Trial Outcomes & Findings for An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum (NCT NCT02406027)

Last Updated: 2025-04-29

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between administration of study drug and up to 3 years that were absent before treatment or that worsened relative to pre-treatment state. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2025-04-29

Participant Flow

Participants who completed their treatment period as described under the parent protocol in study 54861911ALZ2002 (NCT02260674) or any ongoing/future Phase 1b or Phase 2 atabecestat clinical study were enrolled in this study.

Participant milestones

Participant milestones
Measure	Double-blind Treatment Phase (Period 1): Placebo Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 25 mg Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1) STARTED	35	29	26	0	0	0	0
Double-blind Treatment Phase (Period 1) Asymptomatic at Risk	6	8	6	0	0	0	0
Double-blind Treatment Phase (Period 1) Prodromal	29	21	20	0	0	0	0
Double-blind Treatment Phase (Period 1) COMPLETED	29	26	22	0	0	0	0
Double-blind Treatment Phase (Period 1) NOT COMPLETED	6	3	4	0	0	0	0
Open-label Phase (Period 2) STARTED	0	0	0	15	14	26	22
Open-label Phase (Period 2) COMPLETED	0	0	0	0	0	0	0
Open-label Phase (Period 2) NOT COMPLETED	0	0	0	15	14	26	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-blind Treatment Phase (Period 1): Placebo Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 25 mg Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1) Adverse Event	0	2	1	0	0	0	0
Double-blind Treatment Phase (Period 1) Physician Decision	3	0	1	0	0	0	0
Double-blind Treatment Phase (Period 1) Withdrawal by Subject	2	1	1	0	0	0	0
Double-blind Treatment Phase (Period 1) Subject Refused Further Study Treatment	1	0	1	0	0	0	0
Open-label Phase (Period 2) Adverse Event	0	0	0	2	2	0	0
Open-label Phase (Period 2) Physician Decision	0	0	0	0	0	1	1
Open-label Phase (Period 2) Withdrawal by Subject	0	0	0	2	4	0	2
Open-label Phase (Period 2) Study Terminated by Sponsor	0	0	0	11	7	24	19
Open-label Phase (Period 2) At Spouse Request With PI Agreement	0	0	0	0	0	1	0
Open-label Phase (Period 2) Subject not Compliant to Study Procedure	0	0	0	0	1	0	0

Baseline Characteristics

An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Total n=90 Participants Total of all reporting groups
Age, Continuous	70.4 years STANDARD_DEVIATION 5.15 • n=5 Participants	71.4 years STANDARD_DEVIATION 7.04 • n=7 Participants	67.9 years STANDARD_DEVIATION 8.87 • n=5 Participants	70 years STANDARD_DEVIATION 7.06 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	47 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	83 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants	89 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized White Non-Hispanic	33 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	83 Participants n=4 Participants
Region of Enrollment BELGIUM	6 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment FRANCE	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment GERMANY	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment NETHERLANDS	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment SPAIN	10 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment SWEDEN	7 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).

Outcome measures

Outcome measures
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg n=15 Participants Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg n=14 Participants Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg n=26 Participants Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg n=22 Participants Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Number of Participants with TEAEs	22 Participants	15 Participants	21 Participants	10 Participants	11 Participants	19 Participants	16 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Number of Participants with Serious TEAEs	3 Participants	4 Participants	4 Participants	2 Participants	4 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Double-blind (DB) Day 1 and DB Week 52

Population: The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.

CSF samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, and ABeta 1-42. ABeta fragments of different length produced by cleavage of amyloid precursor protein (APP) by beta-secretase (BACE) and gamma-secretase complex in brain and excreted into CSF. Participants were classified as asymptomatic at risk: cognitively and functionally normal (Clinical Dementia Rating Scale score \[CDR\] =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).

Outcome measures

Outcome measures
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-37: Asymptomatic at Risk: DB Week 52	-9.9 Percent change Standard Deviation 7.32	-65.4 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	-90.0 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-37: Prodromal: DB Day 1	6.1 Percent change Standard Deviation 10.09	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-37: Prodromal: DB Week 52	-8.8 Percent change Standard Deviation 17.75	-62.0 Percent change Standard Deviation 11.02	-65.9 Percent change Standard Deviation 23.16	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-38: Asymptomatic at Risk: DB Week 52	-9.3 Percent change Standard Deviation 7.02	-42.9 Percent change Standard Deviation 17.49	-83.5 Percent change Standard Deviation 4.84	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-38: Prodromal: DB Day 1	10.2 Percent change Standard Deviation 15.41	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-38: Prodromal: DB Week 52	-9.7 Percent change Standard Deviation 16.52	-58.6 Percent change Standard Deviation 10.21	-70.4 Percent change Standard Deviation 23.53	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-40: Asymptomatic at Risk: DB Week 52	-9.7 Percent change Standard Deviation 6.12	-46.2 Percent change Standard Deviation 18.22	-84.6 Percent change Standard Deviation 5.43	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-40: Prodromal: DB Day 1	8.6 Percent change Standard Deviation 17.19	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-40: Prodromal: DB Week 52	-14.5 Percent change Standard Deviation 20.48	-60.7 Percent change Standard Deviation 13.52	-72.8 Percent change Standard Deviation 22.30	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-42: Asymptomatic at Risk: DB Week 52	-10.1 Percent change Standard Deviation 7.81	-39.6 Percent change Standard Deviation 24.28	-76.7 Percent change Standard Deviation 11.01	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-42: Prodromal: DB Day 1	8.0 Percent change Standard Deviation 7.44	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels CSF ABeta 1-42: Prodromal: DB Week 52	-15.0 Percent change Standard Deviation 20.51	-52.5 Percent change Standard Deviation 11.60	-57.6 Percent change Standard Deviation 31.42	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, DB Day 1 and DB Week 52

The CSF samples were obtained for measuring levels of different soluble amyloid precursor protein (sAPP) fragments (sAPP-alpha, sAPP-beta). Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage alzheimer's disease (AD) (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).

Outcome measures

Outcome measures
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-alpha: Asymptomatic at Risk: DB Week 52	-4.7 Percent change Standard Deviation 12.78	50.1 Percent change Standard Deviation 13.67	77.8 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-alpha: Prodromal: DB Day 1	0.9 Percent change Standard Deviation 24.97	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-alpha: Prodromal: DB Week 52	-11.2 Percent change Standard Deviation 14.01	60.2 Percent change Standard Deviation 24.03	85.1 Percent change Standard Deviation 39.35	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-Beta: Asymptomatic at Risk: DB Week 52	-10.8 Percent change Standard Deviation 8.44	-57.5 Percent change Standard Deviation 8.06	-90.8 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-Beta: Prodromal: DB Day 1	0.4 Percent change Standard Deviation 18.93	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels CSF sAPP-Beta: Prodromal: DB Week 52	-11.7 Percent change Standard Deviation 14.47	-63.5 Percent change Standard Deviation 5.19	-73.0 Percent change Standard Deviation 21.79	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, DB Day 1, DB Week 24, and DB Week 52

Plasma samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length were produced by cleavage of APP by beta-secretase (BACE) and gamma-secretase complex in different peripheral tissues, including white blood cells and were measured in plasma. Participants classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).

Outcome measures

Outcome measures
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-38:Asymptomatic at Risk: DB Week 24	-9.9 Percent change Standard Deviation 0.83	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-38: Asymptomatic at Risk:DB Week 52	-5.3 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-38: Prodromal: DB Day 1	-5.0 Percent change Standard Deviation 10.07	—	-6.6 Percent change Standard Deviation 13.56	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-38: Prodromal: DB Week 24	3.0 Percent change Standard Deviation 24.32	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-38: Prodromal: DB Week 52	20.3 Percent change Standard Deviation 35.48	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40: Asymptomatic at Risk: DB Day 1	19.2 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	-4.9 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	4.7 Percent change Standard Deviation 40.27	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40:Asymptomatic at Risk: DB Week 24	-2.3 Percent change Standard Deviation 12.38	-75.2 Percent change Standard Deviation 10.16	-82.6 Percent change Standard Deviation 5.59	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40:Asymptomatic at Risk: DB Week 52	0.0 Percent change Standard Deviation 10.85	-74.9 Percent change Standard Deviation 6.76	-80.8 Percent change Standard Deviation 7.60	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40: Prodromal: DB Day 1	2.9 Percent change Standard Deviation 15.48	25.8 Percent change Standard Deviation 66.03	-24.2 Percent change Standard Deviation 41.31	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40: Prodromal: DB Week 24	8.6 Percent change Standard Deviation 18.57	-68.6 Percent change Standard Deviation 8.20	-82.5 Percent change Standard Deviation 7.38	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-40: Prodromal: DB Week 52	10.5 Percent change Standard Deviation 17.09	-70.9 Percent change Standard Deviation 9.24	-75.3 Percent change Standard Deviation 22.15	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42: Asymptomatic at Risk: DB Day 1	-5.9 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42:Asymptomatic at Risk:DB Week 24	-7.3 Percent change Standard Deviation 9.33	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42:Asymptomatic at Risk: DB Week 52	-6.0 Percent change Standard Deviation 2.69	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42: Prodromal: DB Day 1	-1.9 Percent change Standard Deviation 5.54	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42: Prodromal: DB Week 24	15.9 Percent change Standard Deviation 17.15	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels Plasma ABeta 1-42: Prodromal: DB Week 52	5.1 Percent change Standard Deviation 17.68	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, DB Day 1 and DB Week 52

The CSF samples were obtained for measuring levels of Tau protein and phosphorylated (p)-tau protein. Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).

Outcome measures

Outcome measures
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 Participants Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 Participants Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg n=26 Participants Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF Tau Protein: Asymptomatic at Risk: DB Week 52	-1.4 Percent change Standard Deviation 14.10	3.2 Percent change Standard Deviation 15.04	22.4 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF Tau Protein: Prodromal: DB Day 1	6.1 Percent change Standard Deviation 6.82	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF Tau Protein: Prodromal: DB Week 52	13.6 Percent change Standard Deviation 45.55	2.1 Percent change Standard Deviation 13.82	1.4 Percent change Standard Deviation 8.20	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF p-Tau Protein: Asymptomatic at Risk:DB Week 52	-4.6 Percent change Standard Deviation 6.47	-4.9 Percent change Standard Deviation 1.40	8.3 Percent change Standard Deviation NA Here NA signifies that Standard Deviation could not be calculated for a single participant.	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF p-Tau Protein: Prodromal: DB Day 1	-0.6 Percent change Standard Deviation 7.81	—	—	—	—	—	—
Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level CSF p-Tau Protein: Prodromal: Week 52	2.2 Percent change Standard Deviation 12.93	-2.7 Percent change Standard Deviation 10.52	-2.6 Percent change Standard Deviation 8.52	—	—	—	—

Adverse Events

Double-blind Treatment Phase (Period 1): Placebo

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Double-blind Treatment Phase (Period 1): Atabecestat 10 mg

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Double-blind Treatment Phase (Period 1): Atabecestat 25 mg

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

OL Phase (Period 2): Placebo to Atabecestat 25 mg

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 participants at risk Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 participants at risk Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 25 mg n=26 participants at risk Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg n=15 participants at risk Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg n=14 participants at risk Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg n=26 participants at risk Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg n=22 participants at risk Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Cardiac disorders Myocardial Ischaemia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Bronchitis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Pneumonia	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Pyelonephritis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Burns Third Degree	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Fall	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Hepatic Enzyme Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Transaminases Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Musculoskeletal and connective tissue disorders Foot Deformity	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Psychotic Disorder	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Renal and urinary disorders Calculus Urinary	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Renal and urinary disorders Renal Colic	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Renal and urinary disorders Ureteric Obstruction	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Reproductive system and breast disorders Menorrhagia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).

Other adverse events

Other adverse events
Measure	Double-blind Treatment Phase (Period 1): Placebo n=35 participants at risk Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 10 mg n=29 participants at risk Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Double-blind Treatment Phase (Period 1): Atabecestat 25 mg n=26 participants at risk Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.	Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg n=15 participants at risk Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Placebo to Atabecestat 25 mg n=14 participants at risk Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg n=26 participants at risk Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.	OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg n=22 participants at risk Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
Investigations Intraocular Pressure Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Ear and labyrinth disorders Ear Discomfort	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Cataract	17.1% 6/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Dry Eye	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Eye Pruritus	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Keratitis	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Lacrimation Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Macular Fibrosis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	9.1% 2/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Eye disorders Vitreous Floaters	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Constipation	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Diarrhoea	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	14.3% 2/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Diverticulum Intestinal	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Dysphagia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Gastrointestinal disorders Inguinal Hernia	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
General disorders Asthenia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
General disorders Malaise	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.9% 2/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Abscess Neck	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Bacterial Blepharitis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Bronchitis	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Candida Infection	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Cystitis	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Dermatophytosis of Nail	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Gastroenteritis Viral	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Influenza	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Nasopharyngitis	5.7% 2/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.9% 2/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	21.4% 3/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	11.5% 3/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Pneumonia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Upper Respiratory Tract Infection	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Infections and infestations Urinary Tract Infection	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Fall	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.9% 2/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Periorbital Haemorrhage	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Alanine Aminotransferase Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Hepatic Enzyme Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	21.4% 3/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Transaminases Increased	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.9% 2/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Investigations Weight Decreased	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	13.6% 3/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Musculoskeletal and connective tissue disorders Muscle Spasms	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Musculoskeletal and connective tissue disorders Osteoarthritis	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	9.1% 2/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Nervous system disorders Complex Regional Pain Syndrome	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Nervous system disorders Headache	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	14.3% 2/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	11.5% 3/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Nervous system disorders Tension Headache	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Confusional State	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Delirium	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Depression	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	13.3% 2/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Depressive Symptom	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.9% 2/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Insomnia	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.7% 2/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	9.1% 2/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Psychiatric disorders Nightmare	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	13.3% 2/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Renal and urinary disorders Nephrolithiasis	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Actinic Keratosis	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Hair Colour Changes	5.7% 2/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Nail Discolouration	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	7.1% 1/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	4.5% 1/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	5.7% 2/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Vascular disorders Hypertension	5.7% 2/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.8% 1/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Vascular disorders Hypotension	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	3.4% 1/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).
Vascular disorders Orthostatic Hypotension	0.00% 0/35 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/29 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	6.7% 1/15 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/14 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/26 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).	0.00% 0/22 • Up to 3 years Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER