Trial Outcomes & Findings for A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (NCT NCT01561053)

Last Updated: 2019-07-31

Results Overview

ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

347 participants

Primary outcome timeframe

Baseline and 14 months

Results posted on

2019-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	High Albumin + Immunoglobulin Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group Simulated plasma exchange procedure
Overall Study STARTED	86	92	82	87
Overall Study Patients With Baseline MMSE:18-21	47	40	47	42
Overall Study Patients With Baseline MMSE:22-26	39	52	35	45
Overall Study Randomized Not Treated	8	6	4	7
Overall Study Evaluable Subjects	78	86	78	80
Overall Study COMPLETED	51	56	61	64
Overall Study NOT COMPLETED	35	36	21	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Albumin + Immunoglobulin n=78 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=86 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=78 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=80 Participants Simulated plasma exchange procedure	Total n=322 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=78 Participants	0 Participants n=86 Participants	0 Participants n=78 Participants	0 Participants n=80 Participants	0 Participants n=322 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=78 Participants	17 Participants n=86 Participants	26 Participants n=78 Participants	29 Participants n=80 Participants	94 Participants n=322 Participants
Age, Categorical >=65 years	56 Participants n=78 Participants	69 Participants n=86 Participants	52 Participants n=78 Participants	51 Participants n=80 Participants	228 Participants n=322 Participants
Age, Continuous	69.54 years STANDARD_DEVIATION 7.895 • n=78 Participants	69.47 years STANDARD_DEVIATION 6.924 • n=86 Participants	68.47 years STANDARD_DEVIATION 7.476 • n=78 Participants	68.44 years STANDARD_DEVIATION 8.378 • n=80 Participants	68.99 years STANDARD_DEVIATION 7.655 • n=322 Participants
Sex: Female, Male Female	47 Participants n=78 Participants	48 Participants n=86 Participants	43 Participants n=78 Participants	36 Participants n=80 Participants	174 Participants n=322 Participants
Sex: Female, Male Male	31 Participants n=78 Participants	38 Participants n=86 Participants	35 Participants n=78 Participants	44 Participants n=80 Participants	148 Participants n=322 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Baseline Mini-Mental State Examination total score	21.41 units on a scale STANDARD_DEVIATION 2.616 • n=78 Participants	22.09 units on a scale STANDARD_DEVIATION 2.633 • n=86 Participants	21.24 units on a scale STANDARD_DEVIATION 2.408 • n=78 Participants	21.69 units on a scale STANDARD_DEVIATION 2.559 • n=80 Participants	21.62 units on a scale STANDARD_DEVIATION 2.566 • n=322 Participants

PRIMARY outcome

Timeframe: Baseline and 14 months

Population: Evaluable population with ADAS-Cog measurement at 14 months

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=50 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=57 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=61 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=64 Participants Simulated plasma exchange procedure	All Treated n=168 Participants All patients Treatment groups 1, 2 and 3 combined
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months)	0.8 units on a scale Standard Error 1.28	0.8 units on a scale Standard Error 1.09	1.5 units on a scale Standard Error 1.02	3.2 units on a scale Standard Error 0.95	1.0 units on a scale Standard Error 0.64

PRIMARY outcome

Timeframe: Baseline and 14 Months

Population: Evaluable population with ADCS-ADL measurement at 14 months

ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=51 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=57 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=61 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=64 Participants Simulated plasma exchange procedure	All Treated n=169 Participants All patients Treatment groups 1, 2 and 3 combined
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months)	-3.5 units on a scale Standard Error 1.80	-2.0 units on a scale Standard Error 1.03	-3.9 units on a scale Standard Error 1.24	-6.7 units on a scale Standard Error 1.50	-3.2 units on a scale Standard Error 0.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 14 months

Population: Evaluable population with baseline MMSE:22-26 and with ADAS-Cog measurement at 14 months

ADAS-Cog total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=23 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=37 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=25 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=38 Participants Simulated plasma exchange procedure	All Treated n=85 Participants All patients Treatment groups 1, 2 and 3 combined
ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26	-0.9 units on a scale Standard Error 1.51	-0.3 units on a scale Standard Error 1.04	-0.6 units on a scale Standard Error 1.12	0.6 units on a scale Standard Error 1.12	-0.6 units on a scale Standard Error 0.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 14 months

Population: Evaluable population with baseline MMSE:22-26 and with ADCS-ADL measurement at 14 months

ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=23 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=37 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=25 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=38 Participants Simulated plasma exchange procedure	All Treated n=85 Participants All patients Treatment groups 1, 2 and 3 combined
ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26	-2.4 units on a scale Standard Error 1.68	0.8 units on a scale Standard Error 0.98	-0.9 units on a scale Standard Error 1.43	-1.3 units on a scale Standard Error 1.29	-0.6 units on a scale Standard Error 0.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 14 months

Population: Evaluable population with baseline MMSE:18-21 and with ADAS-Cog measurement at 14 months

ADAS-Cog score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=27 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=20 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=36 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=26 Participants Simulated plasma exchange procedure	All Treated n=83 Participants All patients Treatment groups 1, 2 and 3 combined
ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21	2.4 units on a scale Standard Error 1.95	1.9 units on a scale Standard Error 2.44	3.3 units on a scale Standard Error 1.49	6.4 units on a scale Standard Error 1.34	2.6 units on a scale Standard Error 1.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 14 months

Population: Evaluable population with baseline MMSE:18-21 and with ADCS-ADL measurement at 14 months

ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).

Outcome measures

Outcome measures
Measure	High Albumin + Immunoglobulin n=28 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=20 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=36 Participants Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=26 Participants Simulated plasma exchange procedure	All Treated n=84 Participants All patients Treatment groups 1, 2 and 3 combined
ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21	-4.5 units on a scale Standard Error 2.97	-5.7 units on a scale Standard Error 2.11	-6.0 units on a scale Standard Error 1.75	-14.1 units on a scale Standard Error 2.67	-5.5 units on a scale Standard Error 1.33

Adverse Events

High Albumin + Immunoglobulin

Serious events: 16 serious events

Other events: 67 other events

Deaths: 0 deaths

Low Albumin + Immunoglobulin

Serious events: 19 serious events

Other events: 77 other events

Deaths: 2 deaths

Low Albumin

Serious events: 8 serious events

Other events: 72 other events

Deaths: 0 deaths

Control (Sham) Group

Serious events: 8 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

AMBAR clinical manager

Grifols

Phone: +34 935712200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A 18-month post-study period is reserved for a joint, multi-center publication of study results. After this period, individual sites may publish results provided that the Sponsor is allowed 60 days to review any proposed publication for removal of confidential, protected, and trademarked material prior to submission with an option to delay publication up to 120 days if needed to protect its interests. The Sponsor shall retain the option to receive acknowledgment for its sponsorship of the study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	High Albumin + Immunoglobulin n=79 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=86 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=78 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=79 participants at risk Simulated plasma exchange procedure
Blood and lymphatic system disorders Anaemia	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Cardiac disorders Myocardial infarction	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Cardiac disorders Sinus tachycardia	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Eye disorders Retinal detachment	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Abdominal pain	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Diarrhoea	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Pancreatitis acute	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Chest pain	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Intentional medical device removal by patient	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Non-cardiac chest pain	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Pyrexia	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Thrombosis in device	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Immune system disorders Anaphylactic reaction	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Bronchitis	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Device related infection	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Device related sepsis	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Diverticulitis	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Endocarditis staphylococcal	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Lobar pneumonia	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Sepsis	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Anaesthetic complication cardiac	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Femur fracture	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Hip fracture	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Humerus fracture	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Post lumbar puncture syndrome	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Procedural intestinal perforation	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Metabolism and nutrition disorders Dehydration	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Amyloid related imaging abnormalities	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Cerebrovascular accident	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Headache	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Lacunar infarction	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Metabolic encephalopathy	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Presyncope	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Syncope	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Transient ischaemic attack	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Psychiatric disorders Completed suicide	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Psychiatric disorders Self injurious behaviour	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).

Other adverse events
Measure	High Albumin + Immunoglobulin n=79 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin + Immunoglobulin n=86 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)	Low Albumin n=78 participants at risk Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)	Control (Sham) Group n=79 participants at risk Simulated plasma exchange procedure
Blood and lymphatic system disorders Anaemia	21.5% 17/79 • Number of events 17 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	19.8% 17/86 • Number of events 19 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	20.5% 16/78 • Number of events 20 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/79 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Blood and lymphatic system disorders Iron deficiency anaemia	6.3% 5/79 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Cardiac disorders Bradycardia	5.1% 4/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.5% 3/86 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Diarrhoea	5.1% 4/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.0% 6/86 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Nausea	6.3% 5/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.8% 5/86 • Number of events 8 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	10.3% 8/78 • Number of events 11 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Gastrointestinal disorders Vomiting	3.8% 3/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.0% 6/86 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	6.4% 5/78 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/79 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Catheter site erythema	3.8% 3/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.5% 3/86 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Device connection issue	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/78 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/79 • Number of events 8 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Extravasation	12.7% 10/79 • Number of events 15 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	8.1% 7/86 • Number of events 13 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	9.0% 7/78 • Number of events 12 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Infusion site extravasation	8.9% 7/79 • Number of events 10 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	2.6% 2/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Oedema peripheral	1.3% 1/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	6.3% 5/79 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Catheter site infection	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Nasopharyngitis	7.6% 6/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.5% 3/86 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	9.0% 7/78 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/79 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Respiratory tract infection	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Upper respiratory tract infection	7.6% 6/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.7% 6/78 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	6.3% 5/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Infections and infestations Urinary tract infection	6.3% 5/79 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.0% 6/86 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/79 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Contusion	3.8% 3/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	10.5% 9/86 • Number of events 10 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Injury, poisoning and procedural complications Vascular access complication	7.6% 6/79 • Number of events 11 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Investigations Blood fibrinogen decreased	3.8% 3/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.8% 5/86 • Number of events 8 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/78 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Musculoskeletal and connective tissue disorders Back Pain	3.8% 3/79 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.5% 3/86 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Musculoskeletal and connective tissue disorders Muscle spasms	22.8% 18/79 • Number of events 34 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.8% 5/86 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	11.5% 9/78 • Number of events 18 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/79 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 4/79 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	2.6% 2/78 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Dizziness	13.9% 11/79 • Number of events 12 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	14.0% 12/86 • Number of events 16 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	10.3% 8/78 • Number of events 10 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/79 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Headache	15.2% 12/79 • Number of events 13 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	9.0% 7/78 • Number of events 9 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	17.7% 14/79 • Number of events 20 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Paraesthesia	6.3% 5/79 • Number of events 12 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	11.5% 9/78 • Number of events 16 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Presyncope	12.7% 10/79 • Number of events 14 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	16.3% 14/86 • Number of events 18 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	10.3% 8/78 • Number of events 9 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Nervous system disorders Syncope	5.1% 4/79 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	4.7% 4/86 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 5 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Psychiatric disorders Anxiety	7.6% 6/79 • Number of events 11 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	2.3% 2/86 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.7% 6/78 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.2% 1/86 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Vascular disorders Haematoma	3.8% 3/79 • Number of events 3 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.8% 5/86 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Vascular disorders Hypertension	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	3.8% 3/78 • Number of events 4 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	6.3% 5/79 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Vascular disorders Hypotension	20.3% 16/79 • Number of events 34 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	18.6% 16/86 • Number of events 39 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	26.9% 21/78 • Number of events 43 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	1.3% 1/79 • Number of events 1 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
Vascular disorders Poor venous access	8.9% 7/79 • Number of events 10 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	7.0% 6/86 • Number of events 7 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	5.1% 4/78 • Number of events 6 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).
General disorders Catheter site pain	2.5% 2/79 • Number of events 2 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/86 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	11.5% 9/78 • Number of events 11 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).	0.00% 0/79 • 14 Months 1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject. Therefore, this subject was considered for evaluable population as control (control group \[n=80\] and high albumin + immunoglobulin group \[n=78\]), but moved to high albumin + immunoglobulin group for safety analysis (control group \[n=79\] and high albumin + immunoglobulin group \[n=79\]).