Trial Outcomes & Findings for A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (NCT NCT02013050)

NCT ID: NCT02013050

Last Updated: 2017-08-28

Results Overview

Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 111 participants
• Primary outcome timeframe: 4 weeks after end of therapy
• Results posted on: 2017-08-28

Participant Flow

Two patients were randomized but never received study drug and are excluded from the analyses

Participant milestones

Measure	Placebo Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses	1.5 mg/kg Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses	3.0 mg/kg Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses	6.0 mg/kg Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
Overall Study STARTED	42	41	3	23
Overall Study COMPLETED	38	36	3	19
Overall Study NOT COMPLETED	4	5	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

Baseline characteristics by cohort

Measure	Placebo n=42 Participants	1.5 mg/kg n=41 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=23 Participants	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	2 Participants n=5 Participants	20 Participants n=4 Participants	84 Participants n=21 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	25 Participants n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	32 Participants n=7 Participants	1 Participants n=5 Participants	20 Participants n=4 Participants	86 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	38 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants	101 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	36 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants	97 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	42 participants n=5 Participants	41 participants n=7 Participants	3 participants n=5 Participants	23 participants n=4 Participants	109 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks after end of therapy

Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Duration of Severe Oral Mucositis (SOM)	18 days Interval 5.0 to 36.0	9 days Interval 3.0 to 19.0	14 days Interval 0.0 to The sample size does not allow	22 days Interval 3.0 to 36.0

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Residual Severe Oral Mucositis (SOM)	21 percentage of participants	6 percentage of participants	33 percentage of participants	16 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Duration of Severe Oral Mucositis (SOM)	35.5 WHO score * days Interval 0.0 to 222.0	21.8 WHO score * days Interval 0.0 to 210.0	33.0 WHO score * days Interval 0.0 to 84.0	46.5 WHO score * days Interval 0.0 to 167.0

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Incidence of Clinically Reported, Non-fungal Infections	45 percentage of participants	28 percentage of participants	0 percentage of participants	21 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:

Target Lesion :

Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR

Non-Target Lesion:

Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Percent of Patients With RECIST 1.1 Classification of "Complete Response"	39 percentage of participants	47 percentage of participants	33 percentage of participants	21 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

Outcome measures

Measure	Placebo n=22 Participants	1.5 mg/kg n=24 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=10 Participants
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin	30 days Interval 5.0 to 65.0	10 days Interval 0.0 to 19.0	14 days Interval 0.0 to The sample size does not allow	17 days Interval 0.0 to The sample size does not allow

SECONDARY outcome

Timeframe: 4 weeks after end of therapy

Outcome measures

Measure	Placebo n=22 Participants	1.5 mg/kg n=24 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=10 Participants
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin	82 percentage of participants	67 percentage of participants	67 percentage of participants	80 percentage of participants

SECONDARY outcome

Timeframe: 12 months after end of therapy

Population: Safety Population: all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug that they actually received instead of the drug dose they were randomized. 2 patients were randomized but never received drug and are excluded. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942.

Outcome measures

Measure	Placebo n=43 Participants	1.5 mg/kg n=41 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=24 Participants
Survival	81 percentage of participants	93 percentage of participants	100 percentage of participants	83 percentage of participants

SECONDARY outcome

Timeframe: 12 months after end of therapy

The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:

Target Lesion :

Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR

Non-Target Lesion:

Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions

Outcome measures

Measure	Placebo n=38 Participants	1.5 mg/kg n=36 Participants	3.0 mg/kg n=3 Participants	6.0 mg/kg n=19 Participants
Percent of Patients With RECIST 1.1 Classification of "Complete Response"	53 percentage of participants	53 percentage of participants	33 percentage of participants	53 percentage of participants

Adverse Events

Placebo

Serious events: 25 serious events

Other events: 41 other events

Deaths: 8 deaths

1.5 mg/kg

Serious events: 25 serious events

Other events: 42 other events

Deaths: 3 deaths

3.0 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

6.0 mg/kg

Serious events: 16 serious events

Other events: 23 other events

Deaths: 4 deaths

Serious adverse events

Measure	Placebo n=41 participants at risk	1.5 mg/kg n=42 participants at risk	3.0 mg/kg n=3 participants at risk	6.0 mg/kg n=23 participants at risk
Blood and lymphatic system disorders Anaemia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Pancytopenia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Cardiac disorders Tachycardia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Constipation	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Dysphagia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Nausea	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Rectal haemorrhage	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Vomiting	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Disease progression	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Non-cardiac chest pain	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Pyrexia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Cellulitis	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Device related infection	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Empyema	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Infection	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Lobar pneumonia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Pneumonia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Pneumonia klebsiella	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Post procedural infection	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Sepsis	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Staphylococcal bacteraemia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Staphylococcal sepsis	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Urinary tract infection	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Injury, poisoning and procedural complications Feeding tube complication	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Injury, poisoning and procedural complications Wound complication	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Dehydration	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hyponatraemia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypovolaemia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Malnutrition	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Dysgeusia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Syncope	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Psychiatric disorders Mental status changes	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Renal disorder	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Renal failure acute	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Urinary retention	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Deep vein thrombosis	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Embolism	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Hypotension	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Peripheral artery thrombosis	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.

Other adverse events

Measure	Placebo n=41 participants at risk	1.5 mg/kg n=42 participants at risk	3.0 mg/kg n=3 participants at risk	6.0 mg/kg n=23 participants at risk
Infections and infestations Urinary tract infection	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Anaemia	12.2% 5/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	31.0% 13/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.1% 6/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Blood disorder	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Neutropenia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Neutrophil function disorder	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Platelet disorder	12.2% 5/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	16.7% 7/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Blood and lymphatic system disorders White blood cell disorder	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	38.1% 16/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.1% 6/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Cardiac disorders Atrial fibrillation	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Cardiac disorders Tachycardia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Ear and labyrinth disorders Hearing impaired	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Ear and labyrinth disorders Tinnitus	22.0% 9/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	14.3% 6/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	21.7% 5/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Constipation	56.1% 23/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	42.9% 18/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	47.8% 11/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Diarrhea	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	23.8% 10/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Dry mouth	26.8% 11/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 14/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	30.4% 7/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Dyspepsia	17.1% 7/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Dysphagia	26.8% 11/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 14/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	100.0% 3/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.1% 6/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Gingival pain	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Nausea	70.7% 29/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	73.8% 31/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	100.0% 3/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	87.0% 20/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Odynophagia	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	14.3% 6/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Oesophagitis	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Oral pain	24.4% 10/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Saliva altered	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Salivary duct inflammation	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Gastrointestinal disorders Vomiting	36.6% 15/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	54.8% 23/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	52.2% 12/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Asthenia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Chills	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Fatigue	51.2% 21/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	54.8% 23/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	52.2% 12/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Malaise	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Medical device complication	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Oedema peripheral	12.2% 5/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
General disorders Pyrexia	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	28.6% 12/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Hepatobiliary disorders Hepatic function abnormal	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Candida infection	17.1% 7/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	19.0% 8/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Fungal infection	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Oral candidiasis	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	28.6% 12/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Infections and infestations Pneumonia	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Injury, poisoning and procedural complications Radiation skin injury	24.4% 10/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 14/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.1% 6/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Abnormal loss of weight	19.5% 8/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	31.0% 13/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	43.5% 10/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Decreased appetite	29.3% 12/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	23.8% 10/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	39.1% 9/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Dehydration	24.4% 10/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	40.5% 17/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	30.4% 7/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.1% 6/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypertriglyceridaemia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hyperuricaemia	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypoalbuminaemia	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	16.7% 7/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypocalcaemia	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	16.7% 7/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypoglycaemia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypokalaemia	12.2% 5/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	26.2% 11/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypomagnesaemia	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	23.8% 10/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hyponatraemia	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	21.4% 9/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Hypophosphataemia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Metabolism and nutrition disorders Malnutrition	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Musculoskeletal and connective tissue disorders Neck pain	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Musculoskeletal and connective tissue disorders Trismus	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Ageusia	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Dizziness	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	19.0% 8/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	13.0% 3/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Dysgeusia	26.8% 11/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	52.4% 22/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	56.5% 13/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Headache	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	28.6% 12/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Nervous system disorders Syncope	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Psychiatric disorders Anxiety	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Psychiatric disorders Confusional state	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Psychiatric disorders Depression	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Psychiatric disorders Insomnia	14.6% 6/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	21.7% 5/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Proteinuria	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Renal disorder	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	16.7% 7/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Renal and urinary disorders Renal failure acute	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	7.1% 3/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 1/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Hiccups	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	19.5% 8/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	40.5% 17/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	66.7% 2/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	34.8% 8/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Dermatitis	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	9.5% 4/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	17.4% 4/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Erythema	12.2% 5/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	14.3% 6/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Pruritus	9.8% 4/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.8% 2/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Rash	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	2.4% 1/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Skin and subcutaneous tissue disorders Skin exfoliation	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	11.9% 5/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Hypertension	7.3% 3/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	16.7% 7/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	33.3% 1/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	8.7% 2/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
Vascular disorders Hypotension	4.9% 2/41 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	14.3% 6/42 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	0.00% 0/3 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.	4.3% 1/23 • From the time of enrollment up until four weeks (±5 days) following the last study drug treatment. Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.

Additional Information

Dr. Richard Straube

Soligenix, Inc.

Email: rstraube@soligenix.com

Results disclosure agreements

• Principal investigator is a sponsor employee There were limitations put on the sites from publishing data until the sponsor had published data. That data is now published.
• Publication restrictions are in place

Restriction type: OTHER