Trial Outcomes & Findings for Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease (NCT NCT00812565)

NCT ID: NCT00812565

Last Updated: 2014-05-05

Results Overview

For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks
• Results posted on: 2014-05-05

Participant Flow

The first patient was enrolled February 2, 2009. The last patient study visit was September 21, 2010. Patients were enrolled in this study from a variety of settings including private practice clinics and hospitals. There were 12 study sites, 5 in Germany and 7 in the United States.

Qualified patients meeting all inclusion exclusion criteria and providing informed consent were enrolled into the trial.

Participant milestones

Measure	Placebo Every 2 Weeks Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Study STARTED	8	7	7	7	7	7	8	7
Overall Study COMPLETED	5	6	7	5	6	6	8	6
Overall Study NOT COMPLETED	3	1	0	2	1	1	0	1

Reasons for withdrawal

Measure	Placebo Every 2 Weeks Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Study Did Not Receive Study Medication	1	1	0	0	0	0	0	0
Overall Study Adverse Event	0	0	0	2	0	0	0	1
Overall Study Did Not Come to Study Visit	1	0	0	0	0	0	0	0
Overall Study Withdrawal of Consent	1	0	0	0	1	0	0	0
Overall Study Reason Not Specified	0	0	0	0	0	1	0	0

Baseline Characteristics

Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

Baseline characteristics by cohort

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	Total n=55 Participants Total of all reporting groups
Age, Continuous	72.6 Years STANDARD_DEVIATION 9.2 • n=5 Participants	66.8 Years STANDARD_DEVIATION 5.5 • n=7 Participants	68.3 Years STANDARD_DEVIATION 4.2 • n=5 Participants	72.9 Years STANDARD_DEVIATION 5.0 • n=4 Participants	71.4 Years STANDARD_DEVIATION 11.8 • n=21 Participants	74.8 Years STANDARD_DEVIATION 5.5 • n=8 Participants	65.9 Years STANDARD_DEVIATION 10.2 • n=8 Participants	68.4 Years STANDARD_DEVIATION 8.6 • n=24 Participants	70.0 Years STANDARD_DEVIATION 8.1 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	24 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	31 Participants n=42 Participants

PRIMARY outcome

Timeframe: Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion	161.20 (pg/mL)*days Standard Deviation 93.90	-245.67 (pg/mL)*days Standard Deviation 747.58	-122.50 (pg/mL)*days Standard Deviation 478.31	-39.10 (pg/mL)*days Standard Deviation 172.72	510.92 (pg/mL)*days Standard Deviation 2395.80	-83.67 (pg/mL)*days Standard Deviation 957.69	-755.38 (pg/mL)*days Standard Deviation 2232.87	-262.92 (pg/mL)*days Standard Deviation 671.37

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24) Aβ1-42	4.1 pg/mL Standard Deviation 3.8	-2.3 pg/mL Standard Deviation 7.8	-4.5 pg/mL Standard Deviation 6.3	-2.7 pg/mL Standard Deviation 7.6	-2.0 pg/mL Standard Deviation 4.8	-3.5 pg/mL Standard Deviation 5.8	-0.1 pg/mL Standard Deviation 4.4	-7.0 pg/mL Standard Deviation 6.2
Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24) Aβ1-40	27.1 pg/mL Standard Deviation 40.2	5.5 pg/mL Standard Deviation 64.5	-0.3 pg/mL Standard Deviation 22.1	-6.5 pg/mL Standard Deviation 61.4	-6.0 pg/mL Standard Deviation 23.8	-20.3 pg/mL Standard Deviation 29.2	15.7 pg/mL Standard Deviation 29.7	-30.5 pg/mL Standard Deviation 42.3

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)	109.7 RTU Standard Deviation 284.8	74.3 RTU Standard Deviation 35.0	163.9 RTU Standard Deviation 136.6	310.2 RTU Standard Deviation 193.0	-56.3 RTU Standard Deviation 58.3	96.7 RTU Standard Deviation 133.7	256.6 RTU Standard Deviation 214.1	501.3 RTU Standard Deviation 514.6

SECONDARY outcome

Timeframe: Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion	40.70 (pg/mL)*days Standard Deviation 48.54	-8.92 (pg/mL)*days Standard Deviation 61.71	-53.94 (pg/mL)*days Standard Deviation 61.59	-17.00 (pg/mL)*days Standard Deviation 23.67	50.13 (pg/mL)*days Standard Deviation 233.87	-8.98 (pg/mL)*days Standard Deviation 213.29	-191.58 (pg/mL)*days Standard Deviation 456.83	-64.75 (pg/mL)*days Standard Deviation 148.29

SECONDARY outcome

Timeframe: Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion	2829.0 RTU*days Standard Deviation 3957.9	358.3 RTU*days Standard Deviation 435.8	1862.5 RTU*days Standard Deviation 1470.9	2189.6 RTU*days Standard Deviation 2289.3	196.6 RTU*days Standard Deviation 1023.0	849.4 RTU*days Standard Deviation 2313.6	6350.8 RTU*days Standard Deviation 3464.9	8494.9 RTU*days Standard Deviation 2292.4

SECONDARY outcome

Timeframe: Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion Aβ1-40	939.4 pg/mL Standard Deviation 1670.8	266.7 pg/mL Standard Deviation 996.0	10.6 pg/mL Standard Deviation 1104.0	-147.0 pg/mL Standard Deviation 1067.9	42.0 pg/mL Standard Deviation 874.0	561.7 pg/mL Standard Deviation 1195.5	403.9 pg/mL Standard Deviation 588.1	642.2 pg/mL Standard Deviation 1171.3
Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion Aβ1-42	32.4 pg/mL Standard Deviation 67.0	-8.7 pg/mL Standard Deviation 38.2	9.7 pg/mL Standard Deviation 54.7	4.0 pg/mL Standard Deviation 40.3	-5.2 pg/mL Standard Deviation 36.3	18.8 pg/mL Standard Deviation 40.3	10.5 pg/mL Standard Deviation 40.9	24.7 pg/mL Standard Deviation 43.2

SECONDARY outcome

Timeframe: Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion	0.38 RTU Standard Deviation 3.72	0.22 RTU Standard Deviation 1.83	1.86 RTU Standard Deviation 1.93	-0.78 RTU Standard Deviation 1.64	0.15 RTU Standard Deviation 0.29	0.40 RTU Standard Deviation 1.43	1.12 RTU Standard Deviation 1.48	0.74 RTU Standard Deviation 2.32

SECONDARY outcome

Timeframe: Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion Phosphorylated tau	0.60 pg/mL Standard Deviation 7.50	-3.17 pg/mL Standard Deviation 14.66	0.43 pg/mL Standard Deviation 3.60	2.60 pg/mL Standard Deviation 4.98	-1.33 pg/mL Standard Deviation 10.05	3.33 pg/mL Standard Deviation 21.23	-2.50 pg/mL Standard Deviation 8.62	10.17 pg/mL Standard Deviation 19.28
Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion Tau	17.4 pg/mL Standard Deviation 38.6	209.3 pg/mL Standard Deviation 416.0	-3.4 pg/mL Standard Deviation 35.6	-7.8 pg/mL Standard Deviation 51.3	-33.2 pg/mL Standard Deviation 69.7	-141.8 pg/mL Standard Deviation 419.5	1.3 pg/mL Standard Deviation 86.7	131.3 pg/mL Standard Deviation 301.0

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24 Week 12 (n=6,6,7,5,7,6,8,7)	1.5 Units on a scale Standard Deviation 2.1	-2.3 Units on a scale Standard Deviation 3.5	-0.6 Units on a scale Standard Deviation 3.0	-2.0 Units on a scale Standard Deviation 3.1	-0.7 Units on a scale Standard Deviation 3.0	-1.2 Units on a scale Standard Deviation 2.3	-0.3 Units on a scale Standard Deviation 2.8	-0.9 Units on a scale Standard Deviation 2.4
Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24 Week 24 (n=7,6,7,6,6,6,8,6)	-0.7 Units on a scale Standard Deviation 3.0	-2.2 Units on a scale Standard Deviation 4.4	0.6 Units on a scale Standard Deviation 2.5	-1.7 Units on a scale Standard Deviation 2.3	-1.8 Units on a scale Standard Deviation 5.5	-3.2 Units on a scale Standard Deviation 3.3	-1.8 Units on a scale Standard Deviation 1.8	-1.5 Units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer's disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24 Week 12 (n=6,6,7,5,7,6,8,7)	1.11 Units on a scale Standard Deviation 4.10	0.94 Units on a scale Standard Deviation 7.27	-0.86 Units on a scale Standard Deviation 4.75	-0.07 Units on a scale Standard Deviation 4.43	1.52 Units on a scale Standard Deviation 5.67	3.67 Units on a scale Standard Deviation 3.85	1.54 Units on a scale Standard Deviation 6.63	2.28 Units on a scale Standard Deviation 5.06
Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24 Week 24 (n=7,6,7,6,5,6,8,6)	-0.62 Units on a scale Standard Deviation 3.86	2.06 Units on a scale Standard Deviation 3.32	-2.14 Units on a scale Standard Deviation 4.41	3.67 Units on a scale Standard Deviation 4.85	0.93 Units on a scale Standard Deviation 3.29	4.17 Units on a scale Standard Deviation 4.85	3.00 Units on a scale Standard Deviation 9.37	1.89 Units on a scale Standard Deviation 8.71

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24 Week 12 (n=6,6,7,5,7,6,8,7)	6.7 Units on a scale Standard Deviation 4.0	0.0 Units on a scale Standard Deviation 5.4	1.7 Units on a scale Standard Deviation 2.8	-1.2 Units on a scale Standard Deviation 3.5	-0.6 Units on a scale Standard Deviation 8.5	-8.2 Units on a scale Standard Deviation 11.8	1.8 Units on a scale Standard Deviation 5.0	-1.9 Units on a scale Standard Deviation 3.5
Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24 Week 24 (n=7,6,7,6,5,6,8,6)	1.9 Units on a scale Standard Deviation 5.0	-1.5 Units on a scale Standard Deviation 5.2	-4.1 Units on a scale Standard Deviation 6.6	-6.5 Units on a scale Standard Deviation 9.7	-1.8 Units on a scale Standard Deviation 6.0	-4.3 Units on a scale Standard Deviation 14.4	1.5 Units on a scale Standard Deviation 8.2	-1.2 Units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24 Week 24 (n=7,6,7,6,5,6,8,6)	-0.57 Units on a scale Standard Deviation 1.57	0.92 Units on a scale Standard Deviation 2.15	0.14 Units on a scale Standard Deviation 1.28	1.25 Units on a scale Standard Deviation 1.97	-1.50 Units on a scale Standard Deviation 2.55	0.83 Units on a scale Standard Deviation 1.44	0.44 Units on a scale Standard Deviation 1.92	0.58 Units on a scale Standard Deviation 1.66
Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24 Week 12 (n=6,6,7,5,7,6,8,7)	-0.67 Units on a scale Standard Deviation 1.08	-0.25 Units on a scale Standard Deviation 0.76	0.21 Units on a scale Standard Deviation 0.86	0.60 Units on a scale Standard Deviation 0.89	-0.36 Units on a scale Standard Deviation 1.38	0.42 Units on a scale Standard Deviation 1.36	0.50 Units on a scale Standard Deviation 1.46	0.21 Units on a scale Standard Deviation 1.52

SECONDARY outcome

Timeframe: Screening to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.

Outcome measures

Measure	Placebo Every 2 Weeks n=5 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=5 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=6 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Whole brain - Week 12 (n=5,5,7,4,7,6,7,7)	-0.112 cm^3 Standard Deviation 0.738	-0.548 cm^3 Standard Deviation 1.001	-0.709 cm^3 Standard Deviation 1.026	-1.833 cm^3 Standard Deviation 2.001	0.533 cm^3 Standard Deviation 0.481	-0.528 cm^3 Standard Deviation 1.873	-0.177 cm^3 Standard Deviation 1.219	-1.109 cm^3 Standard Deviation 0.731
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)	-4.3 cm^3 Standard Deviation 2.7	-3.1 cm^3 Standard Deviation 3.1	-2.4 cm^3 Standard Deviation 1.7	-1.8 cm^3 Standard Deviation 4.2	-2.8 cm^3 Standard Deviation 2.6	-2.8 cm^3 Standard Deviation 3.9	-4.8 cm^3 Standard Deviation 5.0	-2.2 cm^3 Standard Deviation 3.7
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)	-3.8 cm^3 Standard Deviation 2.7	-2.6 cm^3 Standard Deviation 3.8	-3.6 cm^3 Standard Deviation 2.6	-3.0 cm^3 Standard Deviation 2.4	-4.8 cm^3 Standard Deviation 4.2	-1.8 cm^3 Standard Deviation 1.6	-1.5 cm^3 Standard Deviation 3.6	-4.9 cm^3 Standard Deviation 3.2
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)	-1.403 cm^3 Standard Deviation 0.978	-1.978 cm^3 Standard Deviation 0.798	-1.488 cm^3 Standard Deviation 0.726	-1.390 cm^3 Standard Deviation 1.678	-0.875 cm^3 Standard Deviation 0.780	-1.363 cm^3 Standard Deviation 1.752	-1.096 cm^3 Standard Deviation 1.004	-1.583 cm^3 Standard Deviation 1.070
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)	-7.6 cm^3 Standard Deviation 3.8	-6.6 cm^3 Standard Deviation 3.0	-6.0 cm^3 Standard Deviation 2.8	-5.2 cm^3 Standard Deviation 4.1	-6.0 cm^3 Standard Deviation 5.0	-7.4 cm^3 Standard Deviation 4.3	-6.9 cm^3 Standard Deviation 7.7	-6.2 cm^3 Standard Deviation 3.7
Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)	-7.3 cm^3 Standard Deviation 1.2	-4.4 cm^3 Standard Deviation 4.7	-6.3 cm^3 Standard Deviation 5.6	-4.5 cm^3 Standard Deviation 7.1	-5.1 cm^3 Standard Deviation 4.5	-5.3 cm^3 Standard Deviation 2.4	-6.5 cm^3 Standard Deviation 4.6	-8.2 cm^3 Standard Deviation 5.0

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.

Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.

Outcome measures

Measure	Placebo Every 2 Weeks n=7 Participants Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=6 Participants Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=6 Participants Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 Participants Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 Participants Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24 Right hippocampus - Baseline	0.83 µCi/mL Standard Deviation 0.06	0.81 µCi/mL Standard Deviation 0.06	0.81 µCi/mL Standard Deviation 0.06	0.83 µCi/mL Standard Deviation 0.06	0.81 µCi/mL Standard Deviation 0.08	0.88 µCi/mL Standard Deviation 0.03	0.82 µCi/mL Standard Deviation 0.08	0.81 µCi/mL Standard Deviation 0.04
Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24 Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)	0.84 µCi/mL Standard Deviation 0.07	0.83 µCi/mL Standard Deviation 0.07	0.83 µCi/mL Standard Deviation 0.06	0.81 µCi/mL Standard Deviation 0.02	0.82 µCi/mL Standard Deviation 0.07	0.87 µCi/mL Standard Deviation 0.04	0.84 µCi/mL Standard Deviation 0.07	0.82 µCi/mL Standard Deviation 0.03
Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24 Left hippocampus - Baseline	0.79 µCi/mL Standard Deviation 0.05	0.77 µCi/mL Standard Deviation 0.06	0.80 µCi/mL Standard Deviation 0.07	0.81 µCi/mL Standard Deviation 0.05	0.81 µCi/mL Standard Deviation 0.07	0.84 µCi/mL Standard Deviation 0.05	0.80 µCi/mL Standard Deviation 0.06	0.77 µCi/mL Standard Deviation 0.04
Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24 Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)	0.80 µCi/mL Standard Deviation 0.03	0.78 µCi/mL Standard Deviation 0.05	0.84 µCi/mL Standard Deviation 0.09	0.80 µCi/mL Standard Deviation 0.07	0.81 µCi/mL Standard Deviation 0.08	0.84 µCi/mL Standard Deviation 0.05	0.81 µCi/mL Standard Deviation 0.05	0.79 µCi/mL Standard Deviation 0.05

Adverse Events

Placebo Every 2 Weeks

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

0.1 g/kg Octagam 10% Every 2 Weeks

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

0.25 g/kg Octagam 10% Every 2 Weeks

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

0.4 g/kg Octagam 10% Every 2 Weeks

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Every 4 Weeks

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

0.2 g/kg Octagam 10% Every 4 Weeks

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

0.5 g/kg Octagam 10% Every 4 Weeks

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

0.8 g/kg Octagam 10% Every 4 Weeks

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Every 2 Weeks n=7 participants at risk Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 participants at risk Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 participants at risk Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=7 participants at risk Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 participants at risk Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=7 participants at risk Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 participants at risk Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 participants at risk Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Gastrointestinal disorders Gastral antral vascular ectasia	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Surgical and medical procedures Knee arthroplasty	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Surgical and medical procedures Spinal laminectomy	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Cerebral infarction	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Delirium	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Convulsion	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Dementia Alzheimer's Type	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Aggression	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.

Other adverse events

Measure	Placebo Every 2 Weeks n=7 participants at risk Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.1 g/kg Octagam 10% Every 2 Weeks n=6 participants at risk Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).	0.25 g/kg Octagam 10% Every 2 Weeks n=7 participants at risk Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	0.4 g/kg Octagam 10% Every 2 Weeks n=7 participants at risk Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).	Placebo Every 4 Weeks n=7 participants at risk Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.2 g/kg Octagam 10% Every 4 Weeks n=7 participants at risk Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).	0.5 g/kg Octagam 10% Every 4 Weeks n=8 participants at risk Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).	0.8 g/kg Octagam 10% Every 4 Weeks n=7 participants at risk Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Skin and subcutaneous tissue disorders Ecchymosis	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Vascular disorders Blood pressure fluctuation	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Vascular disorders Hypertension	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Vascular disorders Hypotension	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Vascular disorders Vasoconstriction	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Blood and lymphatic system disorders Anemia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Blood and lymphatic system disorders Iron deficiency anemia	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Ear and labyrinth disorders Hearing impaired	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Eye disorders Glaucoma	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Colitis microscopic	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Colonic polyp	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Hiatus hernia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Chills	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Fatigue	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Influenza like illness	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	28.6% 2/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Infusion site extravasation	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Pyrexia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
General disorders Submandibular mass	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Bronchitis	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Gastroenteritis	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Tooth abscess	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Tooth infection	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Infections and infestations Urinary tract infection	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Anxiety postoperative	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Procedural headache	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood iron decreased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood magnesium decreased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood potassium decreased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Blood pressure decreased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations CSF white blood cell count positive	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Investigations Weight decreased	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Cerebral haemorrhage	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	33.3% 2/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Dizziness	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Essential tremor	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Headache	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Hypertonia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Hypoaesthesia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	12.5% 1/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Hyporeflexia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Paraesthesia	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Nervous system disorders Tremor	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Agitation	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Confusional state	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Depression	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Psychiatric disorders Insomnia	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	16.7% 1/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Renal and urinary disorders Haematuria	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/6 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	14.3% 1/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/8 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.	0.00% 0/7 • Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit. Safety set: All randomized participants who received at least 1 infusion of study medication.

Additional Information

Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine

Octapharma USA

Phone: 201-604-1155

Email: michael.eppolito@octapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place