Trial Outcomes & Findings for Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease (NCT NCT01193608)

NCT ID: NCT01193608

Last Updated: 2017-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 88 participants
• Primary outcome timeframe: Baseline up to 39 Weeks and at Early Withdrawal
• Results posted on: 2017-02-23

Participant Flow

Participant milestones

Measure	AAB-003 0.5 mg/kg Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 1 mg/kg Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	Placebo Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
Overall Study STARTED	6	6	16	17	24	19
Overall Study COMPLETED	6	4	14	14	19	17
Overall Study NOT COMPLETED	0	2	2	3	5	2

Reasons for withdrawal

Measure	AAB-003 0.5 mg/kg Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 1 mg/kg Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.	Placebo Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
Overall Study Other	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	1	2	3	3	0
Overall Study Lost to Follow-up	0	0	0	0	1	2
Overall Study Adverse Event	0	0	0	0	1	0

Baseline Characteristics

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

Baseline characteristics by cohort

Measure	AAB-003 0.5 mg/kg n=6 Participants Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 1 mg/kg n=6 Participants Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	Total n=88 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants	67.2 Years STANDARD_DEVIATION 7.4 • n=7 Participants	70.7 Years STANDARD_DEVIATION 10.8 • n=5 Participants	71.5 Years STANDARD_DEVIATION 8.8 • n=4 Participants	64.5 Years STANDARD_DEVIATION 7.6 • n=21 Participants	71.1 Years STANDARD_DEVIATION 7.6 • n=10 Participants	68.6 Years STANDARD_DEVIATION 8.8 • n=115 Participants
Gender Female	4 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	14 Participants n=21 Participants	8 Participants n=10 Participants	52 Participants n=115 Participants
Gender Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	11 Participants n=10 Participants	36 Participants n=115 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants	11 Participants n=10 Participants	41 Participants n=115 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	5 Participants n=10 Participants	38 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline up to 39 Weeks and at Early Withdrawal

Population: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with Adverse Events (AEs)	5 Participants	3 Participants	10 Participants	8 Participants	16 Participants	12 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with Serious Adverse Events (SAEs)	1 Participants	1 Participants	1 Participants	0 Participants	5 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants Discontinued due to AEs	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to 39 Weeks and at Early Withdrawal

Population: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Laboratory Abnormalities	3 Participants	3 Participants	11 Participants	10 Participants	12 Participants	13 Participants

PRIMARY outcome

Timeframe: Baseline up to 39 Weeks and at Early Withdrawal

Population: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions).

Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Vital Signs of Potential Clinical Concern Supine SBP <90 mm Hg	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Maximum increase in supine SBP >=30 mm Hg	3 Participants	0 Participants	3 Participants	7 Participants	2 Participants	6 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Maximum decrease in supine SBP >=30 mm Hg	0 Participants	0 Participants	5 Participants	0 Participants	4 Participants	8 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Sitting SBP <90 mm Hg	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Supine DBP <50 mm Hg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Maximum increase in supine DBP >=20 mm Hg	2 Participants	3 Participants	4 Participants	2 Participants	5 Participants	8 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Maximum decrease in supine DBP >=20 mm Hg	1 Participants	0 Participants	4 Participants	1 Participants	4 Participants	8 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Sitting DBP <50 mm Hg	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Supine pulse rate <40 or >120 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Concern Sitting pulse rate <40 or >120 bpm	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	NA Participants Data not collected	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 39 Weeks and at Early Withdrawal

Population: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Abnormal Physical Examination Findings	2 Participants	4 Participants	1 Participants	5 Participants	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal

Population: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). n = number of evaluable participants at the corresponding time point.

The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Abnormal Neurological Examination Findings Day 1 (n=6,6,16,17,24,19)	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	6 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 1 (n=6,6,16,17,24,19)	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 6 (n=6,6,16,17,24,19)	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 13 (n=6,6,15,16,22,19)	1 Participants	1 Participants	4 Participants	3 Participants	0 Participants	4 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 19 (n=6,5,14,15,21,19)	1 Participants	1 Participants	1 Participants	4 Participants	1 Participants	4 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 26 (n=6,5,14,14,18,19)	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants	7 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 32 (n=6,5,14,14,19,18)	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	6 Participants
Number of Participants With Abnormal Neurological Examination Findings Week 39 (n=6,4,14,14,19,17)	1 Participants	1 Participants	1 Participants	4 Participants	0 Participants	6 Participants

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Pharmacokinetic (PK) Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1	13.79 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 48	32.05 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 33	58.74 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 21	122.4 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 14	223.7 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 28	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=17 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26	14.53 mcg/mL Geometric Coefficient of Variation 33	38.51 mcg/mL Geometric Coefficient of Variation 25	60.17 mcg/mL Geometric Coefficient of Variation 38	108.5 mcg/mL Geometric Coefficient of Variation 41	228.9 mcg/mL Geometric Coefficient of Variation 30	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=15 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=16 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=22 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Average Concentration (Cavg) for AAB-003 in Serum at Day 1	2.465 mcg/mL Geometric Coefficient of Variation 30	6.545 mcg/mL Geometric Coefficient of Variation 33	10.83 mcg/mL Geometric Coefficient of Variation 16	20.37 mcg/mL Geometric Coefficient of Variation 20	36.78 mcg/mL Geometric Coefficient of Variation 24	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=4 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=17 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Average Concentration (Cavg) for AAB-003 in Serum at Week 26	3.435 mcg/mL Geometric Coefficient of Variation 22	7.171 mcg/mL Geometric Coefficient of Variation 9	12.56 mcg/mL Geometric Coefficient of Variation 28	22.52 mcg/mL Geometric Coefficient of Variation 29	46.12 mcg/mL Geometric Coefficient of Variation 34	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1	1.92 Hours (hr) Full Range 30 • Interval 1.5 to 6.05	4.00 Hours (hr) Full Range 33 • Interval 2.17 to 6.02	1.54 Hours (hr) Full Range 16 • Interval 1.2 to 2.12	1.50 Hours (hr) Full Range 20 • Interval 1.0 to 24.0	3.02 Hours (hr) Full Range 24 • Interval 1.07 to 6.0	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=17 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26	1.56 Hours (hr) Full Range 22 • Interval 1.3 to 4.05	2.00 Hours (hr) Full Range 9 • Interval 1.25 to 5.95	1.64 Hours (hr) Full Range 28 • Interval 1.05 to 6.03	2.00 Hours (hr) Full Range 29 • Interval 1.03 to 6.03	1.50 Hours (hr) Full Range 34 • Interval 1.07 to 23.9	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1	5397 mcg*hr/mL Geometric Coefficient of Variation 30	13470 mcg*hr/mL Geometric Coefficient of Variation 33	22960 mcg*hr/mL Geometric Coefficient of Variation 19	44000 mcg*hr/mL Geometric Coefficient of Variation 20	79130 mcg*hr/mL Geometric Coefficient of Variation 23	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=4 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=3 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=19 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1	5597 mcg*hr/mL Geometric Coefficient of Variation 39	13060 mcg*hr/mL Geometric Coefficient of Variation 18	25270 mcg*hr/mL Geometric Coefficient of Variation 17	46430 mcg*hr/mL Geometric Coefficient of Variation 21	82140 mcg*hr/mL Geometric Coefficient of Variation 23	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=15 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=16 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=22 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1	5384 mcg*hr/mL Geometric Coefficient of Variation 30 • Interval 1.5 to 6.05	14300 mcg*hr/mL Geometric Coefficient of Variation 33 • Interval 2.17 to 6.02	23660 mcg*hr/mL Geometric Coefficient of Variation 16 • Interval 1.2 to 2.12	44490 mcg*hr/mL Geometric Coefficient of Variation 20 • Interval 1.0 to 24.0	80320 mcg*hr/mL Geometric Coefficient of Variation 24 • Interval 1.07 to 6.0	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=4 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=17 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26	7502 mcg*hr/mL Geometric Coefficient of Variation 22 • Interval 1.3 to 4.05	15660 mcg*hr/mL Geometric Coefficient of Variation 9 • Interval 1.25 to 5.95	27440 mcg*hr/mL Geometric Coefficient of Variation 28 • Interval 1.05 to 6.03	49180 mcg*hr/mL Geometric Coefficient of Variation 29 • Interval 1.03 to 6.03	100700 mcg*hr/mL Geometric Coefficient of Variation 34 • Interval 1.07 to 23.9	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=4 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=3 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=19 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Systemic Clearance (CL) for AAB-003 in Serum at Day 1	0.08934 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 39	0.07657 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 18	0.07914 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 17	0.08615 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 21	0.09739 milliliter/hour/kilogram (mL/hr/kg) Geometric Coefficient of Variation 23	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=4 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=17 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Systemic Clearance (CL) for AAB-003 in Serum at Week 26	0.06665 mL/hr/kg Geometric Coefficient of Variation 22	0.06385 mL/hr/kg Geometric Coefficient of Variation 9	0.07289 mL/hr/kg Geometric Coefficient of Variation 28	0.08133 mL/hr/kg Geometric Coefficient of Variation 29	0.07943 mL/hr/kg Geometric Coefficient of Variation 34	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=4 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=3 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=19 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1	78.44 mL/kg Geometric Coefficient of Variation 38	59.74 mL/kg Geometric Coefficient of Variation 37	61.67 mL/kg Geometric Coefficient of Variation 21	60.44 mL/kg Geometric Coefficient of Variation 26	75.12 mL/kg Geometric Coefficient of Variation 27	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=5 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=4 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=13 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=11 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=16 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26	54.66 mL/kg Geometric Coefficient of Variation 18	48.27 mL/kg Geometric Coefficient of Variation 9	56.90 mL/kg Geometric Coefficient of Variation 37	65.11 mL/kg Geometric Coefficient of Variation 23	61.24 mL/kg Geometric Coefficient of Variation 46	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=4 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=3 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=14 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=19 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Serum Decay Half-Life (t1/2) for AAB-003 at Day 1	27.77 Days Standard Deviation 6.9880	20.04 Days Standard Deviation 8.9210	24.45 Days Standard Deviation 4.8686	21.10 Days Standard Deviation 5.2000	22.89 Days Standard Deviation 4.5086	—

PRIMARY outcome

Timeframe: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

Population: Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).

Outcome measures

Measure	AAB-003 8 mg/kg n=5 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=4 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=13 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=11 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=16 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Serum Decay Half-Life (t1/2) for AAB-003 at Week 26	23.41 Days Standard Deviation 6.8638	22.32 Days Standard Deviation 3.1454	22.83 Days Standard Deviation 4.1356	22.27 Days Standard Deviation 3.2448	22.81 Days Standard Deviation 4.3455	—

PRIMARY outcome

Timeframe: Baseline up to Week 39 or Early Withdrawal

Population: Safety Analysis Set included all participants who received at least one infusion of study medication (including partial infusions).

The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 32.

Population: Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).

Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1, Week 13, and Week 26

Population: Safety Analysis Set included all participants who received an infusion of study medication, including partial infusions. n = number of evaluable participants at the corresponding timeframe.

VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit Day 1 (n=6,6,16,17,24,19)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit Week 13 (n=6,5,15,16,21,17)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit Week 26 (n=6,5,14,14,17,16)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1,13,16,26,39 or Early Withdrawal

Population: Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).

Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum PR Interval >=300 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QRS Complex >=200 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QTcF Interval 450 to <480 msec	0 Participants	2 Participants	5 Participants	4 Participants	4 Participants	3 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QTcF Interval 480 to <500 msec	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QTcF Interval >=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria PR Interval >=25/50% increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria QRS Complex >=25/50% increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QTcF Increase from Baseline 30 to <60 msec	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria Maximum QTcF Interval Increase >=60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal

Population: All participants who received an infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum Day 1 (n=6,6,16,17,24,19)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum Week 13 (n=6,5,15,16,22,19)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum Week 26 (n=6,5,14,14,17,18)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum Week 39 (n=6,4,14,14,19,16)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 13, 26 and 39

Population: All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39 Baseline (n=6,6,16,17,24,19)	12.6 Units on a scale Standard Deviation 3.73	20.4 Units on a scale Standard Deviation 7.49	21.6 Units on a scale Standard Deviation 10.76	23.0 Units on a scale Standard Deviation 11.15	18.0 Units on a scale Standard Deviation 7.28	18.4 Units on a scale Standard Deviation 7.54
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39 Week 13 (n=6,5,15,15,22,19)	1.3 Units on a scale Standard Deviation 1.45	3.3 Units on a scale Standard Deviation 4.39	-0.4 Units on a scale Standard Deviation 5.08	3.2 Units on a scale Standard Deviation 4.18	-1.2 Units on a scale Standard Deviation 4.20	0.2 Units on a scale Standard Deviation 3.40
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39 Week 26 (n=6,5,14,13,18,19)	0.9 Units on a scale Standard Deviation 2.73	0.7 Units on a scale Standard Deviation 4.73	0.5 Units on a scale Standard Deviation 5.40	3.3 Units on a scale Standard Deviation 5.55	-0.8 Units on a scale Standard Deviation 5.07	1.4 Units on a scale Standard Deviation 5.85
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39 Week 39 (n=6,4,14,13,19,17)	0.2 Units on a scale Standard Deviation 3.13	1.4 Units on a scale Standard Deviation 3.41	2.6 Units on a scale Standard Deviation 6.80	4.1 Units on a scale Standard Deviation 9.80	-0.5 Units on a scale Standard Deviation 5.88	1.4 Units on a scale Standard Deviation 3.95

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 13, 26 and 39

Population: All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39 Week 26 (n=6,5,14,14,18,19)	4.3 Units on a scale Standard Deviation 9.20	-0.8 Units on a scale Standard Deviation 12.30	-3.8 Units on a scale Standard Deviation 10.20	-10.4 Units on a scale Standard Deviation 14.93	0.2 Units on a scale Standard Deviation 14.32	-2.5 Units on a scale Standard Deviation 7.73
Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39 Baseline (n=6,6,16,17,24,19)	84.5 Units on a scale Standard Deviation 11.27	63.7 Units on a scale Standard Deviation 31.89	78.6 Units on a scale Standard Deviation 20.84	77.9 Units on a scale Standard Deviation 17.91	84.8 Units on a scale Standard Deviation 15.31	84.9 Units on a scale Standard Deviation 12.65
Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39 Week 13 (n=6,6,15,16,22,19)	5.7 Units on a scale Standard Deviation 8.82	-1.2 Units on a scale Standard Deviation 14.22	-3.8 Units on a scale Standard Deviation 11.61	-5.1 Units on a scale Standard Deviation 15.57	-6.3 Units on a scale Standard Deviation 12.71	-3.0 Units on a scale Standard Deviation 7.56
Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39 Week 39 (n=6,4,14,14,19,17)	-1.8 Units on a scale Standard Deviation 8.40	0.5 Units on a scale Standard Deviation 12.92	-6.9 Units on a scale Standard Deviation 11.33	-14.6 Units on a scale Standard Deviation 19.52	-1.9 Units on a scale Standard Deviation 12.39	-1.8 Units on a scale Standard Deviation 11.31

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 13, 26 and 39

Population: All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI - delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology).

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39 Baseline (n=6,6,16,17,23,19)	11.7 Units on a scale Standard Deviation 9.67	6.3 Units on a scale Standard Deviation 9.18	9.1 Units on a scale Standard Deviation 8.69	10.8 Units on a scale Standard Deviation 11.46	7.7 Units on a scale Standard Deviation 7.30	13.8 Units on a scale Standard Deviation 12.93
Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39 Week 13 (n=6,6,15,15,21,18)	-2.7 Units on a scale Standard Deviation 4.80	4.8 Units on a scale Standard Deviation 6.68	-0.7 Units on a scale Standard Deviation 4.27	0.4 Units on a scale Standard Deviation 7.31	0.3 Units on a scale Standard Deviation 4.94	-2.1 Units on a scale Standard Deviation 6.81
Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39 Week 26 (n=6,5,14,14,18,19)	-1.7 Units on a scale Standard Deviation 5.24	4.8 Units on a scale Standard Deviation 4.09	-1.2 Units on a scale Standard Deviation 2.94	4.6 Units on a scale Standard Deviation 12.17	0.3 Units on a scale Standard Deviation 6.01	-3.4 Units on a scale Standard Deviation 8.65
Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39 Week 39 (n=6,3,14,13,19,17)	0.5 Units on a scale Standard Deviation 5.21	3.3 Units on a scale Standard Deviation 2.52	0.6 Units on a scale Standard Deviation 6.61	4.8 Units on a scale Standard Deviation 17.07	0.1 Units on a scale Standard Deviation 6.70	-2.6 Units on a scale Standard Deviation 10.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 26 and 39

Population: All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories - memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 CDS-SB - Baseline (n=6,6,16,17,24,19)	8.00 Units on a scale Standard Deviation 1.673	11.17 Units on a scale Standard Deviation 4.070	9.50 Units on a scale Standard Deviation 4.351	10.94 Units on a scale Standard Deviation 3.614	8.75 Units on a scale Standard Deviation 3.566	8.89 Units on a scale Standard Deviation 3.381
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 Global CDR - Baseline (n=6,6,16,17,24,19)	0.67 Units on a scale Standard Deviation 0.258	1.08 Units on a scale Standard Deviation 0.492	1.03 Units on a scale Standard Deviation 0.618	1.09 Units on a scale Standard Deviation 0.476	0.85 Units on a scale Standard Deviation 0.429	0.87 Units on a scale Standard Deviation 0.467
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 CDR-SB - Week 26 (n=6,5,14,14,18,19)	1.33 Units on a scale Standard Deviation 1.751	1.40 Units on a scale Standard Deviation 1.517	-0.07 Units on a scale Standard Deviation 2.056	1.29 Units on a scale Standard Deviation 2.758	0.17 Units on a scale Standard Deviation 1.855	0.16 Units on a scale Standard Deviation 1.979
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 Global CDR - Week 26 (n=6,5,14,14,18,19)	0.33 Units on a scale Standard Deviation 0.408	0.30 Units on a scale Standard Deviation 0.447	0.04 Units on a scale Standard Deviation 0.414	0.25 Units on a scale Standard Deviation 0.510	0.03 Units on a scale Standard Deviation 0.320	-0.03 Units on a scale Standard Deviation 0.262
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 CDR-SB - Week 39 (n=6,4,14,14,19,17)	1.00 Units on a scale Standard Deviation 3.286	1.75 Units on a scale Standard Deviation 1.708	1.00 Units on a scale Standard Deviation 2.449	1.86 Units on a scale Standard Deviation 3.371	0.79 Units on a scale Standard Deviation 2.840	-0.35 Units on a scale Standard Deviation 1.935
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 Global CDR - Week 39 (n=6,4,14,14,19,17)	0.33 Units on a scale Standard Deviation 0.408	0.13 Units on a scale Standard Deviation 0.250	0.04 Units on a scale Standard Deviation 0.414	0.50 Units on a scale Standard Deviation 0.679	0.13 Units on a scale Standard Deviation 0.436	-0.06 Units on a scale Standard Deviation 0.300

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 13, 26 and 39

Population: All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.

The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39 Week 39 (n=6,4,14,14,19,17)	1.5 Units on a scale Standard Deviation 4.18	-1.0 Units on a scale Standard Deviation 0.82	-0.2 Units on a scale Standard Deviation 2.58	-2.2 Units on a scale Standard Deviation 4.56	1.4 Units on a scale Standard Deviation 3.55	0.5 Units on a scale Standard Deviation 3.06
Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39 Week 13 (n=6,6,15,16,22,19)	1.8 Units on a scale Standard Deviation 2.32	-0.5 Units on a scale Standard Deviation 2.35	0.1 Units on a scale Standard Deviation 2.45	-1.4 Units on a scale Standard Deviation 2.78	0.9 Units on a scale Standard Deviation 2.00	1.0 Units on a scale Standard Deviation 1.60
Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39 Week 26 (n=6,5,14,14,18,19)	1.8 Units on a scale Standard Deviation 1.72	0.2 Units on a scale Standard Deviation 1.10	0.0 Units on a scale Standard Deviation 3.51	-2.0 Units on a scale Standard Deviation 2.96	1.6 Units on a scale Standard Deviation 2.91	0.7 Units on a scale Standard Deviation 2.91
Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39 Baseline (n=6,6,16,17,24,19)	22.7 Units on a scale Standard Deviation 1.37	22.5 Units on a scale Standard Deviation 2.43	20.8 Units on a scale Standard Deviation 3.71	20.1 Units on a scale Standard Deviation 3.00	21.2 Units on a scale Standard Deviation 2.82	21.2 Units on a scale Standard Deviation 3.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 32 or Early Withdrawal

Population: All randomized and treated participants in the 2, 4 and 8 mg/kg cohorts who consented to the collection of CSF samples.

Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=15 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32	15.220 nanogram/millliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable	45.020 nanogram/millliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable	79.160 nanogram/millliter (ng/mL) Standard Deviation 53.0486	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=15 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups	113.53 picogram/milliliter (pg/mL) Standard Deviation 817.270	348.64 picogram/milliliter (pg/mL) Standard Deviation 1321.047	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Baseline	5685.4 picogram/milliliter (pg/mL) Standard Deviation NA There were insufficient numbers of participants for group analysis.	7413.6 picogram/milliliter (pg/mL) Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—
CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Week 32	5836.1 picogram/milliliter (pg/mL) Standard Deviation NA There were insufficient numbers of participants for group analysis.	8883.2 picogram/milliliter (pg/mL) Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=15 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups	48.85 pg/mL Standard Deviation 174.589	24.04 pg/mL Standard Deviation 173.610	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Baseline	485.6 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	217.2 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—
CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Week 32	343.3 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	331 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=15 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups	-15.26 pg/mL Standard Deviation 110.229	67.94 pg/mL Standard Deviation 63.514	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Baseline	659.6 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	856.1 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—
CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Week 32	739.4 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	1115.6 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=15 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups	1.23 pg/mL Standard Deviation 8.986	1.92 pg/mL Standard Deviation 7.755	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 32

Population: The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Baseline	89 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	122.7 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—
CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups Week 32	100.3 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	140.5 pg/mL Standard Deviation NA There were insufficient numbers of participants for group analysis.	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication and have at least one postdose pharmacodynamic (PD) parameter assessment. n = number of evaluable participants at the corresponding timeframe.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=6 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40 Week 1 - Week 13 (n=6,5,14,16,22,19)	3.321 ng/mL Geometric Coefficient of Variation 50	6.959 ng/mL Geometric Coefficient of Variation 29	8.202 ng/mL Geometric Coefficient of Variation 19	11.89 ng/mL Geometric Coefficient of Variation 10	18.03 ng/mL Geometric Coefficient of Variation 19	0.3511 ng/mL Geometric Coefficient of Variation 25
Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40 Week 26 - Week 39 (n=5,4,14,14,17,14)	1.964 ng/mL Geometric Coefficient of Variation 35	3.805 ng/mL Geometric Coefficient of Variation 31	3.804 ng/mL Geometric Coefficient of Variation 23	7.537 ng/mL Geometric Coefficient of Variation 26	12.25 ng/mL Geometric Coefficient of Variation 20	0.4689 ng/mL Geometric Coefficient of Variation 84

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=15 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=16 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=22 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40 Week 1 - Week 13 (n=6,5,14,16,22,19)	24.2 Hours Full Range 50 • Interval 22.3 to 149.0	24.0 Hours Full Range 29 • Interval 24.0 to 169.0	24.0 Hours Full Range 19 • Interval 24.0 to 170.0	166 Hours Full Range 10 • Interval 24.0 to 238.0	164 Hours Full Range 19 • Interval 92.2 to 1050.0	168 Hours Full Range 25 • Interval 0.0 to 2540.0
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40 Week 26 - Week 39 (n=5,4,14,14,17,14)	2.03 Hours Full Range 35 • Interval 2.02 to 596.0	2.00 Hours Full Range 31 • Interval 2.0 to 2.02	983 Hours Full Range 23 • Interval 2.0 to 1080.0	1010 Hours Full Range 26 • Interval 958.0 to 1060.0	1010 Hours Full Range 20 • Interval 1.98 to 1080.0	1030 Hours Full Range 84 • Interval 0.0 to 2210.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUClast.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=14 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=16 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=22 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40	2664 ng*hr/mL Geometric Coefficient of Variation 31 • Interval 22.3 to 149.0	6041 ng*hr/mL Geometric Coefficient of Variation 47 • Interval 24.0 to 169.0	7836 ng*hr/mL Geometric Coefficient of Variation 19 • Interval 24.0 to 170.0	12970 ng*hr/mL Geometric Coefficient of Variation 17 • Interval 24.0 to 238.0	22910 ng*hr/mL Geometric Coefficient of Variation 25 • Interval 92.2 to 1050.0	639.7 ng*hr/mL Geometric Coefficient of Variation 23 • Interval 0.0 to 2540.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUCinf. No participants had available data for AUCinf in AAB-003 8 mg/kg and Placebo Groups.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=9 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=2 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40	2916 ng*hr/mL Geometric Coefficient of Variation NA Standard deviation was not estimable since only one participant was evaluable	5463 ng*hr/mL Geometric Coefficient of Variation NA Standard deviation was not estimable since only one participant was evaluable	8965 ng*hr/mL Geometric Coefficient of Variation 19	12800 ng*hr/mL Geometric Coefficient of Variation 1	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.

Outcome measures

Measure	AAB-003 8 mg/kg n=6 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=5 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=15 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=16 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=22 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40 Week 1 - Week 13 (n=6,5,14,16,22,19)	2647 ng*hr/mL Geometric Coefficient of Variation 31 • Interval 22.3 to 149.0	6057 ng*hr/mL Geometric Coefficient of Variation 47 • Interval 24.0 to 169.0	7854 ng*hr/mL Geometric Coefficient of Variation 19 • Interval 24.0 to 170.0	12940 ng*hr/mL Geometric Coefficient of Variation 17 • Interval 24.0 to 238.0	22820 ng*hr/mL Geometric Coefficient of Variation 26 • Interval 92.2 to 1050.0	631.6 ng*hr/mL Geometric Coefficient of Variation 23 • Interval 0.0 to 2540.0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40 Week 26 - Week 39 (n=5,4,14,14,17,14)	2614 ng*hr/mL Geometric Coefficient of Variation 32 • Interval 2.02 to 596.0	4929 ng*hr/mL Geometric Coefficient of Variation 37 • Interval 2.0 to 2.02	6119 ng*hr/mL Geometric Coefficient of Variation 31 • Interval 2.0 to 1080.0	11910 ng*hr/mL Geometric Coefficient of Variation 26 • Interval 958.0 to 1060.0	19740 ng*hr/mL Geometric Coefficient of Variation 25 • Interval 1.98 to 1080.0	798.8 ng*hr/mL Geometric Coefficient of Variation 55 • Interval 0.0 to 2210.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

Population: All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for t1/2. No participants had available data for t1/2 in AAB-003 8 mg/kg and Placebo Groups.

Outcome measures

Measure	AAB-003 8 mg/kg n=1 Participants Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=1 Participants Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=9 Participants Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=2 Participants Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40	26.57 Day Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable	32.14 Day Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable	30.71 Day Standard Deviation 3.2303	29.41 Day Standard Deviation 5.7374	—	—

Adverse Events

AAB-003 0.5 mg/kg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

AAB-003 1 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

AAB-003 2 mg/kg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

AAB-003 4 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

AAB-003 8 mg/kg

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	AAB-003 0.5 mg/kg n=6 participants at risk Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 1 mg/kg n=6 participants at risk Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 participants at risk Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 participants at risk Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 participants at risk Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 participants at risk Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
General disorders Chest Pain	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral Microhaemorrhage	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Vasogenic Cerebral Oedema	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	AAB-003 0.5 mg/kg n=6 participants at risk Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 1 mg/kg n=6 participants at risk Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 2 mg/kg n=16 participants at risk Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 4 mg/kg n=17 participants at risk Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26	AAB-003 8 mg/kg n=24 participants at risk Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26	Placebo n=19 participants at risk Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
Gastrointestinal disorders Abdominal Pain Lower	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Palpitations	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear Disorder	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Tooth Impacted	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Infusion Site Bruising	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary Tract Infection	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.8% 2/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth Infection	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Lymph Node Palpable	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Otoscopy Abnormal	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.8% 3/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.8% 2/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sinus Headache	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary Incontinence	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot Flush	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Gait Disturbance	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.8% 2/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Infusion Site Erythema	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Infusion Site Haemorrhage	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Infusion Site Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Infusion Site Swelling	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	12.5% 2/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	12.5% 2/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine Aminotransferase Increased	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate Aminotransferase Increased	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood Bilirubin Abnormal	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Bradykinesia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	12.5% 2/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.8% 2/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.5% 2/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	12.5% 2/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.5% 2/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depressed Mood	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep Disorder	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 1/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival Hyperaemia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Deafness Unilateral	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Injection Site Swelling	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Irritability	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Swelling	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Overdose	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight Decreased	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypotonia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Lacunar Infarction	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomina	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.9% 1/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood Creatinine Increased	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 1/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight Increased	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 2/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chills	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Diverticulitis	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Excoriation	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post Lumbar Puncture Syndrome	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Laceration	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesenteric Neoplasm	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Coordination Abnormal	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Memory Impairment	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hypersexuality	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Calculus Ureteric	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal Cyst	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Aortic Calcification	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Flushing	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/17 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/24 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 1/19 • Baseline up to 39 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER