4717	-6.150 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; intolerance Day6; n= 0,0,1,1,1,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	1.1000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.8100 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	7.5000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Neutrophils; intolerance Day7; n= 0,0,1,0,3,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	1.4600 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.7200 Giga unit per liter (gI/L) Standard Deviation 8.10489	-6.6000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day4; n= 25,26,0,0,0,0	56.0 Giga unit per liter (gI/L) Standard Deviation 98.65	48.7 Giga unit per liter (gI/L) Standard Deviation 55.92	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day5; n= 22,23,0,0,0,0	102.7 Giga unit per liter (gI/L) Standard Deviation 141.00	82.7 Giga unit per liter (gI/L) Standard Deviation 75.37	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; Day7; n= 14,15,0,0,0,0	159.8 Giga unit per liter (gI/L) Standard Deviation 229.46	133.3 Giga unit per liter (gI/L) Standard Deviation 99.92	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance Day2; n= 0,0,3,3,4,4	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	73.7 Giga unit per liter (gI/L) Standard Deviation 21.20	13.7 Giga unit per liter (gI/L) Standard Deviation 73.15	-8.8 Giga unit per liter (gI/L) Standard Deviation 24.25	16.3 Giga unit per liter (gI/L) Standard Deviation 30.10
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance day6; n= 0,0,2,1,3,2	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	225.5 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	42.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	26.0 Giga unit per liter (gI/L) Standard Deviation 84.55	271.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; intolerance day7; n= 0,0,1,0,3,2	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	287.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	49.7 Giga unit per liter (gI/L) Standard Deviation 106.59	429.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Platelet; follow up; n= 24,28,3,3,4,2	258.9 Giga unit per liter (gI/L) Standard Deviation 268.60	272.0 Giga unit per liter (gI/L) Standard Deviation 226.86	438.0 Giga unit per liter (gI/L) Standard Deviation 194.76	272.0 Giga unit per liter (gI/L) Standard Deviation 27.87	66.8 Giga unit per liter (gI/L) Standard Deviation 272.20	891.0 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day2; n= 32,37,2,2,0,0	-1.187 Giga unit per liter (gI/L) Standard Deviation 3.5946	-0.199 Giga unit per liter (gI/L) Standard Deviation 2.5427	-2.490 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-2.320 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day3; n= 29,30,1,1,0,0	-1.033 Giga unit per liter (gI/L) Standard Deviation 5.8272	0.398 Giga unit per liter (gI/L) Standard Deviation 3.0461	0.300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-4.400 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day4; n= 25,26,0,0,0,0	-1.398 Giga unit per liter (gI/L) Standard Deviation 6.0244	0.489 Giga unit per liter (gI/L) Standard Deviation 3.7565	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day5; n= 22,23,0,0,0,0	-0.015 Giga unit per liter (gI/L) Standard Deviation 6.5214	1.320 Giga unit per liter (gI/L) Standard Deviation 3.6270	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day6; n= 17,19,0,0,0,0	0.881 Giga unit per liter (gI/L) Standard Deviation 8.4975	2.314 Giga unit per liter (gI/L) Standard Deviation 4.6829	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; Day7; n= 14,15,0,0,0,0	0.690 Giga unit per liter (gI/L) Standard Deviation 8.9417	1.913 Giga unit per liter (gI/L) Standard Deviation 3.8002	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day1; n= 1,0,2,3,0,0	-2.020 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.220 Giga unit per liter (gI/L) Standard Deviation 2.6018	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day2; n= 0,0,3,3,4,4	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.197 Giga unit per liter (gI/L) Standard Deviation 2.1019	-1.713 Giga unit per liter (gI/L) Standard Deviation 3.4082	-1.050 Giga unit per liter (gI/L) Standard Deviation 3.3491	0.450 Giga unit per liter (gI/L) Standard Deviation 4.6177
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day3; n= 0,0,2,3,3,4	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.910 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-1.447 Giga unit per liter (gI/L) Standard Deviation 2.4791	-2.333 Giga unit per liter (gI/L) Standard Deviation 5.1733	-2.925 Giga unit per liter (gI/L) Standard Deviation 4.9304
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels WBC; intolerance Day7; n= 0,0,1,0,3,2	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	4.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.540 Giga unit per liter (gI/L) Standard Deviation 8.7199	-3.650 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; Day2; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; Day7; n= 13,14,0,0,0,0	0.022 Giga unit per liter (gI/L) Standard Deviation 0.0402	0.013 Giga unit per liter (gI/L) Standard Deviation 0.0281	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; intolerance Day3; n= 0,0,0,2,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; intolerance Day4; n= 0,0,0,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; intolerance Day6; n= 0,0,1,1,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.020 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; intolerance Day7; n= 0,0,1,0,3,1	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.130 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.037 Giga unit per liter (gI/L) Standard Deviation 0.0603	0.300 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Basophils; follow up; n= 24,28,3,3,3,1	0.040 Giga unit per liter (gI/L) Standard Deviation 0.0546	0.034 Giga unit per liter (gI/L) Standard Deviation 0.0619	0.047 Giga unit per liter (gI/L) Standard Deviation 0.0503	0.057 Giga unit per liter (gI/L) Standard Deviation 0.0379	0.073 Giga unit per liter (gI/L) Standard Deviation 0.1401	0.150 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; Day2; n= 0,1,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; Day3; n= 2,1,0,0,0,0	0.3000 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	-0.0400 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels Eosinophils; Day5; n= 0,2,0,0,0,0	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	0.0900 Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.	NA Giga unit per liter (gI/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day2; n= 32,37,2,2,0,0	-2.7 g/L Standard Deviation 8.13	-1.8 g/L Standard Deviation 6.62	-10.5 g/L Standard Deviation NA NA indicates that data were not available.	-4.5 g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day3; n= 29,30,1,1,0,0	-4.6 g/L Standard Deviation 8.91	-2.1 g/L Standard Deviation 8.67	-6.0 g/L Standard Deviation NA NA indicates that data were not available.	-7.0 g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day4; n= 25,26,0,0,0,0	-4.8 g/L Standard Deviation 7.71	-4.7 g/L Standard Deviation 7.59	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day5; n= 22,23,0,0,0,0	-3.2 g/L Standard Deviation 10.40	-3.6 g/L Standard Deviation 10.28	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day6; n= 17,19,0,0,0,0	-5.6 g/L Standard Deviation 14.04	-4.7 g/L Standard Deviation 10.19	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Day7; n= 14,15,0,0,0,0	-5.9 g/L Standard Deviation 14.22	-5.9 g/L Standard Deviation 11.06	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0	-16.0 g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	2.0 g/L Standard Deviation NA NA indicates that data were not available.	-4.0 g/L Standard Deviation 1.73	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4	NA g/L Standard Deviation NA NA indicates that data were not available.	NA g/L Standard Deviation NA NA indicates that data were not available.	-4.7 g/L Standard Deviation 3.06	-8.7 g/L Standard Deviation 7.57	0.5 g/L Standard Deviation 4.20	-4.5 g/L Standard Deviation 2.52
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-11.5 g/L Standard Deviation NA NA indicates that data were not available	-11.0 g/L Standard Deviation 4.58	-2.7 g/L Standard Deviation 7.09	-3.8 g/L Standard Deviation 4.27
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-13.0 g/L Standard Deviation NA NA indicates that data were not available	-6.0 g/L Standard Deviation NA NA indicates that data were not available	-7.0 g/L Standard Deviation 10.00	4.3 g/L Standard Deviation 1.53
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-14.0 g/L Standard Deviation NA NA indicates that data were not available	-7.0 g/L Standard Deviation NA NA indicates that data were not available	5.7 g/L Standard Deviation 10.02	-5.5 g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-13.0 g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	2.7 g/L Standard Deviation 9.24	-5.5 g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; follow up; n= 24,28,3,3,4,2	5.1 g/L Standard Deviation 19.13	4.3 g/L Standard Deviation 13.21	15.7 g/L Standard Deviation 9.87	19.0 g/L Standard Deviation 8.19	3.5 g/L Standard Deviation 8.81	2.5 g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day2; n= 31,37,2,2,0,0	-1.26 g/L Standard Deviation 7.066	-0.27 g/L Standard Deviation 5.966	-2.50 g/L Standard Deviation NA NA indicates that data were not available	3.00 g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day3; n= 28,30,1,1,0,0	-1.29 g/L Standard Deviation 7.403	-2.00 g/L Standard Deviation 7.339	-13.00 g/L Standard Deviation NA NA indicates that data were not available	6.00 g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day4; n= 25,26,0,0,0,0	-1.24 g/L Standard Deviation 8.232	-5.54 g/L Standard Deviation 8.994	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day5; n= 22,23,0,0,0,0	-16.50 g/L Standard Deviation 68.162	-6.39 g/L Standard Deviation 9.852	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day6; n= 17,19,0,0,0,0	-1.94 g/L Standard Deviation 10.413	-6.89 g/L Standard Deviation 11.110	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; Day7; n= 14,15,0,0,0,0	-4.43 g/L Standard Deviation 13.461	-4.40 g/L Standard Deviation 9.934	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day1; n= 1,0,2,3,0,0	0.00 g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-18.50 g/L Standard Deviation NA NA indicates that data were not available	1.00 g/L Standard Deviation 8.544	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day5; n= 0,0,2,1,3,3	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-6.50 g/L Standard Deviation NA NA indicates that data were not available	-5.00 g/L Standard Deviation NA NA indicates that data were not available	-10.00 g/L Standard Deviation 12.288	-11.67 g/L Standard Deviation 23.352
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day6; n= 0,0,2,1,3,2	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-13.00 g/L Standard Deviation NA NA indicates that data were not available	-10.00 g/L Standard Deviation NA NA indicates that data were not available	-8.00 g/L Standard Deviation 18.248	-23.50 g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-5.0 g/L Standard Deviation NA NA indicates that data were not available	-10.0 g/L Standard Deviation NA NA indicates that data were not available	-0.7 g/L Standard Deviation 8.74	-1.7 g/L Standard Deviation 5.69
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day2; n= 0,0,3,3,4,4	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-19.00 g/L Standard Deviation 23.065	1.67 g/L Standard Deviation 12.702	-0.50 g/L Standard Deviation 4.655	-3.00 g/L Standard Deviation 6.831
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day3; n= 0,0,2,3,3,4	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-6.00 g/L Standard Deviation NA NA indicates that data were not available	5.33 g/L Standard Deviation 9.609	-2.67 g/L Standard Deviation 9.815	-3.75 g/L Standard Deviation 11.325
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day4; n= 0,0,2,2,3,3	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-12.50 g/L Standard Deviation NA NA indicates that data were not available	2.00 g/L Standard Deviation NA NA indicates that data were not available	-4.00 g/L Standard Deviation 6.557	-11.67 g/L Standard Deviation 18.230
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; intolerance Day7; n= 0,0,1,0,3,2	NA g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-25.00 g/L Standard Deviation NA NA indicates that data were not available	NA g/L Standard Deviation NA NA indicates that data were not available	-8.67 g/L Standard Deviation 15.535	-8.50 g/L Standard Deviation NA NA indicates that data were not available
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; follow up; n= 23,27,3,3,4,4	-2.57 g/L Standard Deviation 10.135	-6.33 g/L Standard Deviation 14.475	-22.00 g/L Standard Deviation 29.138	-5.33 g/L Standard Deviation 9.609	-11.75 g/L Standard Deviation 11.026	-25.00 g/L Standard Deviation NA NA indicates that data were not available

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Hematocrit Level Intolerance Day1; n= 1,0,2,3,0,0	-0.0400 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	0.0195 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0150 Fraction of 1 Standard Deviation 0.00500	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Intolerance Day3; n= 0,0,2,3,3,4	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0310 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0373 Fraction of 1 Standard Deviation 0.02053	-0.1917 Fraction of 1 Standard Deviation 0.30168	-0.0065 Fraction of 1 Standard Deviation 0.00790
Change From Baseline in Hematocrit Level Intolerance Day7; n= 0,0,1,0,3,2	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0200 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.1673 Fraction of 1 Standard Deviation 0.31439	-0.0120 Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Follow up; n= 24,28,3,3,4,2	0.0183 Fraction of 1 Standard Deviation 0.05406	0.0179 Fraction of 1 Standard Deviation 0.04098	0.0650 Fraction of 1 Standard Deviation 0.05679	0.0607 Fraction of 1 Standard Deviation 0.01793	-0.1180 Fraction of 1 Standard Deviation 0.26962	0.0320 Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day2; n= 32,37,2,2,0,0	-0.0072 Fraction of 1 Standard Deviation 0.02369	-0.0048 Fraction of 1 Standard Deviation 0.02013	-0.0310 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0195 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day3; n= 29,30,1,1,0,0	-0.0129 Fraction of 1 Standard Deviation 0.02555	-0.0046 Fraction of 1 Standard Deviation 0.02342	-0.0090 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0300 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day4; n= 25,26,0,0,0,0	-0.0140 Fraction of 1 Standard Deviation 0.02358	-0.0107 Fraction of 1 Standard Deviation 0.02226	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day5; n= 22,23,0,0,0,0	-0.0085 Fraction of 1 Standard Deviation 0.02886	-0.0064 Fraction of 1 Standard Deviation 0.02956	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day6; n= 17,19,0,0,0,0	-0.0152 Fraction of 1 Standard Deviation 0.03950	-0.0088 Fraction of 1 Standard Deviation 0.03036	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Day7; n= 14,15,0,0,0,0	-0.0148 Fraction of 1 Standard Deviation 0.04008	-0.0145 Fraction of 1 Standard Deviation 0.03551	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available
Change From Baseline in Hematocrit Level Intolerance Day2; n= 0,0,3,3,4,4	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0017 Fraction of 1 Standard Deviation 0.02438	-0.0287 Fraction of 1 Standard Deviation 0.02203	-0.1385 Fraction of 1 Standard Deviation 0.26790	-0.0113 Fraction of 1 Standard Deviation 0.00699
Change From Baseline in Hematocrit Level Intolerance Day4; n= 0,0,2,2,3,3	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0050 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0350 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.1803 Fraction of 1 Standard Deviation 0.29416	0.0030 Fraction of 1 Standard Deviation 0.01836
Change From Baseline in Hematocrit Level Intolerance Day5; n= 0,0,2,1,3,3	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0350 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0200 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.1963 Fraction of 1 Standard Deviation 0.29767	0.0213 Fraction of 1 Standard Deviation 0.01474
Change From Baseline in Hematocrit Level Intolerance Day6; n= 0,0,2,1,3,2	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	NA Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0320 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.0200 Fraction of 1 Standard Deviation NA NA indicates that the data was not available	-0.1617 Fraction of 1 Standard Deviation 0.30168	-0.0030 Fraction of 1 Standard Deviation NA NA indicates that the data was not available

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day3; n= 28,30,1,1,0,0	0.13 Femtoliter (fL) Standard Deviation 1.431	0.40 Femtoliter (fL) Standard Deviation 1.627	3.90 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	0.00 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-2.47 Femtoliter (fL) Standard Deviation 3.101	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Follow up; n= 23,27,3,3,4,2	-0.24 Femtoliter (fL) Standard Deviation 3.394	1.46 Femtoliter (fL) Standard Deviation 4.280	4.57 Femtoliter (fL) Standard Deviation 3.774	-2.93 Femtoliter (fL) Standard Deviation 0.902	-0.77 Femtoliter (fL) Standard Deviation 5.557	4.00 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day4; n= 25,26,0,0,0,0	-0.14 Femtoliter (fL) Standard Deviation 2.108	0.79 Femtoliter (fL) Standard Deviation 2.017	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-2.53 Femtoliter (fL) Standard Deviation 2.194	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day2; n= 31,37,2,2,0,0	0.36 Femtoliter (fL) Standard Deviation 1.349	0.14 Femtoliter (fL) Standard Deviation 1.478	1.70 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-0.50 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-0.60 Femtoliter (fL) Standard Deviation 0.876	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day5; n= 22,23,0,0,0,0	0.09 Femtoliter (fL) Standard Deviation 2.661	0.40 Femtoliter (fL) Standard Deviation 2.042	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-1.10 Femtoliter (fL) Standard Deviation 3.804	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day6; n= 17,19,0,0,0,0	0.17 Femtoliter (fL) Standard Deviation 3.098	0.53 Femtoliter (fL) Standard Deviation 2.515	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-2.20 Femtoliter (fL) Standard Deviation 5.800	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Day7; n= 14,15,0,0,0,0	1.04 Femtoliter (fL) Standard Deviation 3.680	-0.01 Femtoliter (fL) Standard Deviation 2.669	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-1.13 Femtoliter (fL) Standard Deviation 5.244	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day1; n= 1,0,2,3,0,0	0.50 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	3.10 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-1.10 Femtoliter (fL) Standard Deviation 0.854	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day2; n= 0,0,3,3,4,4	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	3.43 Femtoliter (fL) Standard Deviation 3.182	0.00 Femtoliter (fL) Standard Deviation 1.732	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	0.92 Femtoliter (fL) Standard Deviation 1.187
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day3; n= 0,0,2,3,3,4	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	1.30 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-1.20 Femtoliter (fL) Standard Deviation 1.709	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	0.27 Femtoliter (fL) Standard Deviation 2.968
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day4; n= 0,0,2,2,3,3	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	3.05 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-1.10 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	2.30 Femtoliter (fL) Standard Deviation 4.107
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day5; n= 0,0,2,1,3,3	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	2.90 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	0.10 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	3.13 Femtoliter (fL) Standard Deviation 5.169
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day6; n= 0,0,2,1,3,2	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	3.95 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	-0.20 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	5.60 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Volume (MCV) Levels Intolerance Day7; n= 0,01,0,3,2	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	5.10 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	NA Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.	4.15 Femtoliter (fL) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day6; n= 17,19,0,0,0,0	-0.176 Tetra unit per liter (TI/L) Standard Deviation 0.4999	-0.118 Tetra unit per liter (TI/L) Standard Deviation 0.3403	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day7; n= 14,15,0,0,0,0	-0.202 Tetra unit per liter (TI/L) Standard Deviation 0.4849	-0.149 Tetra unit per liter (TI/L) Standard Deviation 0.3610	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; Day5; n= 0,1,0,0,0,0	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.0010 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; Day7; n= 7,4,0,0,0,0	0.0074 Tetra unit per liter (TI/L) Standard Deviation 0.04599	0.0031 Tetra unit per liter (TI/L) Standard Deviation 0.01158	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0170 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0822 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; follow up; n= 11,11,2,2,3,2	4.1273 Tetra unit per liter (TI/L) Standard Deviation 13.55607	1.6622 Tetra unit per liter (TI/L) Standard Deviation 5.41884	0.0847 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0537 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0870 Tetra unit per liter (TI/L) Standard Deviation 0.02364	0.0569 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day2; n= 32,37,2,2,0,0	-0.098 Tetra unit per liter (TI/L) Standard Deviation 0.2816	-0.059 Tetra unit per liter (TI/L) Standard Deviation 0.2262	-0.375 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.150 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day3; n= 29,30,1,1,0,0	-0.163 Tetra unit per liter (TI/L) Standard Deviation 0.3001	-0.067 Tetra unit per liter (TI/L) Standard Deviation 0.2776	-0.210 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.200 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day4; n= 25,26,0,0,0,0	-0.155 Tetra unit per liter (TI/L) Standard Deviation 0.3038	-0.141 Tetra unit per liter (TI/L) Standard Deviation 0.2417	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; Day5; n= 22,23,0,0,0,0	-0.099 Tetra unit per liter (TI/L) Standard Deviation 0.3676	-0.085 Tetra unit per liter (TI/L) Standard Deviation 0.3246	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day1; n= 1,0,2,3,0,0	-0.540 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.120 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.077 Tetra unit per liter (TI/L) Standard Deviation 0.0586	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day2; n= 0,0,3,3,4,4	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.113 Tetra unit per liter (TI/L) Standard Deviation 0.1701	-0.293 Tetra unit per liter (TI/L) Standard Deviation 0.2335	0.018 Tetra unit per liter (TI/L) Standard Deviation 0.1228	-0.172 Tetra unit per liter (TI/L) Standard Deviation 0.1159
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day3; n= 0,0,2,3,3,4	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.390 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.333 Tetra unit per liter (TI/L) Standard Deviation 0.1563	-0.030 Tetra unit per liter (TI/L) Standard Deviation 0.2042	-0.105 Tetra unit per liter (TI/L) Standard Deviation 0.1511
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day4; n= 0,0,2,2,3,3	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.165 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.270 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.047 Tetra unit per liter (TI/L) Standard Deviation 0.3075	-0.050 Tetra unit per liter (TI/L) Standard Deviation 0.2390
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day5; n= 0,0,2,1,3,3	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.495 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.150 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.157 Tetra unit per liter (TI/L) Standard Deviation 0.3371	0.133 Tetra unit per liter (TI/L) Standard Deviation 0.0306
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day6; n= 0,0,2,1,3,2	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.505 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.130 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.267 Tetra unit per liter (TI/L) Standard Deviation 0.3055	-0.170 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC; intolerance Day7; n= 0,0,1,0,3,2	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	-0.400 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.150 Tetra unit per liter (TI/L) Standard Deviation 0.2598	-0.250 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count RBC follow up; n= 24,28,3,3,4,2	0.195 Tetra unit per liter (TI/L) Standard Deviation 0.6553	0.142 Tetra unit per liter (TI/L) Standard Deviation 0.4196	0.577 Tetra unit per liter (TI/L) Standard Deviation 0.4826	0.790 Tetra unit per liter (TI/L) Standard Deviation 0.1493	0.188 Tetra unit per liter (TI/L) Standard Deviation 0.3636	0.170 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; Day6; n= 0,1,0,0,0,0	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0810 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0530 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0080 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	0.0340 Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.	NA Tetra unit per liter (TI/L) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: Up to 23 days

Population: Safety Population.

Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

Outcome measures

Measure	Camicinal 50 mg n=35 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=39 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 Participants Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day2; n= 27,35,2,1,0,0	0.01 Picogram (PG) Standard Deviation 0.522	0.02 Picogram (PG) Standard Deviation 0.531	0.35 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	0.00 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day3; n= 24,28,1,0,0,0	-0.10 Picogram (PG) Standard Deviation 0.581	-0.08 Picogram (PG) Standard Deviation 0.547	0.20 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day5; n= 19,21,0,0,0,0	-0.23 Picogram (PG) Standard Deviation 0.628	-0.44 Picogram (PG) Standard Deviation 0.494	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day6; n= 15,17,0,0,0,0	-0.15 Picogram (PG) Standard Deviation 0.505	-0.41 Picogram (PG) Standard Deviation 0.431	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day7; n= 12,14,0,0,0,0	-0.02 Picogram (PG) Standard Deviation 0.488	-0.45 Picogram (PG) Standard Deviation 0.435	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day1; n= 1,0,2,2,0,0	0.20 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.65 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.30 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day2; n= 0,0,3,2,3,3	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.57 Picogram (PG) Standard Deviation 1.060	-0.10 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.23 Picogram (PG) Standard Deviation 0.681	-0.10 Picogram (PG) Standard Deviation 0.265
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day5; n= 0,0,2,1,2,2	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	0.45 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.50 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-1.00 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.30 Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day6; n= 0,0,2,1,2,1	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	0.20 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-1.10 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-1.00 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.70 Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Day4; n= 21,24,0,0,0,0	-0.26 Picogram (PG) Standard Deviation 0.685	-0.24 Picogram (PG) Standard Deviation 0.690	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day3; n= 0,0,2,2,2,3	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.10 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.10 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.65 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.27 Picogram (PG) Standard Deviation 0.153
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day4; n= 0,0,2,1,2,2	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.10 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.60 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.75 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.50 Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Intolerance Day7; n= 0,0,1,0,2,1	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.50 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	NA Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.75 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	0.40 Picogram (PG) Standard Deviation NA NA indicates that data were not available.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Follow up; n= 21,26,3,2,3,2	-0.40 Picogram (PG) Standard Deviation 0.889	-0.20 Picogram (PG) Standard Deviation 0.944	-0.50 Picogram (PG) Standard Deviation 1.652	-2.15 Picogram (PG) Standard Deviation NA NA indicates that data were not available.	-0.50 Picogram (PG) Standard Deviation 0.800	-0.90 Picogram (PG) Standard Deviation NA NA indicates that data were not available.

SECONDARY outcome

Timeframe: At Day 2

Population: ITT (exposed) Population.

Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) Cmax; post-dose; n= 33,27	6576.47 Log [nanogram per milliliter (ng/mL)] Interval 5123.54 to 8441.42	6319.73 Log [nanogram per milliliter (ng/mL)] Interval 5251.08 to 7605.87	—	—	—	—
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) C60; Pre-dose; n= 42,36	4108.99 Log [nanogram per milliliter (ng/mL)] Interval 3357.46 to 5028.74	4374.35 Log [nanogram per milliliter (ng/mL)] Interval 3157.08 to 6060.97	—	—	—	—
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) C60; post-dose; n= 33,27	4504.30 Log [nanogram per milliliter (ng/mL)] Interval 3428.13 to 5918.29	4691.64 Log [nanogram per milliliter (ng/mL)] Interval 3917.56 to 5618.66	—	—	—	—
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) Cmax; pre-dose; n= 42,36	5482.09 Log [nanogram per milliliter (ng/mL)] Interval 4529.01 to 6635.72	6068.34 Log [nanogram per milliliter (ng/mL)] Interval 4428.15 to 8316.07	—	—	—	—

SECONDARY outcome

Timeframe: At Day 2

Population: ITT (exposed) Population.

Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed AUC[0-60] of Acetaminophen Pre-dose; n=42,36	192321.7 Log [min into ng/mL (min*ng/mL)] Interval 153049.5 to 241671.0	222411.3 Log [min into ng/mL (min*ng/mL)] Interval 161086.4 to 307082.4	—	—	—	—
Log Transformed AUC[0-60] of Acetaminophen Post-dose; n= 33,27	234538.9 Log [min into ng/mL (min*ng/mL)] Interval 174645.6 to 314972.3	228473.7 Log [min into ng/mL (min*ng/mL)] Interval 185338.9 to 281647.5	—	—	—	—

SECONDARY outcome

Timeframe: At Day 2

Population: ITT (exposed) Population.

Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) Post-dose; n= 32,27	7.2872 Log [Min. into mmol/L (min*mmol/l)] Interval 5.9044 to 8.9938	6.1047 Log [Min. into mmol/L (min*mmol/l)] Interval 4.3137 to 8.6394	—	—	—	—
Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) Pre-dose; n=38,34	3.3709 Log [Min. into mmol/L (min*mmol/l)] Interval 2.2283 to 5.0993	3.8341 Log [Min. into mmol/L (min*mmol/l)] Interval 2.5286 to 5.8136	—	—	—	—

SECONDARY outcome

Timeframe: At Day 2

Population: ITT (exposed) Population.

Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed C60 of 3-OMG C60; Pre-dose	0.12547 Log (mmol/L) Interval 0.09174 to 0.17159	0.12856 Log (mmol/L) Interval 0.09001 to 0.18362	—	—	—	—
Log Transformed C60 of 3-OMG C60; post-dose	0.19960 Log (mmol/L) Interval 0.15935 to 0.25	0.18723 Log (mmol/L) Interval 0.13985 to 0.25065	—	—	—	—

SECONDARY outcome

Timeframe: At Day 2

Population: PK Population. Data for Tmax was not collected.

Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population. Two participants in the camicinal group and one participant in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.

Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.

Outcome measures

Measure	Camicinal 50 mg n=40 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=37 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Percentage of Participants That Became Intolerant	15 Percentage of participants	14 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population. Two subjects in the Camicinal group and one subject in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.

Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.

Outcome measures

Measure	Camicinal 50 mg n=40 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=37 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Time to Development of Feeding Intolerance	102.9 Hr Standard Error 5.39	108.0 Hr Standard Error 6.26	—	—	—	—

SECONDARY outcome

Timeframe: Day 2

Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.

GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=36 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen	192321.7 min*ng/mL Interval 153049.5 to 241671.0	222411.3 min*ng/mL Interval 161086.4 to 307082.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 2, Day 3, Day 4

Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.

GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=36 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen	5482.09 ng/mL Interval 4529.01 to 6635.72	6068.34 ng/mL Interval 4428.15 to 8316.07	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 2, Day 3, Day 4

Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed (represented by n=X in the category titles).

GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

Outcome measures

Measure	Camicinal 50 mg n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=34 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG AUC(0-60); n= 38, 34	3.3709 min*mmol/l Interval 2.2283 to 5.0993	3.8341 min*mmol/l Interval 2.5286 to 5.8136	—	—	—	—
GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG AUC(0-240); n= 36, 33	31.4065 min*mmol/l Interval 23.7921 to 41.4578	26.4060 min*mmol/l Interval 17.8925 to 38.9703	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 2, Day 3, Day 4

Population: ITT (exposed) Population. Only those participants available at the pre-dose visit were analyzed.

GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

Outcome measures

Measure	Camicinal 50 mg n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=34 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG	0.12547 mmol/l Interval 0.09174 to 0.17159	0.12856 mmol/l Interval 0.09001 to 0.18362	—	—	—	—

SECONDARY outcome

Timeframe: up to 23 days

Population: Enrolled Population

The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.

Outcome measures

Measure	Camicinal 50 mg n=40 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=44 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=4 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=4 Participants Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes Vomiting	6 Participants	7 Participants	0 Participants	1 Participants	—	—
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes Macroaspiration	0 Participants	1 Participants	1 Participants	0 Participants	—	—
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes Regurgitation	1 Participants	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 7

Population: ITT (exposed) Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo n=38 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Total GRV for 24 hr Period Day 1; n= 36,34	37.2 mL Standard Deviation 64.64	92.7 mL Standard Deviation 184.83	—	—	—	—
Total GRV for 24 hr Period Day 2; n= 34,32	118.5 mL Standard Deviation 290.26	191.6 mL Standard Deviation 259.93	—	—	—	—
Total GRV for 24 hr Period Day 3; n= 29,26	169.7 mL Standard Deviation 259.73	143.3 mL Standard Deviation 258.46	—	—	—	—
Total GRV for 24 hr Period Day 4; n= 23,22	131.9 mL Standard Deviation 178.71	83.3 mL Standard Deviation 106.55	—	—	—	—
Total GRV for 24 hr Period Day 5; n= 19,19	185.2 mL Standard Deviation 312.93	97.5 mL Standard Deviation 150.45	—	—	—	—
Total GRV for 24 hr Period Day 6; n= 15,15	180.0 mL Standard Deviation 313.03	135.7 mL Standard Deviation 285.43	—	—	—	—
Total GRV for 24 hr Period Day 7; n= 12,10	85.6 mL Standard Deviation 155.67	60.2 mL Standard Deviation 45.66	—	—	—	—

SECONDARY outcome

Timeframe: Day 2, Day 3, Day 4, Day 7

Population: PK Population.

Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

Outcome measures

Measure	Camicinal 50 mg n=42 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance Day 2; n= 25	952.55 Log (ng/mL) Interval 740.67 to 1225.04	—	—	—	—	—
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance Day 3; n=3	748.28 Log (ng/mL) Interval 87.38 to 6408.21	—	—	—	—	—
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance Day 4; n= 5	1722.74 Log (ng/mL) Interval 1167.35 to 2542.38	—	—	—	—	—
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance Day 7; n= 5	1206.67 Log (ng/mL) Interval 753.77 to 1931.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 4

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.

Outcome measures

Measure	Camicinal 50 mg n=7 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance Intolerance Day 2; n= 2	168.56 Log (ng/mL) NA indicates that the data were not available.	—	—	—	—	—
Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance Intolerance Day 4; n= 1	704.40 Log (ng/mL) NA indicates that the data were not available.	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 4

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.

Outcome measures

Measure	Camicinal 50 mg n=7 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Derived Tmax of GSK962040 Post Intolerance Intolerance Day 2; n= 2	2.717 Hr Interval 1.93 to 3.5	—	—	—	—	—
Derived Tmax of GSK962040 Post Intolerance Intolerance day 4; n= 1	1.500 Hr Interval 1.5 to 1.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 4

Population: PK Population.

Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.

Outcome measures

Measure	Camicinal 50 mg n=1 Participants EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.	Placebo EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.	Baseline EN Tolerant: Placebo/Camicinal 50 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance Intolerance Day 2	792.8 min*mmol/l Standard Deviation NA SD was not provided if n\<3	—	—	—	—	—
Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance Intolerance Day 4	2698.8 min*mmol/l Standard Deviation NA SD was not provided if n\<3	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 2, Day 3, Day 4

Population: PK Population. data were not collected.

To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.

Outcome measures

Outcome data not reported

Adverse Events

Baseline EN Tolerant: Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Baseline EN Tolerant: Camicinal 50 mg

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Baseline EN Tolerant: Placebo/Camicinal 50 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Baseline EN Intolerant: Camicinal 50 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Baseline EN Intolerant: Metoclopramide 10 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Baseline EN Tolerant: Placebo n=35 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.	Baseline EN Tolerant: Camicinal 50 mg n=39 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 participants at risk Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 participants at risk Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Intestinal ischaemia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.

Other adverse events

Measure	Baseline EN Tolerant: Placebo n=35 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.	Baseline EN Tolerant: Camicinal 50 mg n=39 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.	Baseline EN Tolerant: Placebo/Camicinal 50 mg n=3 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.	Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg n=3 participants at risk Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.	Baseline EN Intolerant: Camicinal 50 mg n=4 participants at risk Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.	Baseline EN Intolerant: Metoclopramide 10 mg n=4 participants at risk Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Investigations Blood potassium decreased	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Blood urea increased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Body temperature increased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Blood glucose increased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	7.7% 3/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	66.7% 2/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	66.7% 2/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diverticulum	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastric dilatation	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Haematochezia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Intestinal ischaemia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Enterococcal infection	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Escherichia infection	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Klebsiella sepsis	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Oral candidiasis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Oral herpes	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia haemophilus	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Pulmonary sepsis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal sepsis	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Streptococcal infection	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Infections and infestations Wound infection	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Electrocardiogram ST segment depression	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Electrocardiogram T wave inversion	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Haemoglobin decreased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Investigations Liver function test increased	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cheyne-Stokes respiration	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Atrial flutter	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Atrial tachycardia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Bundle branch block right	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Tachycardia paroxysmal	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Fluid overload	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Psychiatric disorders Delirium	5.7% 2/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	7.7% 3/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	25.0% 1/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural haemorrhage	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin graft failure	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Erythema	5.7% 2/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	5.1% 2/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Vascular disorders Deep vein thrombosis	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Vascular disorders Hypotension	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholestasis	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Surgical and medical procedures Device dislocation	2.9% 1/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/35 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	2.6% 1/39 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.	0.00% 0/4 • Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose. AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.

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